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    Pharmaceutical sector in Brazil: regulatory challenges for foreign companies

    By Andrés Berridi, GTLawyers, and Patrícia Fukuma, Fukuma Advogados

    Introduction

    The Brazilian pharmaceutical market continues to expand. According to an IQVIA survey released in March 2026, pharmaceutical retail turnover reached BRL 241.6 billion in 2025, up 11.3% on the previous year1. For foreign laboratories, particularly European ones, the country is a natural destination, whether through the importation of finished products, the setting up of a local manufacturing operation, or the acquisition of a Brazilian laboratory.

    The regulatory challenge, however, tends to be underestimated on one specific point. The foreign company tends to see Anvisa merely as a step to be completed before launch when, in reality, the asset[1] that gives access to the market is the health regularisation of the product (whether through registration or notification), and it belongs to whoever applies for it. And only a company established in Brazil and duly regularised before the health authorities as an importer or manufacturer of medicines may apply for it. Determining who will hold the registration or notification is therefore a structural decision, taken before the first filing, which conditions control over the product throughout its commercial life. This article sets out the main points of attention, from a legal perspective, for foreign companies considering or already conducting pharmaceutical activities in Brazil.

    The regulatory framework and the local presence requirement

    The foundation of the system lies in Law No. 6,360/1976, which subjects medicines and pharmaceutical inputs to the health surveillance regime, and in Law No. 9,782/1999, which created Anvisa. Decree No. 8,077/2013 sets out two cumulative filters: the performance of any activity relating to these products depends on an operating authorisation issued by Anvisa (AFE) and on the licensing of the establishment by the state or municipal health authority (article 2); and no product may be the object of such activities without prior registration (article 7). To this is added the obligation to maintain a legally qualified technical officer (article 5).

    The practical consequence for the foreign group is direct: the parent company, located abroad, may neither hold a registration nor import directly into the Brazilian market. A legal entity in Brazil is required, whether its own or a third party’s, holding an AFE for the intended activity, a local health licence and a pharmacist acting as technical officer. Incorporating that entity and obtaining the AFE are prerequisites for the company to be in a position to file a registration or notification petition with Anvisa, and not parallel steps, which must be reflected in the market entry timeline2.

    There is also an industrial dimension. The manufacturing sites involved in producing the medicines intended for the Brazilian market must hold a Good Manufacturing Practice Certificate (CBPF), in line with the particular features of each product category, issued by Anvisa in the name of the company that will hold the registration in Brazil. In the case of the active pharmaceutical ingredient, the rules on the Active Pharmaceutical Ingredient Dossier and, where applicable, on the CADIFA (RDC No. 948/2024, article 11, items II and III, and its updates) must also be observed. Certification of foreign sites may involve an on-site inspection or the application of reliance, so as to make use of inspections carried out by equivalent authorities, and its timing is often one of the critical factors along the way. Although the registration application and the granting of the CBPF run in parallel before Anvisa, issuance of the CBPF is an indispensable requirement for the registration to be granted.

    Registration of medicines: categories, timelines and reliance

    Medicines may fall within various regulatory categories, such as synthetic (new, innovative, generic, similar), biological, herbal and specific medicines, among others, each governed by its own specific regulation. Advanced therapies and medicines intended for rare diseases are also subject to specific regulation, aimed at prioritising their review.

    As to general timelines, Law No. 13,411/2016 inserted article 17-A into Law No. 6,360/1976 and set maximum periods for Anvisa’s decision: 120 days for registration in a priority category and 365 days in an ordinary category, extendable only once by up to one third of the original period. Requests for clarification suspend the running of these periods until they are answered, which accounts for much of the gap between the statutory period and the actual time until the registration is effectively granted. It is therefore essential that the dossier be prepared rigorously, with a view to minimising such requests and speeding up Anvisa’s final assessment.

    The most significant development of recent years is reliance, a regulatory trust mechanism whereby Anvisa makes full or partial use of assessments, inspections and decisions of Equivalent Foreign Regulatory Authorities (AREEs). In the field of registration and post-registration, RDC No. 741/2022 sets the general criteria for its use, while IN No. 289/2024, and its updates, governs the application of the procedure to medicines, vaccines, biological products and the CADIFA, establishing nine AREEs: WHO, EDQM, EMA, Health Canada, Swissmedic, MHRA, FDA, TGA and PMDA3. For a European laboratory with a product approved by the EMA, for instance, reliance may be an important instrument to materially reduce the review effort and Anvisa’s decision time, provided that the dossier filed in Brazil is consistent with the one assessed abroad and addresses the particular features of the Brazilian context. Differences in formulation, manufacturer or indication may rule out its use. It should be noted, however, that reliance is not necessarily a guarantee that Anvisa’s assessment will be identical to that of the equivalent agencies, since the Agency’s competence and autonomy to take the final decision remain preserved.

