Contributed By Kasznar Leonardos Intellectual Property
Pharmaceuticals and medical devices in Brazil are regulated by Federal Laws and Resolutions (known as Resoluções or RDCs) issued by ANVISA, the National Health Regulatory Agency.
Key legislation for pharmaceuticals includes:
Key legislation for medical devices includes:
ANVISA operates independently within the Ministry of Health as the primary regulatory authority. It oversees the production, marketing and utilisation of health-related products and services, as well as supervising ports, airports and borders. ANVISA functions as a semi-autonomous agency, with administrative and financial autonomy but linked to the federal government (Ministry of Health). Oversight and budgetary control are provided by the Ministry, while ANVISA’s board of directors, composed of technical experts, makes science-based decisions regarding regulations and approvals.
Regulatory decisions in the pharmaceutical and medical field can be contested through administrative appeals, either directly to the relevant regulatory authority or via lawsuits in federal courts.
The process for filing administrative appeals against ANVISA’s decisions is governed by Law 9,784/1999, which regulates administrative procedures within the Federal Public Administration, and RDC 266/2019. ANVISA’s decisions undergo a maximum of three instances:
First instance appeals are directed against decisions issued by ANVISA’s Organisational Units and must be addressed to the authority responsible. If unresolved initially, appeals are reviewed by the General Appeals Management at the second stage and, if necessary, escalated to the Appeals Division (GGREC) and ultimately to the Collegiate Board of Directors (DICOL).
Appeals must adhere to formal requirements outlined in RDC 266/2019, Article 4 onwards, and must be submitted in writing. The deadline for appealing an ANVISA decision is 30 days from the notification date.
Similar challenges can be applied to other regulatory matters under ANVISA’s jurisdiction, such as food, cosmetics, sanitisers and tobacco derivatives.
ANVISA categorises pharmaceutical products based on their active pharmaceutical ingredient (API) and innovative characteristics as outlined in RDC 753/2022, amended by RDC 948/2024, as can be seen below:
Pharmaceutical Categorisation (RDC 753/2022)
Primarily, but not exclusively:
Medical Device Categorisation (RDC 751/2022 - amended by RDC 777/2023 and 810/2023)
Categorised by use and risk:
Risk Classification
Clinical Trials for Pharmaceuticals
Clinical Trials for Medical Devices
Pharmaceuticals
For ANVISA approval of pharmaceutical trials, sponsors must submit a Drug Clinical Development Dossier (DDCM) as per RDC 945/2024. ANVISA’s Co-Ordination of Research and Clinical Trials department (COPEC) assesses the DDCM for sanitary risks before approval. ANVISA aims to complete its analysis within 90 days. Sponsors must also provide detailed protocols to the Research Ethics Committee (CEP) before trials commence. Imported products for human research must also obtain ANVISA approval, with sponsors maintaining responsibility for data integrity and quality, even if functions are delegated to a Clinical Research Organisation (CRO).
It is worth noting that Law 14,874/2024 establishes a new deadline of 90 days for ANVISA’s analysis of primary petitions for clinical trials with human beings.
Medical Devices
RDC 837/2023 simplified medical device clinical trials in Brazil, aligning with international standards and clarifying ANVISA approval requirements. This regulation eliminates the need for Clinical Research Process Consent and expedites approvals by consolidating documentation under a single Medical Devices Clinical Research Dossier (DICD) process. This streamlining removes the necessity for CEP opinions, simplifying paperwork. Only trials with results that could support Class III and IV medical device registration in Brazil necessitate ANVISA submission.
ReBEC (Registro Brasileiro de Ensaios Clínicos) is the official Brazilian Registry of Clinical Trials, operated by ANVISA. It is a public platform where anyone can find details about clinical trials conducted in Brazil, including study design, participant criteria and contact information.
The database contains information such as trial title, sponsor, investigational product, phase, primary and secondary endpoints, inclusion/exclusion criteria and participating research centres.
Health data is considered sensitive under National Research Ethics Committee (CONEP) Resolution 466/2012 and Law 13,709/2018, also known as the General Data Protection Law (Lei Geral de Proteção de Dados Pessoais or LGPD), mandating confidentiality for trial participants’ data in both public and private institutions.
Sponsors must document and report adverse events, especially fatal or life-threatening ones, to ANVISA electronically within seven days of becoming aware of them (RDC 945/2024).
Section II, subsections I and II of RDC 945/2024, specify that sponsors must submit annual monitoring reports on the trial drug’s progress, detailing all adverse events using subject codes. They also require a final report after the trial’s completion across all participating countries, including information on withdrawn subjects and verified adverse events.
