Contributed By Lee & Ko
The primary legislation governing pharmaceuticals in Korea is the Pharmaceutical Affairs Act (PAA), while the Medical Devices Act and the In-Vitro Medical Devices Act (collectively, MDA) regulate medical devices, in both cases, together with related presidential decrees and regulations and guidelines promulgated by the Office of the Prime Minister and the Ministry of Food and Drug Safety (MFDS).
The Ministry of Health and Welfare (MHW) and the MFDS (which is overseen by the MHW) are the main regulatory bodies in relation to pharmaceuticals and medical devices, and they are responsible for issuing and enforcing most of the regulations, guidelines and administrative orders for pharmaceuticals and medical devices. Local governments (such as the Seoul Metropolitan government) also monitor pharmaceutical and medical device entities within their jurisdiction.
Administrative orders issued by the MFDS, MHW or local governments to entities in violation of the PAA or MDA may be challenged via an administrative appeal to the competent administrative appeals commission under the Administrative Appeals Act, or via administrative litigation to the competent court under the Administrative Litigation Act. In most cases, either action will request that the competent commission or court revoke or declare null the administrative order. Rulings rendered by an administrative appeal commission may also be appealed to the competent court.
In general, these challenge procedures are applicable to other regulated products, such as food products.
Pharmaceuticals are categorised into over-the-counter (OTC) drugs and prescription drugs. In principle, all pharmaceuticals must be delivered to patients by licensed pharmacists at pharmacies, except in some cases such as delivery of pharmaceuticals to patients by doctors within medical institutions. While prescription drugs require a prescription from physicians, OTC drugs can be supplied to consumers without a prescription. Additionally, the MHW has designated certain OTC drugs as emergency drugs to treat light symptoms in urgent situations at patients’ discretion, and such OTC drugs may be sold at 24-hour convenience stores by non-pharmacists after such stores’ registration with the local government.
Medical devices are classified into Classes I to IV, based on their intended use and the risk level associated with the device. Class I devices present the lowest risk, while Class IV devices are considered the highest risk and are subject to the greatest scrutiny. While medical devices may only be marketed after obtaining the relevant licence from the MFDS, certain types of medical devices designated under the MDA can be sold without such a licence. For example, glucometers that are included in, or combined with, mobile phones or household appliances, condoms, personal pregnancy diagnosis kits, and electronic thermometers can be sold without a marketing licence.
The PAA, the MDA, the Bioethics and Safety Act (BSA) and relevant regulations govern clinical trials of medicinal products and medical devices, and the MFDS oversees approval for clinical trials.
To conduct a clinical trial, the relevant clinical trial protocol must be reviewed and approved by an institutional review board (IRB) of the MFDS. The materials required to be submitted by the sponsor for clinical trial approval include the following:
Once approved, clinical trials must be conducted in accordance with the protocol and standards regarding good clinical practice for medicinal products and medical devices, as applicable.
All clinical trials are registered with the MFDS. Basic information regarding clinical trials such as sponsor information, information on the clinical trial including its title, purpose and use, information of drug used, plan for clinical trial, method to arrange the participants subject to experimental group or control group, the status of the clinical trial (eg, on-going, completed), method to administer and evaluate the clinical test (eg, primary and secondary end point), and subject inclusion and exclusion criteria can be searched at the medicinal products comprehensive information system, which is a website of the MFDS (www.mfds.go.kr/eng/index.do).
No restriction exists on using online tools to support clinical trials. However, it is generally required that clinical trials are to be conducted by doctors or hospitals with in-person interviews, and written informed consents from clinical trial subjects. Recruitment of clinical trial subjects can be conducted online.
The protocols allowing provisional “untact” medical care (a term coined by a research team in Korea for non-face-to-face contact) under Article 49-3 of Infectious Disease Control and Prevention Act may apply to clinical trials, whereby the treatment for, and monitoring of, patients during clinical tests may be changed into untact treatment and monitoring.
