Retail Pharmacy in Brazil Regulatory Changes Analysis¶
Potential Regulatory Changes¶
The Brazilian retail pharmacy value chain is subject to ongoing evolution in its regulatory landscape, primarily driven by the National Health Surveillance Agency (ANVISA) and the Chamber for the Regulation of the Drug Market (CMED), alongside broader governmental reforms. Several potential regulatory changes and recent updates are poised to significantly impact the industry:
ANVISA continues to refine its regulations to enhance sanitary control and align with international standards. A key area of focus has been Active Pharmaceutical Ingredients (APIs). New regulations (RDC 359/2020, 361/2020, and 362/2020), effective from August 2023, overhauled the API regulatory landscape, creating a clearer, distinct process and requiring companies to obtain a CADIFA (Letter of Suitability) from ANVISA for their APIs to register drug products in Brazil. This aims to streamline the process and improve interaction between ANVISA and API suppliers. Additionally, ANVISA has updated regulations on good pharmacovigilance practices for marketing authorization holders (RDC No. 967/25, effective March 20, 2025), modifying requirements for monitoring adverse effects.
Monitoring and control of generic drugs are also being strengthened by ANVISA. New regulatory measures, effective January 2025 with a six-month adaptation period, intensify the monitoring of generic drugs to ensure their safety and efficacy. These measures include stricter requirements for submitting Periodic Safety Reports (PSRs) and more comprehensive bioequivalence tests covering a wider range of patient profiles. ANVISA also updated the List of Reference Medicines (LMR) on March 20, 2025, which is crucial for defining the basis for generic and similar medications.
In a move towards digital transformation and increased efficiency, ANVISA implemented RDC 947, effective March 13, 2025, making the use of the Electronic Protocol compulsory for all document submissions. This eliminates paper submissions, aiming to accelerate analysis and decision times, reduce costs, and improve traceability. Furthermore, ANVISA is considering updates to rules applicable to pharmacy and drugstore services to potentially allow the online purchase and sale of drugs subject to special control, aligning with the broader trend of digital health adoption and remote medicine delivery. ANVISA's Innovation Policy, established by Ordinance 1,100/2023, also signals the agency's intent to promote innovation and adopt digital transformation in its processes.
CMED, responsible for drug price regulation, continues to issue annual adjustments to maximum medicine prices. CMED Resolution No. 01/25, published on March 31, 2025, established new maximum price adjustment rates for medicines sold in pharmacies, with varying percentages for different levels. CMED is also actively reviewing its pricing framework. A public consultation was initiated on May 5, 2025, to gather feedback on revising the criteria for pricing new products and new presentations of drugs, including specific considerations for incremental innovation and biosimilars. There is also discussion and consideration regarding potentially lowering the price ceiling for medicines, although officials suggest any change would be modest to maintain the retail discount system.
Beyond the specific pharmaceutical regulations, the broader Brazilian tax reform, introduced in late January 2025 with a 10-year transition period, will replace several existing taxes with two new VAT-like taxes (CBS and IBS). This reform aims to simplify the complex tax system, reduce compliance costs, and align Brazil's system with international practices.
Additionally, regulatory developments are supporting the expansion of pharmaceutical services in retail pharmacies. Resolution No. 05/25 from the Brazilian Federal Pharmacy Council (CFF), published on March 17, 2025, allows pharmacists to establish pharmacotherapeutic follow-up profiles for patients and prescribe certain medicines based on these profiles, further solidifying the pharmacist's role in patient care. The liberalization of regulations post-COVID-19 has also facilitated pharmacies transforming into "Health Hubs" offering various services, which was partly driven by the need to reduce congestion in emergency rooms.
