Drug Registration in Brazil: Decoding ANVISA’s Regulatory

Registering drugs in Brazil means getting approval from ANVISA’s Regulatory (Agência Nacional de Vigilância Sanitária) so that a medicine can be legally sold in Brazil. The process ensures medicines are safe, effective, and high quality. But it can be complex, involves many rules, documents, inspections, and sometimes takes a long time. Understanding how ANVISA works, recent changes, and best practices can help pharmaceutical companies (both local and foreign) navigate the process more smoothly.

Overview of ANVISA’s Regulatory & Legal Framework

• ANVISA is Brazil’s health regulatory agency responsible for drugs, medical devices, cosmetics, etc. 
• Drug regulation is governed by various Resolutions (RDCs), Normative Instructions (INs), and laws, e.g. Law 6,360/1976, plus recent updates like RDC 753/2022 for new, generic, and similar drugs.
• For clinical trials, Resolutions like RDC 945/2024 and RDC 205/2017 define how trials must be submitted, evaluated, and approved.

Types of Drugs & Categories

Some of the categories ANVISA’s Regulatory recognizes:

• New synthetic or semi-synthetic drugs
• Generic drugs and branded generics
• Similar drugs (which are like generics but perhaps with minor differences)
• OTC (Over The Counter) medications
• Biologics and potent drugs with higher risk, which require stricter review

Key Requirements & Steps for Drug Registration

Here are the major steps and what you need at each step.

• Appoint a Local Responsible Partner / Company

Foreign companies must have a legally constituted partner or representative in Brazil, who is responsible for marketing, importation, distribution, and post-market activities.

• Obtain Company Operating Authorization (AFE)

The company must have authorization from ANVISA to operate: manufacture, import, distribute etc. Without this, drug registration cannot proceed.

• Prepare the Dossier (Registration Application)

Use CTD (Common Technical Document) format for many drug types. Includes modules like Quality / Chemistry, Non-clinical, Clinical. Include data: safety, efficacy, manufacturing process, labeling in Portuguese, proof of GMP compliance for both drug product and active pharmaceutical ingredients (API) when required. For APIs, there is something called CADIFA (ANVISA’s API registration requirement) – confirms that the API quality and supplier are acceptable.

• Clinical Trials (if required)

If the drug is novel or has certain risk, ANVISA demands trials. Resolutions define how to apply, how data must be submitted. Sometimes parts of clinical development must be done in Brazil.

• GMP Inspections

Good Manufacturing Practices compliance for manufacturing site(s) is essential. ANVISA may inspect the site or accept GMP certificates from recognized authorities.

• Submission & Review

Submit the registration petition and dossier to ANVISA. It goes through technical review, safety efficacy evaluation. ANVISA may pose queries you must answer.

• Marketing Authorization (MA) Decision

For standard review: ANVISA’s Regulatory has up to 365 days for making a decision. For priority review, timeline is shorter (120 days). Note legal limits can be extended by up to one-third. Once granted, the MA is valid for 10 years from publication. There are special cases (preliminary evidence, “commitment term”) where initial validity is shorter.

• Post-Registration and Renewal

After approval, there are obligations: pharmacovigilance (monitor for adverse events), stability studies, possibly submission of first batches etc. Renewal: after expiry, company must apply for renewal; validity 10 years usually.

Recent Changes & Simplification Efforts

• Resolution No. 954 (starts January 21, 2025): Introduces changes to simplified registration, renewal, post-registration processes. Restricts simplified procedure to companies within same economic group; allows ANVISA to request full dossiers or parts within 60 days.
• Law / resolution updates like RDC 753/2022 covering new, generic & similar drugs.
• Clinical trial rules updated (RDC 945/2024) improving how to get trial approvals etc.

Best Practices & Tips to Smooth the Registration

• Engage with regulatory consultants or local experts familiar with ANVISA’s expectations.
• Prepare high-quality dossier from the start, ensure all required modules, translations, GMP and CADIFA evidence.
• Anticipate inspection timing and ensure manufacturing sites are ready.
• Monitor relevant regulatory updates (new resolutions/instructions) so you are not blindsided.
• Consider whether priority review or simplified pathways are possible.
• Maintain good pharmacovigilance systems early.

Timelines and Validity Summary

Process	Normal Review Timeline	Priority / Fast-Track Timeline	Validity of MA / Renewal
Marketing Authorization (standard)	365 days (+ possible extension of one third)	120 days for priority review	Valid for 10 years in most cases; shorter if under “commitment term” etc.