These reports must meet the minimum requirements outlined in Article 73 for annual reports and Article 74 for final reports. The annual report should be submitted within 60 days of the annual reference date (the trial’s start date in Brazil), while the final report is due within 12 months of the trial’s conclusion.
Law 14,874/2024 also establishes that the researcher is responsible for submitting the research documentation, including any amendments, to the CEP for approval, but the reporting of adverse events continues to be ANVISA’s responsibility.
There are no specific regulations in Brazil that explicitly restrict the use of online tools for supporting clinical trials, such as for recruitment or monitoring purposes.
However, it is essential to ensure that any online tools used comply with CONEP Resolution 466/2012 and the LGPD, which clearly states that health data is considered sensitive, and confidentiality of trial participants’ data is mandatory for both private and public institutions.
Building on the discussion above, health data is considered sensitive, necessitating strict confidentiality safeguards in both private and public institutions. According to Article 5, Item II of the LGPD, sensitive personal information includes details regarding a natural person’s racial or ethnic origin, religious beliefs, political views, union or other organisational memberships, health or sex life, and genetic or biometric data.
Transferring personal data from clinical trials to a third party or affiliate is possible but subject to stricter conditions outlined in Article 11 of the LGPD.
Following on from 2.5 Use of Data Resulting From Clinical Trials, data from clinical trials in Brazil faces strict data protection regulations due to its personal and sensitive nature. Before transferring such data to third parties or affiliates, explicit consent from participants, contractual agreements outlining data security protocols and potential data residency restrictions must all be considered.
Article 4 of RDC 751/2022 (in force but amended by RDCs 777/2023 and 810/2023) regulates the classification of medical devices as any instrument, apparatus, equipment, implant, in vitro diagnostic medical device, software, material or other article, intended by the manufacturer to be used, alone or in combination, in human beings, for some specific medical purpose, and whose principal intended action is not achieved by pharmacological, immunological or metabolic means in the human body, but which may be aided in its intended action.
For a product to be classified as a pharmaceutical (regarding Law 10,742/2003), it should be any pharmaceutical product, technically obtained or prepared, for prophylactic, curative, palliative or diagnostic purposes.
Biologic products often involve complex manufacturing processes and unique safety considerations compared to traditional chemical drugs. Therefore, obtaining marketing authorisation for biologics in Brazil typically involves additional requirements beyond those for chemical drugs.
Comprehensive Dossier
Detailed information about the biologic product must be submitted to ANVISA. This dossier typically includes:
Comparability Studies
For biosimilars (biologics that are similar to an already approved reference product), additional comparability studies demonstrating similarity to the reference product in terms of quality, safety and efficacy are often required.
Stricter Regulatory Requirements
Compared to chemical drugs, biologics might face stricter regulatory requirements related to manufacturing process controls, product characterisation and ongoing monitoring of safety post-marketing.
Additional Considerations
The following are some of the main resolutions that relate to biological products.
Marketing authorisations for pharmaceuticals and medical devices are valid for ten years from the date of their publication in the Brazilian Official Gazette (DOU). They can be renewed for successive ten-year periods.
Certain requirements must be met for renewal, for example, for medicines, the product must have been marketed for at least 80 months (two-thirds) of the ten-year period (120 months).
For medical devices, for example, revalidation of the registration must be requested no more than 12 months and no less than six months before the registration expires.
The registration of a product which is subject to health surveillance may be cancelled in the following situations.
In addition, ANVISA can take preventive measures to protect public health during a health risk assessment. These measures, authorised by Law 6,360/1976, Law 9,782/1999 and Law 9,784/1999, include inspection actions such as seizure, recall, prohibition and suspension of activities relating to the product or service in question (storage, marketing, distribution, manufacture, import, advertising and/or use).
Furthermore, ANVISA can utilise precautionary measures, which are also proactive administrative actions based on the terms of Law 6,437/1977. These measures aim to safeguard public health in situations of imminent risk, even before a formal hearing with the party involved. For example, a precautionary interdiction can be applied when there is clear evidence of product alteration or adulteration.
Once a health investigation is completed and an infraction is confirmed, ANVISA initiates the process of charging the responsible party. Penalties for sanitary infractions, as defined in Law 6,437/1977, can be applied individually or in combination.
The process for obtaining marketing authorisation for pharmaceuticals and medical devices in Brazil is overseen by ANVISA.
What follows is a summary of the steps.
Variations to marketing authorisation:
Transfer of marketing authorisation:
Steps for submitting a registration transfer request:
Important points:
In Brazil, patient access to pharmaceuticals and medical devices typically requires ANVISA’s marketing authorisation. However, exceptions exist.