| Potential Regulatory Change | Potential Impact on Value Chain Stage(s) |
|---|---|
| ANVISA API Regulations (CADIFA) | Manufacturing: Increased complexity and cost for API manufacturers and drug product manufacturers sourcing APIs, need for direct interaction with ANVISA. Potential delays in product registration if API documentation is not compliant. |
| ANVISA Generic Drug Monitoring (PSRs, Bioequivalence) | Manufacturing: Increased costs and operational burden for generic drug manufacturers due to enhanced monitoring and testing requirements. Potential impact on smaller manufacturers. |
| ANVISA Good Pharmacovigilance Practices Update | Manufacturing: Need to update internal pharmacovigilance systems and reporting procedures to comply with new requirements. |
| ANVISA Electronic Protocol Mandate | Manufacturing, Distribution, Retail: Streamlined submission processes, potentially faster approval/analysis times, reduced administrative costs related to paper handling. Requires investment in digital systems and training. |
| Potential ANVISA Regulation on Online Sale of Special Control Drugs | Retail: Significant opportunity for e-commerce expansion but requires robust systems for prescription control, security, and logistics compliant with strict regulations. Potential increase in competition. |
| ANVISA Update of Reference Medicines List | Manufacturing: May affect ongoing development projects for generic and similar drugs, requiring adjustments to technical requirements and regulatory submissions. |
| CMED Adjustment of Maximum Price Rates | Manufacturing, Distribution, Retail: Directly impacts revenue potential and margins. Recent adjustments provide some price increases, influencing profitability across the chain. |
| CMED Revision of Pricing Criteria for New Products/Presentations | Manufacturing: Changes how prices are set for new drugs and formulations, potentially influencing product launch strategies, investment in innovation (especially incremental), and market access. |
| Potential CMED Lowering of Price Ceiling | Manufacturing, Distribution, Retail: Potential pressure on margins, particularly for lower-cost medicines and smaller retailers. Could impact the viability of certain products in the market. |
| Brazilian Tax Reform (CBS/IBS Implementation) | All Stages: Simplification of the tax system over the long term, potentially reducing compliance costs. Requires significant initial adjustments to accounting, pricing strategies, and cash flow management during the transition period. May shift tax burden between sectors. |
| CFF Resolution on Pharmacist Pharmacotherapeutic Follow-up and Prescription | Retail: Enhanced role for pharmacists, enabling expansion of pharmaceutical services and patient care offerings. Potential for new revenue streams and increased value proposition for pharmacies. |
| Continued Liberalization of Regulations for Pharmacy Services ("Health Hubs") | Retail: Supports the expansion of services like vaccinations, tests, and chronic condition monitoring. Requires investment in infrastructure, training, and navigating evolving service-specific regulations. |
References¶
Abradilan. Crescimento das grandes redes de farmácias. https://abradilan.com.br/crescimento-das-grandes-redes-de-farmacias/ Abradilan. Dez maiores farmacêuticas do Brasil detêm 48,6% das vendas. https://abradilan.com.br/dez-maiores-farmaceuticas-do-brasil-detem-486-das-vendas/ E-Commerce Brasil. Varejo farmacêutico brasileiro soma R$ 158,4 bi em 2024. https://web.archive.org/web/20240523095902/https://ecommercebrasil.com.br/noticias/varejo-farmaceutico-brasileiro-soma-r-158-4-bi-em-2024 Estadão RI. Principais redes de farmácias faturaram R$ 91,3 bi em 2023. https://web.archive.org/web/20240509012914/https://conteudo.estadao.com.br/system/public/estadaori/2024/04/29/principais-redes-de-farmacias-faturaram-r913-bi-em-2023.html Giro News. Redes de farmácias faturaram R$ 91,3 bilhões em 2023; RD segue no topo do ranking. https://web.archive.org/web/20240520122416/https://gironews.com/farma-cosmeticos/redes-de-farmacias-faturaram-r913-bilhoes-em-2023-rd-segue-no-topo-do-ranking/ InovaFarma. Confira os números atualizados do mercado de varejo farmacêutico no Brasil. https://web.archive.org/web/20240523095025/https://onovovarejo.com.br/inovafarma-numeros-atualizados-mercado-varejo-farmaceutico-brasil/ Investe SP. Brasil soma 47% do mercado farmacêutico na América Latina. https://web.archive.org/web/20240517191733/https://www.investe.sp.gov.br/noticia/brasil-soma-47-do-mercado-farmaceutico-na-america-latina Novo Varejo. Conheça as 5 maiores redes de farmácia do Brasil. https://web.archive.org/web/20240523100517/https://onovovarejo.com.br/5-maiores-redes-de-farmacia-brasil/ Panorama Farmacêutico. Ranking das grandes redes de farmácias da Abrafarma. https://web.archive.org/web/20240523094400/https://panoramafarmaceutico.com.br/ranking-grandes-redes-farmacias-abrafarma-2024/ Panorama Farmacêutico. Redes de farmácias mantêm projetos de expansão para 2024. https://web.archive.org/web/20240523095253/https://panoramafarmaceutico.com.br/redes-de-farmacias-mantem-projetos-de-expansao-para-2024/ Panorama Farmacêutico. Ranking das redes de farmácias mostra consolidação do setor. https://web.archive.org/web/20240523095536/https://panoramafarmaceutico.com.br/ranking-redes-de-farmacias-mostra-consolidação-do-setor/ Pague Menos tem receita bruta de R$3,1 bi no 1T24. https://web.archive.org/web/20240523100844/https://agenciabrasil.ebc.com.br/economia/noticia/2024-05/pague-menos-tem-receita-bruta-de-r31-bi-no-1t24