    Whoever holds the registration controls the product

    Once the requirements are defined, the central structural decision is the choice of the registration holder, and the three most common alternatives have distinct risk profiles. It should be stressed that only companies holding an AFE to manufacture and/or import may be registration holders in Brazil.

    Under the wholly owned subsidiary model, the foreign group incorporates a Brazilian company, obtains the AFE, generally for the activity of importing medicines, and files the registration in its own name. This is the model offering the greatest control, but with high initial costs, since it requires a dedicated warehouse structure, quality control, pharmacovigilance and a technical officer from the outset; on the other hand, it keeps the regulatory asset within the group.

    Where the option is a local importer or distributor as registration holder, the foreign company may accelerate its entry into the Brazilian market, but creates a dependency: the registration is held in a third party’s name, and that third party will have full access to the registration dossier. In this scenario, choosing the right partner and entering into a sound licensing agreement is the decisive factor for the success of the business. More than that, should the commercial relationship come to an end, the rules governing the transition period must be clear, whether for the transfer of ownership of the registration (Anvisa RDC No. 903/2024) or until a new registration is obtained. In addition, clauses on technology transfer and on the protection of know-how and trademarks, among others, must be validated.

    What Anvisa’s rule on transfer of ownership does not resolve, and only the contract can, is the current holder’s cooperation during the transition period: without its participation in the procedure, the transfer does not take place. For this reason, the agreement with the local holder must provide, at a minimum, for the obligation to transfer ownership upon termination, on any grounds, together with a power of attorney or an equivalent enforcement mechanism; ownership of the technical dossier and of the registration data in favour of the foreign company; the allocation of responsibilities for pharmacovigilance, product recall and communication with Anvisa; a trademark licence limited to the term of the agreement; and rules on the transition of stock after termination4.

    Price and access: CMED and public procurement

    Unlike most sectors, medicine prices in Brazil are regulated. Law No. 10,742/2003 created the Drug Market Regulation Chamber (CMED), which approves the entry price of each product and sets the annual price adjustment. The foreign company must factor this into its business plan before investing, because the price charged in the markets of origin is not automatically replicable.

    The entry price regime was renewed by CMED Resolution No. 3/2025 and its updates, in force since 29 April 2026, which repealed Resolution No. 2/2004 after more than twenty years. The new rule classifies medicines into eight categories, according to their degree of innovation and therapeutic gain, and expands to fourteen the basket of international reference countries, among them France, Germany, Spain, Portugal, Italy, the United Kingdom, the United States and Japan. The criteria for setting the ex-factory price vary according to the category assigned by CMED. Depending on the classification, external price referencing, the cost of treatment against comparators available in the country, therapeutic gain, incremental innovation, prices already existing in the portfolio and specific criteria for biological medicines or medicines resulting from a transfer of ownership may be taken into account. The international pricing strategy must therefore be assessed before the Brazilian launch, particularly where the rule requires comparison with prices charged in the reference countries5.

    The general annual adjustment model takes into account the IPCA (the Brazilian consumer price index) and the productivity and relative price adjustment factors set out in CMED Resolution No. 1/2015, without prejudice to the annual resolution setting the percentages applicable to each market level. Sales to the public sector are further subject to the maximum government sale price and, for certain medicines, to the price adjustment coefficient (CAP), a mandatory discount on the factory price6. Public procurement, governed by Law No. 14,133/2021, accounts for a significant share of the market, and productive development partnerships with public laboratories are a relevant access route for technologies of interest to the SUS (the Brazilian public health system), subject to a technology transfer requirement.

    Additional risks: intellectual property, clinical research, data and compliance

    This article does not seek to exhaust the sector’s regulatory map, but certain additional points deserve attention.

    • As regards intellectual property, Law No. 14,195/2021 repealed article 229-C of Law No. 9,279/1996 and abolished Anvisa’s prior consent for the granting of pharmaceutical patents, which are now subject to examination by the INPI alone. The same law repealed the sole paragraph of article 40, which guaranteed a minimum term of ten years counted from the grant, already declared unconstitutional by the Federal Supreme Court (STF) in ADI 5529. Patent planning must take into account the interaction with the entry of generics and biosimilars.
    • As regards clinical research, Law No. 14,874/2024 established the legal framework for research involving human beings, subsequently regulated by Decree No. 12,651/2025. The ethical review by the research ethics committee (CEP) must be completed within 30 business days of acceptance of the complete documentation, save for the statutory grounds for suspension of the period. For primary clinical trial petitions intended for health registration, the health authority’s review may not exceed 90 business days; once that period has elapsed without a decision, clinical development may begin, provided the relevant ethical approvals have been obtained. This new framework seeks to increase regulatory predictability and Brazil’s competitiveness in attracting multicentre studies.
    • As regards advertising, Anvisa’s RDC No. 96/2008 is currently in force and sets the rules for the advertising of medicines, it being understood that, for prescription products, advertising is restricted to professionals qualified to prescribe or dispense, and that commercial interaction with physicians and pharmacists is subject to health regulation and to sector codes of conduct.
    • As regards data protection, pharmaceutical operations involve the processing of sensitive health data (Law No. 13,709/2018, article 11) in pharmacovigilance, patient support programmes and clinical research, and the transfer of such data to the parent company requires one of the mechanisms set out in ANPD Board Resolution No. 19/2024.
    • As regards compliance, the sector combines the two greatest exposure factors under Law No. 12,846/2013: intense dealings with public officials (public procurement, Anvisa, CMED, health departments) and with healthcare professionals who influence prescription. The integrity programme of the Brazilian operation must be designed for this reality, and not adapted from a generic model.

