Life Sciences 2024 Comparisons

Pharmaceuticals and medical devices in Malaysia are governed by the following legislation and regulations:

• the Sale of Drugs Act 1952;
• the Control of Drugs and Cosmetics Regulations 1984 (CDCR 1984);
• the Dangerous Drugs Act 1952;
• the Poisons Act 1952 (PA 1952);
• the Medicines (Advertisement and Sales Act) 1956 (MASA 1956); and
• the Medical Device Act 2012 (MDA 2012).

The main regulatory bodies for pharmaceuticals and medical devices are:

• the Drug Control Authority (DCA);
• the Pharmacy Board;
• the National Pharmaceutical Regulatory Agency (NPRA);
• the Medicine Advertisement Board; and
• the Medical Device Authority (MDA).

All of the above legislation and regulatory bodies are under the purview of the Malaysian Ministry of Health (MOH).

Appeals may be made against the decisions of the regulatory bodies in accordance with the procedure set out in the applicable act or regulations.

Under Regulation 18 of the CDCR 1984:

• any person aggrieved by the decision of the DCA or the Director of Pharmaceutical Services may make a written appeal to the Minister of Health for Malaysia;
• all notice of appeals shall be made within 14 days from the date of notification from the DCA; and
• any decision of the Minister made on an appeal shall be final.

Similarly, under Section 47 of the MDA 2012, a person aggrieved by the decision of the MDA may appeal to the Minister of Health for Malaysia.

A person who is adversely affected by a decision, action or omission in relation to the exercise of a public duty or function shall also be entitled to make an application to the court for judicial review, pursuant to Order 53 of the Rules of Court 2012. The following remedies may be sought under the judicial review application:

• mandamus (peremptory or mandatory order);
• certiorari (quashing order);
• prohibition (prohibition order); and
• damages.

Pharmaceutical products are categorised into:

• those containing the scheduled poison(s) listed in the PA 1952, which are categorised into the following different groups, which each have different registration requirements:
1. Group A for products with high toxicity;
2. Group B for prescription medicines;
3. Group C for non-prescription medicines; and
4. Group D for products for laboratory use; and
• those containing active ingredients that are not listed in the PA 1952 and that are not categorised as health supplements, natural products or cosmetics which may be freely available over the counter.

The wholesale and retail sale of pharmaceutical products are governed by Sections 15 and 16 of the PA 1952, respectively.

Medical devices are classified into four categories: Class A, B, C or D. The classification of these devices is detailed in the First Schedule of Medical Device Regulations 2012 and further elaborated in the Guidance on the Rules of Classification for General Medical Devices.

Malaysia does not have specific legislation to regulate clinical trials or research.

Clinical trials are regulated in Malaysia by the NPRA or the MDA, and are reviewed by Institutional Review Boards/Independent Ethics Committees (IRBs/IECs) of the organisation conducting the trials. Approvals from the Medical Research & Ethics Committee (MREC) for trials are required for trials using MOH facilities.

The NPRA ensures the quality, efficacy and safety of pharmaceuticals in Malaysia prior to release in the Malaysian market, and acts as a Secretariat to the DCA.

Pursuant to the Medical Device (Exemption) Order 2016, medical devices that are intended for clinical research or performance evaluation are exempted from the registration requirement under the MDA 2012.

The National Committee for Clinical Research is a steering committee empowered to establish policies and guidelines to enhance and regulate clinical research practice in Malaysia.

The DCA is empowered to review matters related to product registration, and to approve or reject applications for the following:

• a clinical trial import licence (CTIL), which is issued for the import of any product for purposes of clinical trials; or
• a clinical trial exemption (CTX), which is the authorisation to manufacture any product(s) solely for the purpose of producing samples for clinical trials.

Guidelines

The applicable clinical trial guidelines in Malaysia are as follows:

• the Malaysian Guideline for Good Clinical Practice, Fourth Edition, which adopts the basic principles outlined by the International Committee on Harmonisation of Good Clinical Practice, but with appropriate modifications to suit local requirements, effective since January 2018;
• the Malaysian Guideline for Application for Clinical Trial Import Licence and Clinical Trial Exemption in Malaysia, Edition 8.0, effective since March 2024;
• the Malaysian Guideline for Independent Ethics Committee Registration and Inspection, First Edition, effective since May 2016;
• the Malaysian Guidelines on the Use of Human Biological Samples for Research;
• the Guidelines for Good Clinical Practice (GCP) Inspection, Edition 2.1;
• the Malaysian Guideline for Phase I Unit Inspection and Accreditation Programme;
• the Malaysian Guideline for Independent Ethics Committee Registration and Inspection, First Edition;
• the Malaysian Guideline for BE Inspection, First Edition;
• the Malaysian Guideline for Safety Reporting of Investigational Products, First Edition; and
• Guidance Document and Guidelines for Registration of Cell and Gene Therapy Products (CGTPs) in Malaysia.

Directives

Directives from the Director of Pharmaceutical Services of the Pharmacy Board on the regulation of clinical trials include the following:

• all ethics committees that approve clinical trials in Malaysia must be registered with the DCA to regulate the quality, safety and efficacy of pharmaceutical products;
• all clinical trials requiring a CTIL/CTX must be registered with the National Medical Research Register (NMRR); and
• all bio-equivalence (BE) research conducted for the purpose of registering a product in Malaysia must be carried out in a BE research centre that has been listed in the NPRA’s BE Centre Compliance Programme.

Before commencing any clinical trial involving product(s), the investigator/sponsor/contract research organisation (CRO) must have secured the approval of the relevant IRB/IEC and the CTIL/CTX for the importation/manufacturing of the product locally for the study.

The following products will require a CTIL/CTX:

• a product, including a placebo, that is not registered with the DCA and is intended to be imported for clinical trial purposes;
• a product with a marketing authorisation when used or assembled (formulated or packaged) in a different way from the approved form, and when used for an unapproved indication or to gain further information about an approved use for clinical trial purposes;
• a traditional product with a marketing authorisation with an indication for “traditionally used” when used for unapproved indication/therapeutic claims for clinical trial purposes; and
• an unregistered product, including a placebo, that is manufactured locally for the purpose of the clinical trial.

IRBs/IECs

The committees to which the application should be submitted will depend on the location or facility where the clinical trial will be conducted.

Government health facilities under the MOH

Under the Malaysian National Institutes of Health’s Guidelines for Conducting Research in MOH Institutions and Facilities, all clinical trials involving MOH facilities must register with the NMRR and obtain prior approval from the MOH. The following requirements also apply:

• a government employee intending to act as an investigator for the clinical trial must sign an investigator agreement and obtain approval from the head of their department and the organisational or institutional director of the relevant government department – permission must be obtained to conduct research at the respective facilities/institutions;
• where a private institution undertakes collaborative research with the MOH, a Memorandum of Understanding and a Research Agreement must be executed between the related MOH institution or division and the private institution; and
• the NMRR will review the documents submitted – if it is satisfied with the registration application, the NMRR will forward them to the MREC for its review and approval.