Compassionate use is not guaranteed, and ANVISA holds final approval authority.
The regulations concerning the obligation on the marketing authorisation for pharmaceuticals and medical devices are summarised below.
Pharmaceuticals (Medicinal Products)
Marketing authorisation (MA) process
Pharmacovigilance obligations (medicinal products)
RDC 658/2022 establishes General Guidelines for Good Manufacturing Practices for Medicines.
Post-marketing obligations
Phase IV trials may be imposed to monitor real-world safety and efficacy.
Medical Devices
RDC 751/2022 (in force but amended by RDC 777/2023 and 810/2023) regulates the risk classification, notification and registration regimes, labelling requirements and instructions for use of medical devices.
The following are some resolutions regarding the control, inspection and monitoring of products and services:
In the realm of third-party access to pharmaceutical and medical device authorisations, regulation is governed by the Information Access Law (Law 12,527/2011). Despite the sensitivity and confidentiality of health products, interested third parties can request access to registration information under this Law.
Article 7 states that access to information includes obtaining data from records or documents produced by relevant bodies or entities, whether stored publicly or not, as well as information concerning public asset administration, resource usage, bidding and administrative contracts.
However, it is important to note that while all information regarding a registered health product may be requested, it may not always be provided by regulatory agencies such as ANVISA or the Chamber for the Regulation of the Medical Market (CMED).
The primary regulation safeguarding commercially confidential and individual-related information is the “secrecy law” (Lei do Sigilo). Additionally, trade secrets benefit from specific legislation protection, crucial for preserving proprietary knowledge and fostering competitiveness and innovation.
To safeguard trade secrets effectively, companies should implement practical measures:
In Brazil, the regulatory framework foresees routes for expediting the registration of medicines and medical devices. The optimisation of the registration proceedings has recently been enhanced by new rules regarding regulatory reliance enacted between 2022 and 2024. Additionally, for medical devices, the issuance of authorisations can be faster for products classified as Group 1 or 2 based on their risk level.
Pursuant RDC 751/2022, the category of medical devices is divided into four groups.
Regarding importation, there is a distinction between registered and notified medical devices. Imported medical devices subject to registration require the submission of proof of registration, a certificate of free sale or equivalent document, issued by the competent authority of the country of manufacture and sale, as well as a declaration from the legal manufacturer. On the other hand, notified medical devices only require the declaration issued by the legal manufacturer.
Finally, it is important to point out that in vitro medical devices have their own specific regulations, as set out in RDCs 830/2023 and 848/2024. Although they follow the same regulatory process of notification or registration, the documentation required for these devices differs from that applicable to others.
Brazil has embraced the notion of regulatory reliance. With RDC 741/2022, ANVISA recognises assessments by Equivalent Foreign Regulatory Authorities (AREEs). Normative Instructions (IN) 289/2024 and (IN) 290/2024 detail the procedures for utilising these assessments. IN 289/2024 applies to medicines, biological products, vaccines and active pharmaceutical ingredients, while IN 290/2024 specifically addresses medical devices.
The applicable AREEs for each sector are as follows.
Medicines, biological products and vaccines:
Active Pharmaceutical Ingredients:
Medical Devices:
Brazil makes use of regulatory decisions of other jurisdictions to optimise its product registration procedures. Therefore, if a company has already obtained authorisations from internationally recognised jurisdictions, the issuance of ANVISA’s authorisations can be expedited. The analysis conducted by AREE can be accepted for the purpose of implementing an optimised analytical procedure facilitated by regulatory trust practices, such as collaborative work and mutual or unilateral recognition. The practice of the optimised analysis procedure will be based on the instructional documentation prepared by the Equivalent Foreign Regulatory Authority, as established in specific normative acts.
For the purposes of adopting the optimised analysis procedure, the instructional documentation of the Equivalent Foreign Regulatory Authority must:
Both pharmaceutical and medical device manufacturing facilities in Brazil need a licence to operate, known as an Autorização de Funcionamento (AFE), issued by ANVISA.
The procedure for obtaining an AFE is outlined in RDC 16/2014 (in force but amended by RDC 860/2024).
Activities authorised by the AFE include manufacturing, storage of raw materials and finished products, and quality control procedures.
The AFE has no expiry date.
Additional notes:
Wholesale distributors of pharmaceuticals and medical devices in Brazil must be licensed by ANVISA. The Authorisation to Operate Pharmacies and Drug Stores (AFE) permits the sale of industrialised medicines, including those under special control per Regulation SVS/MS 344/1998 and updates.