The data from the clinical trials is considered as personal and sensitive data and the institutions conducting clinical trials are subject to the Personal Information Protection Act (PIPA) for handling and protecting information such as collection, use, provision, etc, of personal information. In addition, unless permitted to directly access the personal information, information with respect to the participant’s identity or sponsor’s intellectual property, etc, shall not be disclosed to third parties. Further, in order to protect the clinical trial subjects’ identity, unique identity numbers need to be assigned to subjects instead of their name.
When obtaining consent on the clinical trial from its subjects, the medical institution conducting the clinical trial must explain that the records of subjects’ personal information will be kept confidential, stipulate the same in writing, and make it clear that such personal information shall be maintained confidential even if results of the clinical trial become publicly available. It further needs to inform that the records relating to clinical trial including the subjects’ medical record can be accessed by the sponsor’s monitoring agent or inspector through an institutional review board (IRB) of the medical institution above, and that the MFDS may also access and review such information and relevant materials.
In addition to the requirements described in 2.5 Use of Data Resulting From the Clinical Trials, according to clinical trial management standards, such database needs to have a security system which prevents unauthorised persons from accessing the information, and matters as prescribed by the chief of MFDS for proper management of electronic records must be complied with. The sponsor also has to use identifier code for clinical trial subjects.
Under Article 2 of the PAA, “drugs” are defined as those other than quasi-drugs, among the articles listed in the Korean Pharmacopoeia, or articles, other than appliances, machinery or equipment, used for the purposes of diagnosis, treatment, alleviation, care or prevention of diseases of human beings or animals, or used for the purpose of exerting pharmacological effects upon the structure or functions of humans or animals.
A “medical device” is defined under the MDA as an instrument, machine, apparatus, material, software or any other similar product specified in the following:
Sometimes, it is difficult to distinguish medical devices from personal healthcare products even when considering the purpose of use and the risk to the human body. In such case, guidance or administrative interpretation from the MFDS may be requested.
To market biological drugs in Korea, the initial marketer is required to obtain marketing approval, the same as that for chemical drugs. Key factors to consider when reviewing an application for market approval are:
For some biologics such as the botulinum toxin, additional strict requirements on use, transfer, etc, apply. Meanwhile, unlike generic drugs, a bioequivalence test does not replace data on stability and efficacy in order to obtain market approval for biosimilars.
Under the PAA, market approval for pharmaceuticals is valid for five years, and renewal is required after five years. For renewal, safety data, domestic manufacturing/import data, and a GMP compliance certificate must be submitted to the MFDS at least six months before the expiration date. If the market approval holder does not file the application for renewal or fail to meet the requirements, the market approval is cancelled.
In the case of medical devices, no renewal system existed previously, but since 8 October 2020, market approval for medical devices is to be valid for five years from the market approval date. Similar to pharmaceuticals, for medical devices, data proving that safety and efficacy has continued to be the same since market approval was initially granted, and data on production/import performance, etc, must be submitted for renewal at least 180 days before the expiration date.
Data proving safety and efficacy, such as clinical trial results, must be submitted to the MFDS for obtaining market approval. In some cases such as generic drugs or incrementally modified drugs, however, safety and efficacy data can be replaced with bioequivalence test result data.
The procedure for assessing market approval on medical devices varies depending on the risk they pose to human bodies. In the case of high-risk medical devices (Class III/IV), higher level of scrutiny will apply such as requesting and reviewing more data, including clinical data proving the efficacy and safety, compared to low-risk medical devices (Class I/II) where various data such as clinical trial data is exempted.
In the event that the indications for drugs or medical devices are changed after market approval, it is possible to file an approval for change, and the procedure is similar to the procedure for new market approval.
It is also possible to transfer a market approval from one market approval holder to another.
In Korea, even if no market approval has been obtained, investigational drugs can, after relevant clinical trials are implemented and approved, be used as part of a compassionate use programme. The compassionate use programme is permitted only in cases where a patient has:
In addition, certain orphan drugs and drugs for the treatment of rare diseases which are directly imported and distributed by the Korea Orphan & Essential Drug Center (KOEDC), and drugs which MFDS admitted for urgent introduction for treatment of patients following MFDS or MOHW’s request are exempted from obtaining import approval.