Universities or private institutions

Applications are to be submitted to the respective IRB/IEC of the university or institution, which will review and approve the trial proposal as per the functions of the MREC. If the university or institution concerned does not have its own IRB/IEC, applications can be submitted to the MREC or any such committees of other universities or private institutions.

All ethics committees must be registered with the DCA.

The application to the IRB/IEC is made by the investigator – ie, the person responsible for the conduct of the trial or, where conducted by a team, the person who is the leader of the team (principal investigator), subject to the particular policies of that IRB/IEC.

Section 3.1.2 of the Guideline for Good Clinical Practice provides for the list of documentation to be submitted to the IRB/IEC for approval, which includes the following:

• trial protocol;
• written informed consent form;
• consent form updates;
• subject-recruitment procedures and other written information to be provided to subjects; and
• an investigator’s brochure, which is a compilation of the clinical and non-clinical data on the trial drug relevant to its study in human subjects.

There are no statutory requirements for clinical trials, nor for the results to be made publicly available.

Nevertheless, the NMRR online platform offers a publicly accessible database of medical research and clinical trials conducted in Malaysia. Additionally, some organisations also voluntarily publish their data on their websites – eg, Novartis provides technical results and trial summaries for patients from Phases 1 through 4 of interventional trials for innovative products within one year of trial completion, at their website.

There are no restrictions on using online tools to support clinical trials. Volunteers may be recruited through various online portals, such asClinical Research Malaysia and GSK Malaysia.

The data resulting from clinical trials would be considered “sensitive personal data” under Section 4 of the Personal Data Protection Act 2010 (PDPA 2010), which defines sensitive personal data as any personal data consisting of information on the physical or mental health or condition of a data subject.

Under Section 40 of the PDPA 2010, any disclosure or processing of sensitive personal data may only be made if the data subject has given their explicit consent to do so, or if any of the special circumstances set out in Section 40(1)(b) of the PDPA 2010 are satisfied.

The creation of a database containing personal or sensitive data constitutes the “processing” of data under the PDPA 2010 and would therefore be subject to the seven Personal Data Principles, as set out in Sections 5 to 12 of the PDPA 2010:

• the General Principle;
• the Notice and Choice Principle;
• the Disclosure Principle;
• the Security Principle;
• the Retention Principle;
• the Data Integrity Principle; and
• the Access Principle.

Furthermore, a data user/processing body that falls under any of the classes under the Personal Data Protection (Class of Data Users) Order 2013 would also need to obtain a certificate of registration in accordance with Sections 12 to 20 of the PDPA 2010 prior to processing personal data.

The NPRA uses the following criteria to assist in the classification of products as either pharmaceuticals or medical devices: 

• the primary intended purpose of the product;
• the primary mode of action/the principal mechanism of action by which the claimed effect or purpose of the product is achieved – a drug is based on pharmacological, immunological or metabolic action in/on the body, whereas a medical device does not achieve its primary mode of action in or on the human body by pharmacological, immunological or metabolic means, but may be assisted in its intended function by such means;
• the active ingredient, indication and pharmaceutical dosage form (these are the main criteria for classification of the drugs); and
• the classification of the products in reference countries.

Medical devices are classified into Class A, B, C or D, based on the risk associated with the vulnerability of the human body, the technical design and the manufacture of the medical device, with different registration requirements and registration fees. The classification rules are based on:

• intended use;
• duration of use (transient, short-term and long-term); and
• the part of the human body (non-invasive or invasive with respect to body orifices, surgically invasive interventions, central circulatory system, central nervous system, etc).

The NPRA’s requirements for the registration of biologic/biopharmaceutical products are aligned with the scientific guidelines and recommendations established by the World Health Organization, the European Medicines Agency and the International Conference of Harmonisation (ICH). These standards cover quality, clinical effectiveness and safety.

Every biologic is regulated as a new product. Both substance and drug-product production must comply with Good Manufacturing Practice strictly and in accordance with the ASEAN Common Technical Dossier (ACTD) format.

Biologics such as vaccines, biotechnology products and blood products have special registration requirements which are detailed in the Drug Registration Guidance Document, Third Edition.

Registration/marketing authorisations for pharmaceutical and medical devices are valid for five years (unless they are suspended sooner or cancelled by the relevant authority). The renewal of a pharmaceutical registration should be submitted within six months prior to the expiry of the validity period, while a medical device re-registration can be submitted within one year prior to the expiry date, together with the appropriate fee.

To obtain a marketing authorisation for both pharmaceuticals and medical devices, the product must be registered with the relevant authorities.

Pharmaceuticals

The registration process for pharmaceuticals may be summarised as follows.

Pre-submission of Application

The applicant needs to determine the category of the product – ie, whether it is a:

• new drug product;
• biologic;
• generic;
• health supplement; or
• natural product.

Method of Evaluation

There are four methods of evaluating the application:

• full evaluation;
• full evaluation (conditional registration), for a product that must be registered in at least one DCA reference agency; a conditional registration is valid for two years and may be renewed twice (with the possibility of two extensions of two years each);
• full evaluation via abbreviated and verification review, for a product that has been evaluated and approved by one reference drug regulatory agency – the verification review applies to a product that has been evaluated and approved by two reference drug regulatory agencies; and
• abridged evaluation.

The following general requirements for full evaluation are in accordance with ACTD/ASEAN Common Technical Requirements or ICH guidelines:

• Part I Administrative data and product information;
• Part II Data to support product quality (Quality Document);
• Part III Data to support product safety (Non-clinical Document); and
• Part IV Data to support product safety and efficacy (Clinical Document).

For an abridged evaluation, a bio-availability study and a bio-equivalence study are required.

Submission of Application

An application for product registration shall be submitted only via the online QUEST3+ System. To conduct transactions via the QUEST3+ System, the applicant must first register membership with the National Pharmaceutical Control Bureau and purchase a USB Token that contains a User Digital Certificate, which shall be installed on the applicant’s computer. Once the Digital Certificate is installed, the applicant may conduct transactions for product registration and licensing in the system.

Decisions of the Authority

A regulatory decision shall be made based on the outcome of the evaluation of the submitted documentation, and samples (if applicable). An application may be approved or rejected by the DCA, and the DCA’s decision will be sent via email/official letter to the product registration-holder. Every registered product is accompanied by a registration number which must be printed on its label or package.