    Practical recommendations at the pre-investment stage

    The experience of foreign laboratories already established in Brazil points to certain precautions that precede the decision to invest.

    The first is to map the full regulatory path before choosing the structure: product category, eligibility for reliance, certification of the foreign site, price category at CMED and a realistic timeline to the first sale. This map determines the working capital required and, frequently, the very viability of the import model.

    The second is to decide, deliberately, who will hold the registration and to reflect that decision in the contract from day one. Choosing a local partner may be the most efficient route, provided the contract treats ownership of the registration as an asset of the foreign company, and not as an accessory to the commercial relationship.

    The third is to obtain regulatory, legal and tax advice specialised in the sector before entering into binding commitments with partners, distributors or sellers of local laboratories7.

    Conclusion

    The Brazilian pharmaceutical sector is regulated in all its dimensions: who may operate, what may be sold, at what price and to whom. For the foreign company, this does not mean inaccessibility, but rather the imperative of a sound market access plan covering every stage of the process. The recent evolution of the regulatory framework, with reliance, the new clinical research law and CMED’s new pricing regime, has brought Brazil closer to international practice and is making the measures to be adopted more predictable. What remains, and only legal planning resolves, is the logic that the registration belongs to whoever applies for it in Brazil. Companies that treat this question as a structural decision, and not as a regulatory formality, reach the market with control over their product and with less friction when partners exit, when the business is sold or when the portfolio is expanded.

    Notes

    References

    • Anvisa, RDC No. 948, of 12 December 2024 (registration of medicines).
    • Anvisa, RDC No. 741, of 2022, consolidated version, and Normative Instructions No. 289/2024 and No. 338/2024 (reliance).
    • Anvisa, RDC No. 903, of 6 September 2024 (transfer of ownership of registration).
    • CM-CMED Resolution No. 3, of 29 December 2025, consolidated version (pricing of new medicines).
    • Law No. 14,133, of 1 April 2021 (public procurement and administrative contracts).
    • Law No. 9,279, of 14 May 1996, and Law No. 14,195, of 26 August 2021 (industrial property).
    • Law No. 14,874, of 28 May 2024 (clinical research involving human beings).
    • Law No. 13,709, of 14 August 2018 (LGPD), and ANPD Board Resolution No. 19/2024.
    • Law No. 12,846, of 1 August 2013 (Anti-Corruption Law).
    • RDC No. 96/2008, of 17 December 2008 (advertising).
    1. IQVIA, survey commissioned by Abrafarma, released in March 2026. Available at: https://sincofarmasp.com.br/2026/03/04/faturamento-do-varejo-farmaceutico-avanca-113-em-2025/. ↩
    • RDC No. 741/2022, together with Normative Instruction No. 289/2024, subsequently amended by, among others, Normative Instructions No. 403/2025 and No. 442/2026, governs the use of assessments of Equivalent Foreign Regulatory Authorities in registration and post-registration procedures for medicines, biological products and vaccines, as well as in the issuance of the CADIFA. Normative Instruction No. 338/2024 governs the optimised procedure for clinical trials, together with RDC No. 945/2024. The list of authorities and the scope of products covered by each must be checked against the version in force at the time of filing. ↩
    • The same logic applies to M&A transactions involving Brazilian laboratories: regulatory due diligence must confirm the ownership and validity of the registrations, the status of the AFE and of the CBPF, and the existence of pending matters before Anvisa and CMED, because the value of the asset acquired is, to a large extent, the value of its registration portfolio. ↩
    • CMED Resolution No. 3/2025 and its updates, published on 24 December 2025 and republished on 30 December 2025, with a 120-day transition period. ↩
    • The CAP is governed by CMED Resolution No. 3/2011. ↩
    • The tax aspects of pharmaceutical operations (taxation on importation, special regimes and the effects of the consumption tax reform) are not addressed in this article and require specific analysis. ↩

    [1]It should be clarified that, for Anvisa, the registration is not understood as an asset in the strict sense, but rather as a concession granted by the State to the administered party, which may be reviewed at any time on the basis of the health legislation in force.