Pharmaceuticals and medical devices are subject to PMS during the following re-examination periods, starting from the date of issuance of the market approval:
Approved pharmaceuticals or medical devices may be subject to re-evaluation if the MFDS finds it necessary to re-evaluate the safety and efficacy of approved pharmaceuticals or a medical device. To re-evaluate, the MFDS reviews not only documents and materials submitted before the market approval, but other post-approval information, including side-effect data since the launch, status in other countries and amendments to the approval made in relation to safety and efficacy.
Under the PAA and MDA, if a sponsor filed an application request in writing to protect information or data contained therein against disclosure, such information or data should not be disclosed unless otherwise required by the public interest. The PAA and MDA even impose criminal penalties for breaching the non-disclosure obligation above.
Further, the Korean Criminal Act (KCA) punishes a public official or former public official who divulges official secrets obtained in the course of performing their duties.
While the contents contained in the application is not disclosed, third parties may infer from the following circumstances that certain applications for market approval might be granted shortly:
A person who sells pharmaceuticals or medical devices without market approval shall be punished by imprisonment for not more than five years or by a fine not exceeding KRW50 million. Also, the MFDS may suspend the manufacturing business for six months as an administrative sanction.
It should be noted that, unlike criminal punishment, an administrative sanction can be imposed regardless of a violator’s intent.
The PAA and MDA have no regulation on the importation or exportation of counterfeit pharmaceuticals and medical devices.
However, the Korea Customs Service (KCS) should notify the owner of IP rights when discovering suspected counterfeits of the medical devices or pharmaceuticals which are protected by valid IP rights. Upon notification, the right-holder can request the KCS not to provide customs clearance to such counterfeits.
A manufacturing plant of pharmaceutical products is subject to an authorisation for manufacturing pharmaceuticals under the PAA, and a manufacturing plant of medical devices needs an authorisation for manufacturing medical devices under the MDA. The MFDS grants such authorisation. When a person, who intends to manufacture pharmaceuticals or medical devices, prepares and files the application for manufacturing authorisation and necessary documents with the local district of MFDS to which the manufacturer belongs, such local district of MFDS reviews whether the applicant for manufacturing approval (in the case of a company, the representative) is qualified and whether all necessary documents are satisfied, and if appropriate, it grants authorisation. Once authorisation is granted, it will be valid without any other special renewal procedure unless grounds for revocation occur under the PAA or the MDA.
Wholesale of pharmaceuticals is subject to an authorisation from the head of Si/Gun/Gu (ie, the local government) in Korea. To obtain such authorisation, the applicant should meet qualifications and have a business place, warehouse and other facilities as prescribed by Presidential Decree of the PAA. The authorised wholesaler is in principle required to employ a pharmacist to manage the relevant tasks. Such authorised wholesaler can sell or acquire pharmaceuticals for sales purposes which comply with the standards for quality management of pharmaceuticals in distribution. There is no validity period for the authorisation of wholesale of pharmaceuticals.
For the wholesale of medical devices, the wholesaler should file a notification of distribution with the competent Special Self-Governing Mayor, Special Self-Governing Province Governor, or the head of a Si/Gun/Gu. Once such notification of distribution is accepted, the person can distribute medical devices and there is no period of validity for wholesale notification.
Pharmaceuticals are classified into OTC drugs and prescription drugs under the PAA.
OTC drugs refer to any of the following drugs, which meet the standards determined and publicly notified by the Minister of Food and Drug Safety, following consultations with the Minister of Health and Welfare:
Emergency drugs among the OTC drugs are used mainly for minor symptoms at the sole discretion of patients, and are publicly notified and prescribed by the Minister of Health and Welfare. Such emergency drugs can be purchased at places other than pharmacies. Conversely, prescription drugs mean drugs which are not OTC drugs and require a physician’s prescription.
Meanwhile, orphan drugs mean either drugs used for the purposes of diagnosis or treatment of rare diseases under the Rare Disease Management Act or drugs with rare subject of application, whose alternative drug does not exist or whose safety or efficacy has been significantly improved compared to its alternative drug, which are designated by the Minister of Food and Drug Safety.
Other than the above, drugs essential for health and medical treatment, whose stable supply is difficult only as a result of the market function, are designated and managed as national essential drugs.