Post-registration Process

After the product is registered, the applicant must apply for a manufacturer, import or wholesale licence and shall fulfil all commitments and conditions imposed during the approval of the product registration, and be responsible for the maintenance of the product in terms of quality, safety and efficacy throughout the validity period of registration. Failure to do so may result in the rejection of an application for the renewal of a product registration. The DCA shall also be notified of any changes to the product’s efficacy, quality and safety.

Any person who is aggrieved by the decision of the DCA or the Director of Pharmaceutical Services may make a written appeal to the Minister of Health Malaysia. The re-submission of product registration that was rejected for reasons of safety and efficacy shall not be accepted within two years after the rejection. However, if the product is registered in the reference countries, the submission of an application can be made earlier.

Variation of Marketing Authorisation

Two types of variations may be made to a marketing authorisation:

• major variation (MaV) – this is a variation to a registered pharmaceutical finished product that may significantly and/or directly affect the aspects of quality, safety and efficacy and does not fall within the definition of minor variation and new registration – change-of-content of product labelling, change of batch site of sterile drug product, etc; or
• minor variation (MiV-N & MiV-PA) – this is a variation to a registered pharmaceutical finished product in terms of administrative data and/or changes with minimal/no significant impact on the aspects of efficacy, quality and safety – change of product name, the specification of drug substance, etc.

Medical Devices

The registration process for medical devices may be summarised as follows.

Pre-submission of application

The applicant should first determine the device’s classification according to the First Schedule of Medical Device Regulations 2012. Thereafter, a conformity assessment shall be undertaken to collect the evidence of conformity, which shall be verified by a registered Conformity Assessment Body (CAB). The CAB will subsequently issue a certificate of conformity and a report for the purposes of submission for registration.

Submission of application

Application for registration of a medical device may be made after supporting documents are available. Application for medical device registration shall be submitted online through MeDC@St2.0+. The form consists of eight parts as follows:

• general information of the device;
• information of manufacturer;
• grouping of device;
• Common Submission Dossier Template (CSDT) which can be found in Appendix 2 of Third Schedule of the Medical Device Regulations 2012;
• supporting documents for CSDT;
• post-market vigilance history;
• declaration of conformity in accordance with Appendix 3 of Third Schedule of the Medical Device Regulations 2012; and
• attestation for medical device registration application. 

Decisions of the authority

The MDA may reject an application if it lacks sufficient information or includes incorrect documentation. Applicants will receive the decision through email and will be given an opportunity to resubmit the requested information within the request date. Every registered product is accompanied by a registration number which must be printed on its label in a manner that is legible, permanent and prominent.

Transfer of marketing authorisation

It is permissible to transfer the market authorisation from one marketing authorisation holder to another. Upon the approval of the transfer of marketing authorisation, the former product registration holder shall no longer have marketing authorisation over the registered product.

The licence required to manufacture or supply a product does not apply to the dispensing of any drug for the purpose of it being used for the medical treatment of a patient or animal by a pharmacist, a fully licensed medical, dental or veterinary practitioner or a person employed in a governmental hospital or dispensary to dispense drugs.

Under Regulation 15(6) of the CDCR 1984, any person who wishes to import or manufacture any product solely for the purpose of treating any person suffering from a life-threatening illness may, upon application, be exempted from having to obtain marketing authorisation.

The Medical Device (Exemption) Order 2016 has provided for medical devices to be exempted from registration requirement if they are used for personal use, educational, investigational, or other specific defined purposes. The manufacturer or supplier seeking to supply such medical device must first submit a notification to the MDA for an exemption.

Product registration holders of pharmaceutical products are required to carry out pharmacovigilance. Pursuant to the CDCR 1984, product registration holders shall inform the Director of Pharmaceutical Services immediately of any adverse reaction arising from the use of the registered product.

All product registration holders must ensure that the company has a pharmacovigilance system in place and that appropriate action is taken, when necessary.

Product registration holders are required to monitor and report any product safety issues that arise locally or internationally to the NPRA, and to comply with all safety-related directives issued by the NPRA.

The product registration may be cancelled if the product registration holder fails to inform the NPRA of any serious adverse reactions upon receipt of such reports. For further information, reference may also be made to the Malaysian Guidelines on Good Pharmacovigilance Practices (GVP) for Product Registration Holders, First Edition, which contains guidelines for the establishment of a pharmacovigilance system.

The Malaysian Adverse Drug Reactions Advisory Committee is an advisory body to the DCA to supervise pharmacovigilance activities for medicinal products registered in Malaysia.

In relation to medical devices, Section 38 of the MDA 2012 requires the holder of a marketing authorisation to monitor the safety and performance of the medical device, and to put a post-market surveillance system in place.

All information declared in the registration form for marketing authorisations of pharmaceuticals is confidential and is not accessible to third parties.

In relation to medical devices, the applicant must apply to the MDA for any information relating to the application to be kept confidential. The grant of confidentiality is at the discretion of the MDA, and consideration will be given to the criteria stated in Section 68(3) of the MDA 2012. If confidentiality is not granted, Section 69 of the MDA 2012 stipulates that, subject to the discretion of the MDA, the public may have access to such information relating to the application.

Information relating to individuals is governed by the PDPA 2010. Any disclosure or processing of sensitive personal data may only be made if the data subject has given their explicit consent to do so. Notwithstanding the requirement for explicit consent from the data subject, Section 40 of the PDPA 2010 also allows the processing of sensitive personal data where:

• the processing is necessary for the following reasons:
1. to exercise or perform any right or obligation that is conferred or imposed by law on the data user in connection with employment;
2. in order to protect the vital interests of the data subject or another person, in a case where consent cannot be given by or on behalf of the data subject or the data user cannot reasonably be expected to obtain the consent of the data subject;
3. in order to protect the vital interest of another person, in a case where consent by or on behalf of the data subject is unreasonably withheld;
4. for medical purposes and the processing is undertaken by a healthcare professional;
5. for any legal proceeding;
6. to obtain legal advice;
7. for the administration of justice;
8. for the exercise of any functions conferred by law; or
9. for any purpose the Minister deems fit; or
• the information contained in the personal data has been made public as a result of steps taken deliberately by the data subject.

Pharmaceutical Products

Regulations 7 and 18A of the CDCR 1984 prohibit the illegal distribution of drugs and cosmetics products. A person who commits an offence under the CDCR 1984 is liable to a fine not exceeding MYR20,000 or to imprisonment for a term not exceeding three years, or to both.

Medical Devices

Section 5(2) of the MDA 2012 provides that any person who imports, exports or places on the market an unregistered medical device commits an offence, and shall be liable to a fine not exceeding MYR2 million or to imprisonment for a term not exceeding three years, or to both.       