The application process, outlined in RDC 16/2014, Article 28, requires the submission of technical and formal documentation.
Once granted, the AFE for Wholesale allows commercialisation of various products such as medicines, pharmaceutical inputs, health products, cosmetics, personal hygiene items, perfumes and disinfectants between legal entities or to professionals.
The AFE has no expiry date.
As mentioned in 1.3 Different Categories of Pharmaceuticals and Medical Devices, ANVISA categorises pharmaceutical products based on their API and innovative characteristics, as outlined in RDC 753/2022.
Law 6,360/1976 is the primary pharmaceutical law, governing production, marketing, advertising, labelling, inspection, quality control, penalties, importation and marketing authorisation of medicines, drugs, active ingredients and medical devices. Decree 8,077/2013 regulates it.
To secure marketing authorisation for medicinal products, the applicant must be an authorised manufacturer or importer. ANVISA authorisation is mandatory for manufacturing/selling pharmaceuticals and/or importing them before market entry.
Various government agencies enforce import regulations for pharmaceuticals and medical devices.
In Brazil, only a local legal entity can serve as the importer of record for pharmaceuticals and medical devices. Specific requirements must be met.
Eligible importer of record:
Importer of record requirements:
In Brazil, importing pharmaceuticals and medical devices requires prior authorisation from ANVISA.
Key regulations, including RDC 810/2023 amending RDC 751/2022 (in force with amendments), cover risk classification, notification, registration regimes, labelling requirements and usage instructions for medical devices. Additionally, RDC 18/2014 regulates communication to ANVISA regarding temporary or permanent discontinuation or reactivation of medicine manufacture or import.
Import Authorisation (AI) requirement:
Exemptions may apply in certain cases.
Brazil’s non-tariff regulations and restrictions (NTRs) for imports, including pharmaceuticals and medical devices, ensure product safety, quality and compliance.
Basis for imposing NTRs:
Laws and regulations listing products subject to NTRs:
Brazil engages in trade agreements with provisions for trade and regulatory facilitation. Some include the following.
Trade Bloc
Mercosur was formed in 1991 with Argentina, Uruguay, Paraguay and associate members such as Bolivia, Chile, Peru, Suriname and Guyana. Mercosur promotes trade integration via tariff reductions and regulatory harmonisation.
Free Trade Agreements (FTAs)
Brazil has FTAs with various countries:
Trade/Regulatory Facilitation Provisions
FTAs often include the following.
Brazil imposes price controls on pharmaceuticals and medical devices through CMED, regulating prices, fostering competition and setting price ceilings.
Key laws include:
Medical devices undergo economic monitoring per RDC 478/2021, with Normative Instructions 84/2021 and 119/2022 outlining monitoring details.
Drug Price Approval
The process involves submitting economic data and proposed prices based on drug categories outlined in CMED’s Resolution 2/2004.
CMED’s decision is subject to appeals, with final decisions potentially reviewed by federal courts.
Drug Price Categories (Resolution 2/2004)
Appealing Price Decisions
Companies can challenge CMED decisions internally and through federal courts if legal grounds exist.
Drug Price Classification
CMED classifies approved drug prices into three categories.
Price Adjustments and Industry Concerns
Annual price adjustments, criticised for lagging behind inflation, affect drug pricing, though actual market prices often fall below set ceilings, especially for generics.
International reference prices indirectly influence drug pricing in Brazil, particularly in Category I, where they play a significant role. Resolution 2/2004 establishes a price basket comprising nine countries, serving as a benchmark for evaluating manufacturer prices, excluding taxes.
Category I, for new patented drugs offering substantial benefits, is directly influenced by international prices. The proposed PF cannot exceed the lowest PF practised for the same product in the basket of countries, ensuring competitive market entry.
However, drug pricing in Brazil is influenced by factors beyond international prices.
Brazil’s healthcare system blends public and private financing for drugs.
Public System (SUS)
Drug acquisition:
Private System (Health Insurance)
Health insurance coverage:
List of procedures:
Judicialisation:
Brazil employs cost-benefit analysis (CBA) within Health Technology Assessment (HTA) processes for pharmaceuticals and medical devices, though its direct influence on pricing and reimbursement decisions varies.
HTA process and CBA:
Impact on pricing:
Impact on reimbursement:
Limitations of CBA:
Brazil has implemented regulations to oversee physician prescribing and pharmacy dispensing, aiming to ensure rational medication use and control pharmaceutical spending.
The Federal Council of Medicine and ANVISA provide guidance.
Prescription regulations:
Pharmacy regulations:
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