The PAA and MDA are the primary laws governing the import and export of pharmaceuticals and medical devices, while the Customs Act and Integrated Public Announcement promulgated by the Ministry of Trade, Industry and Energy (MOTIE) pursuant to the Foreign Trade Act, apply the requirements of the PAA and MDA to the actual customs procedure.
In principle, pharmaceuticals and medical devices manufactured abroad are subject to the same regulations as those manufactured domestically. The importers of such products are responsible for obtaining the necessary licences from the MFDS, such as import business licences and import authorisations for particular products, and complying with all obligations under the PAA or MDA, such as quality testing.
A manufacturing business licence and manufacturing authorisations for particular products are required for the manufacture of pharmaceuticals or medical devices, whether for domestic use or export. However, manufacturing authorisations for pharmaceuticals or medical devices that are only exported, and not sold or distributed domestically, are exempted from certain requirements and do not require renewal.
The MFDS regulates licences and authorisations for both pharmaceuticals and medical devices, while the Korean Customs Service enforces the relevant regulations at the point of entry for imports.
Only those with an import business licence from the MFDS for pharmaceuticals or medical devices can act as their importer of record.
In order to receive an import business licence for either pharmaceuticals or medical devices, the entity applying for the licence must fulfil certain requirements, such as having the required storage facilities, quality testing facilities and equipment, and personnel such as import managers and safety managers. Additionally, local presence is required in order to hold an import business licence for pharmaceuticals and medical devices.
In principle, only entities with an import business licence and import authorisation for the particular imported product can import pharmaceuticals or medical devices into Korea.
Exceptions of varying degrees to this rule include imports for the treatment of rare diseases, emergency use, clinical trials, research and testing, and personal use.
The Customs Act requires those who import products required by law to have approval, licence, labelling or fulfil other requirements for their importation to show proof of the fulfilment of such conditions to the head of the competent customs office, which for pharmaceuticals and medical devices are the requirements imposed by either the PAA (for pharmaceuticals) or the MDA (for medical devices), see 6.1 Governing Law for the Importation and Exportation of Pharmaceutical Devices and Relevant Enforcement Bodies to 6.3 Prior Authorisations for the Importation of Pharmaceuticals and Medical Devices.
Whether the imported product is subject to the regulations and requirements of either the PAA or MDA would be determined by whether the product satisfies the criteria for pharmaceuticals or medical devices as defined in the respective acts.
As of February 2023, Korea has entered into 21 economic partnership agreements and free trade agreements with other countries, all 21 of which (the RCEP and FTAs with Chile, Singapore, EFTA, ASEAN, India, the European Union, Peru, the United States, Türkiye, Australia, Canada, China, New Zealand, Vietnam, Colombia, MERCOSUR, the United Kingdom, Israel, Cambodia and Indonesia) are in force.
In Korea, the price of pharmaceuticals and medical devices controlled by the government is consumer (ie, patient) prices (including 10% VAT), and the margin will be set according to each company’s policies. The government’s price control for pharmaceuticals is based on the relevant laws such as the National Health Insurance Act (NHIA), the Rules on the Standards of National Health Insurance Medical Benefits, and the Standards for Decision or Adjustment on Drugs. Also, the government’s price control for medical devices is in accordance with NHIA, the Rules on the Standards of National Health Insurance Medical Benefits, and the Standards for Decision or Adjustment on Activity and Medical Materials for Treatment, etc. The MOHW, HIRA and national healthcare insurance system (NHIS) control the price of pharmaceuticals and medical devices.
Prices for the majority of medical services provided and pharmaceuticals sold in Korea are reimbursed by the Korean NHIS, and the substantial majority of legal residents of Korean are insured by NHIS. If a medical service or a pharmaceutical product is covered by NHIS, a patient cannot be charged more than the co-payment amount corresponding to the maximum reimbursement price published by the MOHW. If a medical service or pharmaceutical is not covered by NHIS, the healthcare provider is free to determine the price of such product or service.
In the context of medical device covered by NHIS, the medical device may be subject to its own maximum reimbursement price or the cost of the medical device may be included in the maximum reimbursement price for the relevant medical service utilising such device.