Issues relating to counterfeiting are dealt with under the Trademarks Act 2019, under Section 82(1) which states that any person may file an application to the Registrar, stating that:

• they are the registered proprietor, or the licensee having the power to file such application;
• at a time and place specified in the application, goods infringing the registered trade mark are to be imported for the purpose of trade; and
• they object to that importation.

Upon approval by the Registrar, the importation of any infringing goods into Malaysia for the duration of the period specified in the approval shall be prohibited. An approval shall remain in force until the end of a 60-day period commencing on the day of the approval, unless withdrawn earlier by the applicant. Where goods have been seized pursuant to the application, the applicant must take action for infringement within the retention period, otherwise the goods shall be released back to the importer and the applicant may be further liable for loss or damage suffered by the importer as a result of the seizure.

Under Regulation 7(1) of the CDCR 1984, except as otherwise provided therein, no person shall manufacture, sell, supply, import, possess or administer any product unless the product is a registered product and the person holds the appropriate licence required and issued under the Regulations. Thus, any company carrying out the manufacture, import or wholesale of any registered products must hold a manufacturer’s licence, import licence or wholesale licence. The Director of Pharmaceutical Services grants the authorisation.

An application for a manufacturer’s licence for pharmaceutical products can be made online through the QUEST3+ System. To qualify for the application, the company must be a Product Registration Holder or is appointed by the holder as a contract manufacturer for registered products. Additionally, the manufacturing site must meet the standards of Good Manufacturing Practice and Good Distribution Practice. If the establishment intends to handle scheduled poisons listed under the First Schedule of the PA 1952, it is mandatory to appoint a pharmacist who has a Type A Poison License.

Once the manufacturer’s licence is granted, the applicant can manufacture registered products in their premises and can sell by wholesale, or supply the registered products.

The manufacturer’s licence for pharmaceutical products is valid for one year, from 1 January to 31 December of the same year.

Medical Devices

All establishments (ie, manufacturer, authorised representative, importer and distributor) must apply for an establishment licence. However, only manufacturers and authorised representatives need to apply for medical device registration under Section 15 of the MDA 2012. The MDA grants the authorisation of an establishment licence.

The application for an establishment licence can be made at MeDC@St2.0+. A flow chart of the application process is provided on the website. With the establishment licence, the manufacturer can import, export or place any registered medical device on the market.

The establishment licence is valid for three years, and an establishment can start to renew the licence one year prior to the expiry date.

Establishments engaged in the wholesale of pharmaceutical products are required to obtain a wholesale licence under the CDCR 1984. An application for a wholesaler licence for pharmaceutical products can be made online through the QUEST3+ System. If the establishment intends to handle scheduled poisons listed under the First Schedule of the PA 1952, it is mandatory to appoint a pharmacist who has a Type A Poison License.

The Guideline on Application of Manufacturer’s, Import and Wholesaler’s Licenses for Registered Products, Second Edition details the procedures for application of the licences for registered products.

Once the wholesaler’s licence is granted, the licence holder can sell by wholesale or supply registered products from their premises. The licence holder is also required to comply with the principles of Good Distribution Practice. The Wholesaler’s Licence for pharmaceutical products is valid for one year, from 1 January to 31 December of the same year.

Medical Devices

For medical devices, a distributor shall obtain an establishment licence to conduct its activity. With an establishment licence, a distributor can import, export or place any registered medical device on the market.

The classifications of drugs can be found in the First Schedule of the PA 1952, where drugs are classified into the following:

• Group A Poison – high-toxicity medicines – eg, alclofenac, amidopyrine, avoparcin;
• Group B Poison – used in treatment where a doctor’s diagnosis is needed to recognise the symptoms, and can be dispensed only against prescription – eg, nifedipine, olanzapine, ramipril;
• Group C Poison – used in treatment where the symptoms are easily recognised, and can be dispensed without prescription – eg, ibuprofen, piroxicam, mefenamic acid; and
• Group D Poison – chemicals for laboratory use – eg, cetyl chloride, ethylidene diacetate, methyl bromide.

The CDCR 1984 governs the import and export of pharmaceuticals. Under Regulation 7(1) of the CDCR 1984, except as otherwise provided therein, no person shall manufacture, sell, supply, import, possess or administer any product unless the product is a registered product and the person holds an import licence required and issued under these Regulations.

An application for an importer’s licence for pharmaceutical products can be made online through the QUEST3+ System. To qualify for the application, the company must be a Product Registration Holder or is appointed by the holder as a contract manufacturer for registered products. Additionally, the importer’s premise must meet the requirements of Good Distribution Practice. If the establishment intends to handle scheduled poisons listed under the First Schedule of the PA 1952, it is mandatory to appoint a pharmacist who has a Type A Poison License. With an import licence, the licence holder can import or sell by wholesale or supply registered products.

Section 12 of the Dangerous Drugs Act 1952 prohibits the import of any dangerous drugs specified in Parts III, IV and V of the First Schedule thereof and the export of any dangerous drug specified in Parts III and IV unless otherwise authorised by the Minister of Health.

Medical Devices

The MDA 2012 governs the import and export of medical devices. The importation, exportation, or placement of a medical device in the Malaysia market requires the medical device to be registered under MDA 2012. Importers are also required to obtain an establishment licence.

A special exemption exists for exportation of export only medical devices. Pursuant to the Circular Letter of Medical Device Authority No 4, medical devices intended solely for export are exempted from the registration requirements under the MDA 2012. Instead, an exporter need only apply for an Export Only Medical Device Exemption Letter issued by the MDA.

Over and above, it is pertinent to note that at the point of entry, import regulations are applied and enforced by the Royal Malaysian Customs Department, specifically the Import Management & Enforcement Unit and the Export Management & Enforcement Unit under the Customs Division.

For a CTIL (for the import of any product for purposes of clinical trials, notwithstanding that the product is not a registered product), only an investigator or an authorised person from a locally registered pharmaceutical company/sponsor/CRO with a permanent address in Malaysia can act as an importer of record of pharmaceuticals and medical devices in the country.

An application for a CTIL/CTX containing a “poison/drug” should be made by a Poison Licence Type A holder for a pharmacist in the private sector or an Annual Retention Certificate holder for a public pharmacist. However, it should be noted that the holder of a CTIL/CTX for a particular product need not necessarily conduct the clinical trial themselves.

The importation of pharmaceuticals and medical devices is subject to prior authorisation, as stated in Regulation 7 of the CDCR 1984, Section 8 of the PA 1952 and Section 15 of the MDA 2012.

There are exemptions regarding those authorisations. Special exemptions for the importation of products that are not registered with the DCA may be granted for the treatment of life-threatening illnesses, as provided under Regulation 15 (6) of the CDCR 1984.

Licences are required prior to the importation of any poison into Malaysia, under Section 8 of the PA 1952.

