BRAZIL Law and Practice Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation Brazil regulates medicines and medical devices through a layered federal regime anchored in statute and fleshed out by ANVISA’s technical rules. The core legal framework consists of four primary laws: • Law 6,360/1976 (sanitary control and marketing authorisation); • Decree 8,077/2013 (implementation); • Law 6,437/1977 (infractions and penalties); and • Law 9,782/1999 (establishing the National Health Surveillance System and ANVISA’s mandate). Medical Devices Device regulation builds on Law 6,360/1976 through numerous National Health Surveillance Agency ( Agên- cia Nacional de Vigilância Sanitária – ANVISA) formal regulatory resolutions ( Resoluções da Diretoria Cole- giada – RDCs), including RDC No 751/2022 (risk clas- sification and regularisation) and RDC No 665/2022 (GMP). The regulatory scope covers dossier content, labelling/instructions for use (IFU) standards, clinical investigations, in vitro diagnostics (IVD) performance evaluation, post-market vigilance, field safety actions, software as a medical device, sterilisation, import licensing, advertising, unique device identification, and special pathways for notifications and compas- sionate use. Normative Instructions and guidance documents supplement these RDCs. Medicines Medicines are governed by a similar RDC matrix, with ANVISA RDC No 658/2022 establishing general GMP requirements. Additional rules address registration pathways (new drugs, generics, biologics, biosimilars, radiopharmaceuticals, advanced therapies), stability, bioavailability/bioequivalence (BA/BE), dissolution, labelling, pharmacovigilance, controlled substanc- es, clinical research, importation, serialisation and advertising. Obligations are category- and life cycle- dependent. Pricing and Reimbursement Price controls fall under Law No 10,742/2003, admin- istered by the Pharmaceutical Market Regulation Chamber ( Câmara de Regulação do Mercado de Med-
icamentos – CMED) with ANVISA as executive secre- tariat. Public reimbursement decisions are informed by the National Committee for the Incorporation of Technologies in the SUS ( Comissão Nacional de Incor- poração de Tecnologias no SUS – CONITEC) (created by Law No 12,401/2011), which conducts health tech- nology assessments (HTAs) for SUS incorporation. Institutional Roles ANVISA serves as the central federal sanitary author- ity, handling registration, company authorisations, good manufacturing practice (GMP) certification, border controls and post-market surveillance. State and municipal bodies manage local licensing, inspec- tions and first-instance proceedings under Law No 6,437/1977. CMED sets medicine price caps, while CONITEC advises the Ministry of Health on public coverage. Legal Structure ANVISA is a special-regime autarchy with enhanced autonomy, fixed-term directors and partial fee-based funding, linked to but independent from the Ministry of Health. State and municipal authorities co-ordinate through the SNVS without hierarchical reporting to ANVISA. CMED is an interministerial collegiate without separate legal personality, and CONITEC is a perma- nent advisory body within the Ministry of Health. 1.2 Challenging Decisions of Regulatory Bodies From a regulatory perspective, challenging decisions in the pharmaceutical and medical device space pri- marily involves contesting individual administrative acts issued by ANVISA and other health surveillance authorities within the National Health Surveillance System ( Sistema Nacional de Vigilância Sanitária – SNVS) at the state and municipal level. These chal- lenges typically relate to case-specific decisions directly affecting a company or product, such as refusals or restrictions in registration/regularisation procedures, technical requirements issued during regulatory review, post-market measures (including suspensions of commercialisation, recalls or field actions), GMP-related outcomes (eg, inspection find- ings or certification impacts) and enforcement actions or penalties (including infraction notices and fines).
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