In order for pharmaceuticals and medical services to be reimbursed, a decision for reimbursement is required and the HIRA and MOHW decide whether to reimburse the cost for the medical services or pharmaceuticals and their costs, through the evaluation of clinical efficacy, cost effectiveness, etc.
For drugs, foreign prices may be referenced in the negotiation of drug price and upper limit of reimbursement. However, the economic evaluation for pharmaceuticals takes precedence over such external price referencing in determining the price of drugs. Foreign prices have direct effect only when deciding the price of drugs whose economic evaluation can be omitted.
Meanwhile, in the case of pricing of medical devices, foreign prices are not referenced but the import price or the price of listed products with similar function are considered.
A substantial part of the costs of pharmaceuticals and medical services (using medical devices) is covered by the health insurance scheme. However, even when covered by the health insurance scheme, the full amount is not paid by the health insurance, as the patient is responsible for the applicable co-pay amount.
There is a difference in the way pharmaceuticals and medical services are covered by health insurance. In the case of pharmaceuticals, products not listed on the reimbursement list are not covered by health insurance (positive-list way), however, in the case of medical services, the MOHW stipulates medical services not covered by health insurance (negative-list way).
As for drugs, it is the principle of a positive list system to determine the eligibility for reimbursement and reimbursement amount on the basis of HTA (health technology assessment – ie, cost-utility analysis). In the case of pharmaceuticals for treatment of cancer or orphan diseases, however, economic evaluation may be omitted.
Meanwhile, for medical devices, the HTA would play a minor role only to a limited extent in determining the eligibility for reimbursement and reimbursement amount.
After the separation of prescribing and dispensing in 2000, only physicians can prescribe drugs in hospitals, and only pharmacists can dispense drugs in pharmacies (this applies to the case of outpatient only, and dispensing drugs in pharmacies within the hospital is possible for inpatients). In order to prevent the over prescription of narcotic or psychotropic drugs such as propofol, monitoring of prescription details is performed through HIRA’s big data management system.
There are no specific rules which regulate medical apps only. However, a medical app may be treated as a medical device if the medical app satisfies requirements for medical devices as prescribed by the MDA. That is, in case that a medical app is used for the purpose of diagnosing, curing, alleviating, treating or preventing a disease, it may be treated as a medical device under Article 2 of the MDA. If it is not used for the purpose above, however, it would not fall under the definition of a medical device.
In principle, the MSA does not allow telemedicine between physician and patient. However, due to the COVID-19 pandemic, the Korean government is temporarily allowing limited telemedicine. According to the public notice of the MHW, doctors can consult with patients via phone and remote prescriptions for the time being when they believe safety is secured, but discussions on to what extent such cases should be allowed is ongoing.
The Fair Labelling and Advertising Act (FLAA) applies to advertising of all products including pharmaceuticals and medical devices. Also, product advertising on an online portal, company webpage, social network, etc, will be subject to “Evaluation Protocols on Online Advertising”, the regulation of the Korean Fair Trade Commission (KFTC).
The advertising and promotion of pharmaceuticals are also regulated by the PAA and supervised by the MFDS. Further, advertising and promotion of medical devices are regulated by the MDA, and online advertising of medical devices via online portal, company webpage, social network, etc, are required to receive an in-advance review of voluntary review institution under the MDA.
Electronic prescriptions with digital signatures prescribed by physicians or dentists are regulated under Article 17-2 of the MSA. However, as there is no officially authorised system which transfers electronic prescription data from a medical institution to a pharmacy, filling prescriptions via electronic prescription is not currently implemented. At the moment, MOHW is reviewing the introduction of an official electronic prescription transfer system.
Online sales of medicines are not permitted under the PAA. Conversely, medical devices can be sold by a person who notified such distribution to the mayor or governor of local government in the area where his or her business place is located. However, as for some products designated under Article 38 of Enforcement Rules of the MSA such as a thermometer, electronic automatic tonometer, etc, online sales are possible without notification of distribution of medical devices.