The categories of licences can be found in Section 26(2)(a) of the PA 1952:

• Type A licence issued to a pharmacist to import, store and deal in all poisons generally by wholesale and retail or by wholesale only or by retail only, subject to this Act;
• Type B licence issued to any person who is deemed fit or a responsible officer of a company to import, store and sell by wholesale any such poisons (not being a Group A Poison) as may be specified in such a licence;
• Type C licence issued to any person (in this Act referred to as “a listed seller”) the licensing officer considers to be a fit and proper person to hold such a licence, to store and sell by retail Group F Poisons only;
• Type D licence issued to any person the licensing officer considers to be a fit and proper person to hold such a licence, to store and sell by retail any such Part II Poisons as may be specified therein; and
• Type E licence issued to any person who, in the course of their business, uses sodium hydroxide in such a substantial quantity that the licensing officer deems it appropriate to issue them a licence to import, store and use sodium hydroxide.

Section 30 of the PA 1952 further states that any psychotropic substances listed in the Third Schedule of the Act cannot be imported, exported, manufactured, compounded, mixed, dispensed, sold, supplied, administered, possessed or used, unless it is in accordance with the regulations applicable under the PA 1952.

Section 12 of the Customs Act 1967 further prohibits the importation and exportation of any dangerous drugs specified in Parts III, IV and V of the First Schedule thereof, unless otherwise authorised by the Minister.

Malaysia has already signed and implemented seven bilateral free trade agreements (FTAs), with Japan, Pakistan, India, New Zealand, Chile, Australia and Turkey.

At the ASEAN level, Malaysia has nine regional FTAs, with China, Korea, Japan, Australia, New Zealand Hong Kong and India, as well as the ASEAN Free Trade Agreement (AFTA), Regional Comprehensive Economic Partnership (RCEP) and Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP).

The prices of pharmaceuticals and medical devices are not regulated in Malaysia.

In 2006, the Malaysian government introduced the Malaysian National Medicines Policy to promote equitable access and rational use of medicines for public health. The policy is revised and reissued every four years. Aligned with this Policy, various strategies have been introduced to ensure medicine prices are fair and affordable for Malaysians. Among these strategies, the Pharmaceutical Services Programme offers a list of medicines prices on its website which aims to assist the public with purchasing medicines in the private sector. This consumer price guide offers details on the availability and suggested retail prices of medicines as determined by the product registration holder, enabling consumers to make informed decisions. In the public sector, the MOH indirectly controls and reduces medicine prices with bulk purchases through concession supply and national tenders to provide accessible and affordable medicines.

Currently, the price level of a pharmaceutical or medical device does not depend on the prices for the same product in other countries.

In the Medicine Price Monitoring Report 2020 issued by the MOH, a comparison was made between the international reference price and the procurement price in the public and private sectors in Malaysia. Pursuant to this, there have been discussions on the introduction of drug price regulations, but no concrete actions have yet been taken.

In Malaysia, the government-based and publicly funded sectors provide health services that are tax-funded and administered by the MOH through its central, state and district offices. The policies and programmes are centrally formulated, funded and administered.

There is no formal reimbursement system in Malaysia for pharmaceuticals or medical devices.

Although health technology assessments play a role in the formulation of drug policies in Malaysia, cost-effectiveness evidence is currently not mandatory, although it is of interest to decision-makers.

In Malaysia, the prescription and dispensing of pharmaceuticals are currently governed by the PA 1952, the Poisons Regulations 1952 and the Poisons (Psychotropic Substances) Regulations 1989.

The Guide to Good Dispensing Practice 2016 establishes guidelines and procedures for good dispensing practice. It categorises the dispensing process into the following key areas: screening of prescriptions, preparation of medicines, supplying the medicines, recording and counselling.

The Guide also emphasises the importance of proper record keeping. It mandates that whenever any poison is sold or supplied as a dispensed medicine or as an ingredient in a dispensed medicine, the seller or supplier shall record certain information in a Prescription Book, which includes the date of sale, the serial number of the entry, the name of the poison and the ingredients of the medicine, the quantity supplied, etc.

There are no specific rules that govern medical apps in Malaysia. However, the definition of medical devices under Section 2 of the MDA 2012 includes:

• any software for the purpose as specified in paragraphs (i) to (vii) of Section 2 that does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means; or
• any software to be used on the human body, which the Minister may, after taking issues of public safety, public health or public risk into consideration, declare to be a medical device by an order published in the Gazette.

As such, the MDA 2012 shall apply to medical apps that are used for purposes within the definition of a medical device under the Act. The application for the registration of a medical device is, in turn, governed by Section 6 of the MDA 2012.

The Telemedicine Act 1997 was introduced in 1997 but is not yet in force. Telemedicine is defined as the practice of medicine using audio, visual and data communications.

Section 3 of the Telemedicine Act provides that only a fully registered medical practitioner holding a valid practising certificate or a medical practitioner who is registered or licensed outside Malaysia and holds a certificate to practise telemedicine issued by the council and practises telemedicine from outside Malaysia through a fully registered medical practitioner holding a valid practising certificate is authorised to practise in Malaysia.

Section 2 of the MASA 1956 defines an advertisement to include any notice, circular, report, commentary, pamphlet, label, wrapper or other document, and any announcement made orally or by any means of producing or transmitting light or sound. The Guideline on Advertising of Medicines and Medicinal Products to General Public lists online advertising as an example of advertisement under the definition in Section 2.

The MASA 1956 governs any online advertising of medicines and medical devices in Malaysia. As advertising on online platforms is regulated, conditions imposed by the MASA 1956 shall be followed. Accordingly, online advertisement is subject to approval by the Medical Advertisement Board.

The Medical Device (Advertising) Regulations 2019 govern matters relating to the contents and conditions for the advertising of medical devices and provide that approval must be obtained to advertise a registered medical device.

Electronic prescriptions are now allowed via the amendments under the Poisons (Amendment) Act 2022.

Pursuant to the amendments brought under the Poisons (Amendment) Act 2022, electronic prescriptions are now allowed for Group B Poison. Section 21(2A) of the PA 1952 provides that every electronic prescription shall adhere to the following:

• created and dated in electronic form;
• signed with a digital signature by the prescriber;
• sent to a registered pharmacist as an electronic message;
• state the name and address of the prescriber;
• state the name and address of the patient or, in the case of a prescription by a registered veterinary surgeon, the name and address of the person to whom such medicine is to be delivered;
• indicate the total amount of medicine to be supplied and the dose; and
• specify the number of times (not exceeding three) the medicine may be dispensed and, if dispensed more than once, at what intervals.

Under Section 13 of the PA 1952, it is against the law to sell or supply medicine without a licence. Violators may face fine up to MYR50,000 or receive a term of imprisonment not exceeding five years or both. Similarly, under Section 5 of the MDA 2012, selling unregistered medical device attracts a fine not exceeding MYR 200,000 or imprisonment for a term not exceeding three years or both.