Electronic health records contain extensive information on a patient’s health. The PIPA considers such information sensitive data and therefore imposes strict regulation by preventing any use without consent from patients in principle. Having stated that, the PIPA stipulates that in the case of pseudonymisation of sensitive data, such data could be processed without the consent of data subjects for statistical, scientific research purposes, etc. However, discussions are ongoing on whether using pseudonymised electronic records without patients’ consent would violate the MSA.
Meanwhile, if medical institutions satisfy the standards as set forth in “Guidelines for Facilities and Equipment Necessary for Managing and Keeping Electronic Medical Records” as published by MHW, they can store and keep such electronic medical records (EMR) in an outside system. Accordingly, in the event that medical institutions meet technical standards as prescribed by the above Guidelines (eg, network and system security equipment and backup storage device), they can transmit EMR of patients to a cloud platform for storage.
The PAA and the Patent Act (PA) are the main laws governing patents on pharmaceuticals and medical devices in Korea. Every patent is subject to the PA. The main legal issues regarding patents on pharmaceuticals and medical devices are patent application and registration, patent validity and term as well as invalidation actions and lawsuits.
Meanwhile, Korea implements the Drug Approval-Patent Linkage programme, and the PAA regulates the programme.
There are no patentability requirements that are specific to pharmaceuticals or medical devices, and general patentability requirements still apply.
It is possible to obtain an improvement patent in Korea for novel medical uses, dosage regimes and selected patient populations. For this, the novel medical uses, dosage regimes or selected patient populations must be specifically described in the claim of the patent while satisfying the general requirements of novelty and inventiveness. In addition, experimental results supporting the effects of the drug, such as pharmacological data or some form of specific information that can substitute such experimental results, must be described in the patent specification.
The act of selling such patented pharmaceuticals labelled with the registered medical uses, dosage regimes or selected patient population without permission from the patent owner constitutes patent infringement.
Korea implements a system where the patent term for pharmaceuticals may be extended by up to five years for periods that meet certain requirements in the drug approval process during which the patent inevitably could not be practiced. Specifically, in the case of a pharmaceutical manufactured with a novel active substance as its active ingredient which has received market approval for the first time in Korea, a term extension equal to the sum of the period elapsed for clinical trials and review by MFDS may be granted a single time.
An application for patent term extension must be filed with the Korean Intellectual Property Office (KIPO) within three months from the date of market approval, and the application must be made under the name of all co-owners when it is jointly owned. A third party may file a lawsuit seeking the revocation of the patent term extension.
Patent infringement on pharmaceuticals or medical devices occurs when a patent is practised without the consent of the patent owner. A patent is practised when a pharmaceutical or a medical device is manufactured, sold, used, leased, imported or offered for sale. In Korea, applying for market approval itself does not constitute patent infringement. It is possible to file a lawsuit based on the threat of infringement even if actual infringement has yet to materialise. The party claiming the threat of infringement should establish that there is a “likelihood of infringement” by a third party. A decision ordering product disposal and facility removal can be obtained.
Patent infringement is not found for:
The Korean government can grant to itself or third parties compulsory licences on patents whose non-commercial practice is necessitated for public good during times of emergency or crises. Upon the decision by the chief of KIPO, compulsory licences can be granted to third parties in the following cases:
The patent owner or the exclusive licensee can seek a compensation of damages and an injunction by filing an infringement lawsuit. A preliminary injunction can be separately filed to expeditiously prevent the infringing product from entering the market by way of product disposal and facility removal. It is typical for the party accused of patent infringement to defend its action by filing a patent invalidation action or lawsuit. There are multiple cases in which the patent owner and the exclusive licensee file the patent infringement lawsuit and request a preliminary injunction at the same time.
The PAA provides that the generic entrant should declare its position on the patent of the original that is listed on the drug patent list on which the MFDS registers and maintains patents on drugs. In other words, the generic entrant should specify whether it plans to enter the market after the expiration of the patent term, obtain a grant of licence or challenge the validity of the patent. The generic entrant should establish that it has notified the patent owner of such declaration to obtain market approval.
The owner of valid intellectual property rights on pharmaceuticals or medical devices can make both civil (request for injunction and compensation of damages) and criminal claims against the manufacturer or seller of the counterfeits. Moreover, the Korea Customs Service should notify the owner of IP rights if its agents discover suspected counterfeits. Upon notification, the right-holder can request that such counterfeits do not receive customs clearance.