While the sale of medicines and medical devices online is not regulated by any specific piece of legislation, the seller must comply with the Consumer Protection (Electronic Trade Transactions) Regulations 2012.

Health-related information is regulated as sensitive personal data, as defined in Section 4 of the PDPA 2010. Sensitive personal data includes personal data consisting of information on the physical or mental health or condition of a data subject.

The processing of such information is governed by Section 40 of the PDPA 2010, which states that sensitive personal data may only be processed if the data subject has given their explicit consent or if the processing is necessary under certain circumstances set out in the PDPA 2010.

In terms of the storing of information in cloud platforms, the Malaysian Department of Personal Data Protection issued a Personal Data Protection Standard in 2015, which states that the transfer of personal data through cloud platforms is not permitted unless written consent is obtained from an officer authorised by the top management of the data user organisation. The transfer of personal data through cloud platforms must comply with personal data protection principles in Malaysia, and with the personal data protection laws of other countries.

Patent rights in Malaysia are governed by the Patents Act 1983 (PA 1983), together with the Patents Regulations 1986.

The issue most commonly encountered by pharmaceutical and medical devices products under the legislation is patent infringement.

There is no specific patentability requirement for pharmaceuticals or medical devices.

The patenting of second and subsequent medical uses is expressly permitted under Section 14(4) of the PA 1983. Inventions in relation to new dosage regimes or selected patient populations are patentable in Malaysia if they satisfy the novelty and inventiveness patentability requirements.

A patent is infringed when a product or process falling within the scope of the protection of the patent, as defined by the claims in the patent, is exploited without the patentee’s consent.

Section 35 of the PA 1983 states that the term of protection of a patent shall be 20 years. There is currently no provision for patent term extension in Malaysia.

The patentee’s exclusive right to exploit a patent allows them to exclusively use the patented product or patented process and to make, import, offer for sale or sell the patented product and any product obtained directly by means of the patented process. A patent is infringed when there is any unauthorised exploitation thereof.

However, Section 37(1A) of the PA 1983 provides that “the rights under the patent shall not extend to acts done to make, use, offer to sell or sell a patented invention solely for uses reasonably related to the development and submission of information to the relevant authority either in Malaysia or outside Malaysia which regulates the manufacture, use or sale of pharmaceutical products”. Accordingly, applications for marketing authorisations for pharmaceutical products (but not medical devices) will not infringe the patent.

A cause of action for “imminent infringement” is also available in Malaysia, as provided for under Section 59(2) of the PA 1983. It is arguable that an application for marketing authorisation constitutes “imminent infringement” of a subsisting patent in relation to the product. However, this interpretation should be read in light of Section 37(1A) of the PA 1983.

In Malaysia, the Bolar exemption is encapsulated in Section 37(1) of the PA 1983, which limits the rights under the patent to acts done for industrial or commercial purposes and not to acts done only for experimental or scientific research. Section 37(1A) of the PA 1983 further provides that a patentee’s rights shall not extend to acts done in relation to a patented invention solely for uses reasonably related to the development and submission of information to the relevant authority either in Malaysia or outside Malaysia that regulates the manufacture, use or sale of pharmaceutical products. It should be highlighted that the applicability of Section 37(1A) of the PA 1983 is limited to pharmaceutical products; it does not cover medical devices.

As a pre-emptive measure, an interested person may apply to court against the patent owner for a declaration under Section 62 of the PA 1983 that the performance of a specific act does not constitute an infringement of a patent.

Defences

The following defences to a patent infringement action are available:

• the claims of the patent allegedly infringed are invalid;
• the product complained of was not obtained by the patented process or, at any rate, not directly;
• the patentee has exhausted their rights – ie, the patented product or product obtained directly by means of the patented process was produced in Malaysia or elsewhere by or with the consent, conditional or otherwise, of the owner of the patent or of their licensee;
• the acts complained of were done privately either for purposes that are not industrial or commercial, or for scientific research relating to the subject matter of the invention;
• the acts complained of were reasonably related to the development and submission of information to the relevant authority that regulates the manufacture, use or sale of drugs (Bolar exemption);
• the acts complained of were done in connection with a foreign vessel, aircraft, spacecraft or land vehicle temporarily in Malaysia;
• the acts were done after notification in the Gazette that the patent has lapsed and before notification in the Gazette that the patent has been reinstated;
• the rights were done pursuant to a compulsory licence;
• the act was authorised by the government; and
• the “Gillette” defence, under which the alleged infringement is old or obvious – ie, what the defendant is doing differs from what was known before the date of the patent only in non-patentable variations.

Compulsory Licences

Under Section 49 of the PA 1983, an application for a compulsory licence may be made after the expiration of three years from the grant of patent or four years from the filing date of the patent application, whichever is the later, on the following grounds:

• where there is no production of the patented product or application of the patented process in Malaysia without any legitimate reason; or
• there is no product produced in Malaysia under the patent for sale in any domestic market, or there are some but they do not meet the public demand without any legitimate reason.

Notwithstanding the above, a compulsory licence may be granted any time after the grant of patent in the following circumstances:

• where the patented products are sold in the domestic market at unreasonably high prices without any legitimate reason; or
• for the purposes of production of a pharmaceutical product in Malaysia and the exportation of such pharmaceutical product to an eligible importing country to deal with its public health problem.

Prior to making an application to the Patent Registrar for a compulsory licence, the applicant shall first attempt to obtain authorisation from the owner of the patent on reasonable commercial terms.

Under Section 84 of the PA 1983, a government agency may exploit a patented invention under a government-use licence without the consent of the patent owner if there is a national emergency or where such is required by public interest; or where a judicial or relevant authority has determined that the manner of exploitation by the patent owner or their licensee is anti-competitive.

A patentee may bring a civil action against an infringer at the High Court. A patent infringement action generally begins by filing a writ of summons against the infringer. The procedure to be complied with for an action by writ is governed by Orders 6 and 10 of the Rules of Court 2012.

Remedies

A plaintiff in an infringement action may claim and obtain the following:

• an injunction (including a quia timet, interlocutory injunction and permanent injunction) restraining the defendant from any act of infringement or imminent infringement;
• an order for the delivery up or destruction of any patented product in relation to which the patent is infringed or any article in which that product is inextricably comprised;
• damages in respect of the infringement;
• alternatively, an account of the profits derived by the defendant from the infringement;
• a declaration that the patent has been infringed by the defendant and (if validity has been successfully contested) that the patent is valid;
• interest on any sum found payable; and
• further or other relief and costs.

Invalidation

A defendant in an infringement action may counterclaim for an invalidation of the patent on the following grounds:

• that it is not an invention – ie, not an idea that permits, in practice, a solution to a specific problem in the field of technology;
• that it is not patentable – the alleged invention is excluded from being patentable with reference to the following:
1. discoveries, scientific theories and mathematical methods;
2. plant or animal varieties or essentially biological processes for the production of plants or animals, other than manmade living micro-organisms, microbiological processes and the products of such micro-organism processes;
3. schemes, rules or methods for doing business, performing purely mental acts or playing games; and
4. methods for the treatment of human or animal bodies by surgery or therapy, and diagnostic methods practised on the human or animal body;
• that it is contrary to public policy – ie, the performance of any act in respect of the claimed invention would be contrary to public order or morality;
• that it is not new – ie, the alleged invention has been anticipated by prior art, which is defined as everything disclosed to the public, anywhere in the world, by written publication, by oral disclosure, by use or in any other way, before the priority date of the claim;
• that there is no inventive step – the invention is obvious, having regard to what was known or used before the priority date;
• that it is not industrially applicable – the invention cannot be made or used in any of kind of industry;
• that the description or claim does not comply with the Patents Regulations 1986 – the specification is ambiguous or does not sufficiently and fairly describe the invention and the method by which it is to be performed, or does not disclose the best method known to the applicant for the patent and for which they were entitled to claim protection;
• that the drawings that are necessary for the understanding of the claimed invention have not been furnished;
• that the patentee is not entitled – ie, the right to the patent does not belong to the person to whom the patent was granted; and
• that there is incomplete or incorrect information – false or incomplete information has been deliberately provided, or caused to be provided, to the Registrar when filing a request for substantive examination by the patentee or their agent.

At the pre-submission stage of the application to the NPRA, the potential generic entrant shall provide the NPRA with a declaration that it shall comply with all legal provisions in Malaysia and conform to the PA 1983, and that it shall not market, sell, offer for sale or store any registered product containing any patented active ingredient(s) for which the patent duration has yet to expire.

A potential generic entrant who qualifies as an interested person shall have the right to apply for a declaration from the court against the owner of a patent that the performance of a specific act does not constitute an infringement of the patent, provided that the act in question is not already the subject of infringement proceedings. These proceedings for a declaration of non-infringement may be instituted together with the invalidation proceedings.

Issues of counterfeits are generally dealt with under the Trademarks Act 2019. In addition to civil remedies pursuant to trade mark infringement, any person who counterfeits a registered trade mark commits an offence and would be liable to criminal sanctions as well.

Issues of counterfeiting may also infringe the intellectual property rights residing in the packaging/container of the pharmaceutical and medical device – eg, design rights under the Industrial Designs Act 1996 and copyrighted works in the literary and artistic works in the package inserts. An infringement proceeding for industrial designs is by way of a civil action taken by the owner against any person who has infringed the rights conferred by the registered industrial design, as provided under Section 33 of the Industrial Designs Act 1996.

The Trademarks Act 2019 does not impose any restrictions on trade marks that can be used for pharmaceuticals and medical devices.

In the now-repealed Trade Marks Act 1976, parallel imports were allowed on the principle of the exhaustion of rights, which is encapsulated in Sections 40(1)(d) and 40(1)(dd) and reads:

“(1) Notwithstanding anything contained in this Act, the following acts do not constitute an infringement of a trade mark:

(d) in relation to goods connected in the course of trade with the registered proprietor or a registered user of the trade mark if, as to those goods or a bulk of which they form part, the registered proprietor or the registered user in conforming to the permitted use has applied the trade mark and has not subsequently removed or obliterated it or has at any time expressly or impliedly consented to the use of the trade mark;

(dd) the use by a person of a trade mark in relation to goods or services to which the registered proprietor or registered user has at any time expressly or impliedly consented to…”.

However, only Section 40(1)(dd) was retained in the new Trademarks Act 2019, in Section 55(3)(c), so it is unclear whether the previous case law discussing Sections 40(d) and 40(dd) remains applicable.

The Trademarks Act 2019 allows for the shape of goods or their packaging to be registered as a trade mark, as long as it fulfils the general requirements for registration. Therefore, a registered mark for the shape or packaging will be granted trade mark rights.

Unregistered trade dress or design for pharmaceuticals, medical devices or their packaging may be protected in Malaysia under the common law tort of passing off. To establish a claim for passing off, the following elements must be satisfied:

• the plaintiff has sufficient reputation or goodwill in the mark;
• the defendant has misrepresented to the relevant members of the trade/public, as a result of which they are misled or likely to be misled into believing that the goods are endorsed, permitted and/or licensed by the claimant or affiliated with the claimant; and
• the plaintiff has suffered or is likely to suffer damage or injury to its business or goodwill by reason of the defendant’s misrepresentation.

Trade dress or design of pharmaceuticals and medical devices such as tablets may further be registered and protected under the Industrial Designs Act 1996, as they fall under the definition of “features of shape, configuration, pattern or ornament applied to an article by any industrial process or means”.

In Malaysia, undisclosed, unpublished and non-public domain pharmaceutical test data is protected under Directive No 2 on Data Exclusivity 2011, which was issued by the Director of Pharmaceutical Services under Regulation 29 of the CDCR 1984. The Directive provides data exclusivity for new chemical entities and second indications only.

The data exclusivity period runs from the date the new drug or the second indication is first registered or granted marketing authorisation and data exclusivity or test data protection in the country of origin or any country recognised by the Director of Pharmaceutical Services. The period for which data exclusivity is granted is determined on a case-by-case basis by the Director of Pharmaceutical Services; it shall not be more than five years for a new drug product containing a new chemical entity, and three years for the second indication of a registered drug product.

Data exclusivity is not automatically conferred upon approval of a drug. The interested party must make a separate application for data exclusivity.

An application for data exclusivity can be made via a Letter of Intent in conjunction with the application for registration of a new drug product containing a new chemical entity or the application for a second indication of a registered drug product.

Various regulations and guidelines have been issued concerning the commercialisation and distribution of medicines and medical devices aimed at handling COVID-19 in Malaysia. These include the following.