The Trademark Act provides that a trade mark which indicates, in a common manner, the quality, efficacy or usage of the product, lacks distinctiveness and thus cannot be registered. The provision also applies to pharmaceuticals and medical devices. In addition, for pharmaceuticals and medical devices, it is not permitted to register as a trade mark a brand name that is widely known among consumers.
In the case of parallel importation of authentic goods, whether such importation is allowed varies among cases. If the owner of the Korean trade mark and the foreign trade mark is the same, products distributed overseas can also be sold locally. However, if such is not the case, the importation and local sale of the products that were distributed overseas is prohibited under the principle of territoriality.
Like other products, pharmaceuticals and medical devices can receive IP protection under trade dress or design. The Unfair Competition Prevention and Trade Secret Protection Act (UCPA) provides for trade dress rights, whereas the Design Act provides for design rights.
In Korea, data exclusivity is protected during the period for post-marketing surveillance (PMS). PMS periods vary depending on the types of pharmaceuticals:
Korea does not make a distinction between chemical drugs and biologics when it comes to data exclusivity.
In order to effectively respond to pandemic issues such as COVID-19, the Special Act for the Promotion of Development and Emergency Supply of Medical Products to Respond to Public Health Crisis was both enacted and implemented on 9 March 2021. In the case of pharmaceuticals and medical devices designated as public health emergency response medical products:
The MFDS had published its clinical trial follow-up policy for 2021. According to the policy, in consideration of the difficulties in visiting hospitals due to the spread of COVID-19, it was announced that phone counselling and prescriptions, proxy prescriptions and drug delivery to trial participants would be temporarily permitted during the clinical trials. In addition, the MFDS published guidelines titled “Considerations for Development of a COVID-19 Treatment” (14 April 2021) and “Considerations for Development of a COVID-19 Vaccine” (15 June 2021) detailing the pre-clinical and clinical trial requirements for market authorisation of COVID-19 treatments and vaccines.
Based on the Special Act for the Promotion of Development and Emergency Supply of Medical Products to Respond to Public Health Crisis, emergency approvals for the use of pharmaceuticals or medical devices can be granted if it is deemed necessary for appropriately responding to public health emergency or if there is a request from the chiefs of the relevant authorities in the central government. In the case of pharmaceuticals or medical devices that received emergency approval, it is possible to supply them either through importation or manufacture without obtaining market approval.
The MFDS officials have traditionally been required to conduct an on-site inspection on overseas manufacturing plants for pharmaceuticals and medical devices. As a result of COVID-19, since 2020, the MFDS implemented a policy of document reviews rather than on-site inspections. However, it announced the plan to resume the on-site inspection on overseas manufacturing plants in 2023 as Korea and most of the other countries are phasing out of COVID-19.
There are no restrictions or flexibilities concerning import/export procedures that have been introduced in relation to medicines or medical devices due to COVID-19, other than the special provision on authorisation for importation explained in 11.1 Special Regulation for Commercialisation and Distribution of Medicines and Medical Devices and 11.3 Emergency Approvals of Pharmaceuticals and Medical Devices.
Under the PAA, telemedicine between the doctor and the patient is not allowed in principle. However, around March 2020, the MOHW made a public notice titled “Measures on Temporarily Allowing Phone Counselling, Prescription and Proxy Prescription”. Pursuant to the public notice, telemedicine, drug prescription and courier delivery of drugs are temporarily allowed and continue to be implemented to this date.
Around December 2021, the National Assembly proposed an amendment to the Patent Act, which allows compulsory licences in cases of national emergency or extreme emergency if non-commercial practice of patents is necessary for public good. However, the amendment was not passed. There is no other announcement by the Korean government on compulsory licences.
There are no liability exemptions introduced to existing or new provisions in connection with COVID-19 vaccines or treatments.
There are no new provisions introduced, nor existing ones used, to allow the requisition or conversion of manufacturing sites due to COVID-19.
There are no notable changes to the system of public procurement of medicines and medical devices due to COVID-19.