• The MDA’s Guideline on Conditional Approval for COVID-19 Rapid Test Kit (Self-Test) established a temporary approval method for COVID-19 test kits to expedite the registration process of this medical device. Under this initiative, the requirement for the CAB to conduct conformity assessments on medical devices is waived. Instead, a COVID-19 Expert Committee was established to assess and evaluate the test kits to ensure their compliance with the established requirements of quality for use. The conditional approval is valid for one year and may be revoked if concerns are raised about the device’s safety and/or the applicant’s non-compliance with the requirements of the conditional approval.
• The NPRA issued the Guidance and Requirements on Conditional Registration for Pharmaceutical Products During Disaster to provide expedited access to pharmaceutical products such as vaccines during a disaster. Under this scheme, all registration applications for pharmaceutical products that fulfil the stipulated conditions will be given priority review, in which evaluation will be completed within 70 working days instead of the standard 210 working days. Products that have been conditionally approved by any DCA reference country or the WHO will be given top priority. Pursuant to this guidance, the standard requirements for the registration of pharmaceutical products have been relaxed. For instance, an application for pharmaceutical product registration may now be made for a pharmaceutical product that has not completed the Phase III clinical study.
• The DCA issued Decision NPRA.600-1/9/7(41), which exempted all registered COVID-19 vaccine products from the requirement to conduct physical tests for lot release activities. Pursuant to this decision, the requirement for the National Regulatory Authority or National Control Laboratory to evaluate an individual lot of a registered vaccine has been waived.

During the COVID-19 pandemic, the NPRA allowed sponsors to distribute investigational products directly to trial subjects without the need for site visitation or personal contact (“Direct-to-Patients”). The sponsor shall notify this arrangement to the NPRA and document each delivery in an accountability report for regulatory inspections.

The investigational product accountability report shall include a comprehensive record of the standard operation procedure for delivery, the manner of delivery, the storage requirements, the subject receiving adequate training on self-administration of the investigational products, and the employees processing the subject’s personal data.

When implementing the Direct-to-Patients option, the following must be observed:

• the sponsor holds a valid CTIL or CTX with an approved import quantity;
• the investigational products shall only be distributed from Malaysian sites to trial subjects;
• the delivery of the investigational products shall not raise any new safety risks;
• subjects understand and provide consent that the investigational products will be delivered directly to their homes;
• the sponsor has investigated the viability of alternative distribution via an investigator or hospital pharmacy; and
• the sponsor shall ensure the conduct of appropriate alternative safety monitoring if subjects are not able to come to the investigational site.

The NPRA has also issued a Special Directive to accept applications for CTX from local manufacturers to manufacture unregistered COVID-19 vaccine products for the purposes of conducting research and development in Malaysia involving First-in-Human (FIH) studies. It must be noted that the regulatory requirements for clinical trials remain applicable.

The NPRA issued Directive NPRA.600-1/9/13 (19), which grants conditional registration for COVID-19 vaccines supplied through the COVID-19 Vaccines Global Access (COVAX) Facility. The vaccine will be conditionally registered by the NPRA using the recognition mechanism that has been approved by the WHO Emergency Use Listing. The conditional registration of the vaccine under the COVAX Facility is for one year from the date the vaccine is registered and can be renewed.

The MDA issued guidelines for the importation and placing in the market of medical devices during an emergency situation through special access notification. The relevant guidelines are as follows.

• The Medical Device Guidance Document (Special Access – Notification – General Requirements) allows the MDA to issue a “no restriction letter” to an applicant for the purposes of importation and placement of the special access medical device in the Malaysian market. These medical devices are exempted from registration with the MDA and can be imported into Malaysia based on special access. The Guidance identified the following situations in which medical devices are eligible for special access:
1. when medical devices are to be used in an emergency situation that poses an immediate risk to a patient’s life or long-term health where the required medical devices are not available in Malaysia;
2. where there is an absence of alternative treatment options or where available alternative treatments failed or were deemed ineffective or unsuitable for the patient according to the medical practitioner’s clinical judgement;
3. where the medical device is needed to minimise disruption to the continued supply of a similar medical device; and
4. where the design and/or operation of a device is likely to support or enhance the outcomes of the procedure or treatment for the patient.
• The Medical Device Guidance Document (Special Access – Requirements For Ventilator During Emergency Situation) allows an applicant to import and/or sell ventilators in the Malaysian market via a “special access notification”. Pursuant to this Guidance, certain registration requirements are modified to ensure speedy approvals of such applications.
• Guideline for Registration of COVID-19 IVD Test Kits allows the MDA to grant conditional approval or special access notification to establishments to register COVID-19 test kits as medical devices.

The NPRA has introduced new guidelines to modify Good Manufacturing Practice and Good Distribution Practice inspections, to enable inspections to be carried out despite the physical restrictions caused by the COVID-19 pandemic. Instead of on-site inspection, the NPRA has implemented off-site inspection mechanisms such as remote and hybrid inspection to carry out national and foreign Good Manufacturing Practice inspections.

The Royal Malaysian Customs Department did not grant any import or export exemptions in relation to medicines or medical devices. However, the Customs Department granted an exemption from import duty and sales tax for the following:

• medical equipment, lab equipment, Personnel Protective Equipment (PPE) and COVID-19 consumables for the MOH; and
• raw materials for the manufacture of hand sanitisers such as undenatured ethyl alcohol and denatured ethyl alcohol.

The Malaysian Medical Council issued an Advisory on Virtual Consultations, which provides guidance on the provision of virtual consultations during the COVID-19 pandemic. The Advisory highlights that, while virtual consultations can only be provided in the context of an existing doctor-patient relationship, virtual consultations may also be given under limited circumstances, such as where a diagnosis can be accurately made with the patient’s history and limited audiovisual observation.

The Malaysian government has yet to exercise its right to issue compulsory licences in relation to COVID-19-related patents. Under Section 84(1) of the PA 1983, the Minister in charge may allow a government agency or third party to use the patented invention without the patent owner’s consent on the following grounds:

• if there is a national emergency or where the public interest so requires, particularly national security, nutrition, health or the development of other vital sectors of the national economy as determined by the government; or
• where a judicial or relevant authority has determined that the manner of exploitation by the owner of the patent or their licensee is anti-competitive.

No liability exemptions were issued to exclude civil liability from the use of COVID-19 vaccines or treatments.

Pursuant to the Emergency (Essential Powers) Ordinance 2021 (2021 Ordinance), the Yang di-Pertuan Agong or anyone authorised by him may take temporary possession of land, building, movable property or resources, and issue directions which appear necessary or expedient. A person who contravenes such orders is liable to a fine of up to MYR5 million or imprisonment for a period of not more than ten years, or both.

While the 2021 Ordinance allows the mandatory requisition of land and resources, there have been no documented cases of its use by authorities to acquire land, buildings, movable assets, or resources for the manufacturing of COVID-19 medicines and medical equipment.

Typically, public procurement of supplies valued above MYR500,000 are done through an open tender process. To address the urgent need of access to vaccines, the government has implemented a system of public procurement specifically for the procurement of COVID-19 vaccines in Malaysia. Accordingly, a Special Committee for Ensuring Access to COVID-19 Vaccine Supply was set up to assist with the procurement process.

Malaysia also participated in global initiatives such as the COVAX Facility and entered into bilateral agreements with countries in an effort to secure the public procurement of vaccines.