Drug Registration in Brazil: Decoding ANVISA’s Regulatory Pathways for Faster Market Entry

The pharmaceutical industry in Brazil is among the most vibrant and expanding in Latin America. At the centre of Brazil’s regulatory landscape lies ANVISA (National Health Surveillance Agency), the country’s autonomous drug authority ensuring that all medications entering the Brazilian market meet the strict requirements of quality, safety and efficacy.

Established in 1999 ANVISA oversees not only pharmaceuticals but also food, cosmetics medicine and other health related products. As a result of the growing global alignment, ANVISA has improved convergence by fortifying its relationships with ICH PIC/S and other regulatory networks. Let’s examine how quick market access is shaped by ANVISA’s pathways.

Key Steps in Pharmaceutical Product Registration in Brazil

Compliance with ANVISA standards helps ensure that your product meets Brazilian health and safety regulations, supporting market entry and building consumer trust.

Authorization Requirements: Pharmaceutical companies operating in Brazil must obtain an authorized license, Autorização Especial de Empresa (AE) from ANVISA if handling-controlled substances such as narcotics or psychotropics. Activities for such products including handling, production and processing of materials is governed by RDC No. 16/2014.
Petition and Protocol Registration: Drafting a thorough petition and registering a protocol with ANVISA is the key to registration process. To speed up ANVISA’s review process, correctly classify the product using the appropriate Código de Assunto (subject code).
Product Classification: It’s critical to classify your product correctly. Agrotóxicos, health products and medical devices are some of the products that need special registration procedures.
Medical Devices Registration (RDC 185/2001): Devices such as syringes, needles, and other health products follow a separate registration pathway with ANVISA. These are governed by RDC 185/2001 and require risk-based classification and compliance checks distinct from pharmaceuticals.
Continuous Compliance and Renewals: In Brazil, product registrations are valid for ten years after which they must be renewed. To prevent interruptions, this procedure should start six to twelve months prior to expiration.

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Classification of Drugs under ANVISA

ANVISA oversees several drug classes each with unique regulatory pathways based on relevant RDCs.

Drug Type	RDC / Normative Instruction	Notes
Novel synthetic & semi-synthetic medications	RDC 753/2022	Standard approval pathway
Generic & Branded Generics	RDC 753/2022	Updated framework
Homeopathic & Anthroposophic products	RDC 721/2022	Special classification
Specific medications	RDC 24/2011 & RDC 242/2018	Low/medium risk drugs
Notified medications (low risk)	Norm IN 106/2021 & RDC 576/2021	Simplified notification
OTC medications	RDC 242/2018, Norm IN 285/2024, RDC 888/2024	Over-the-counter products
Medicinal herbs	RDC 26/2014, Norm IN 301/2024	Traditional/herbal products
Medicinal gases	RDC 870/2024	Specific handling required
Biologics	RDC 55/2010	Full dossier required
Pharmaceuticals for radiotherapy	RDC 738/2022	Specialized pathway

CTD modules that comply with ICH guidelines

Dossier submissions must adhere to the Common Technical Document (CTD) format, which is in line with ICH guidelines

Module 3: Manufacturing and quality (CMC data)
Module 4: Nonclinical (pharmacology/toxicology).
Module 5: Clinical (Trials, BE, Comparability)
Submissions must include the Certificate of Pharmaceutical Product (CPP) GMP certificate, Portuguese labelling and be filed electronically through the Data visa system.

International applicants are required to designate a legally registered partner in Brazil to serve as the accountable party for importation distribution marketing authorization and post-market surveillance.

What are the Different Regulatory Pathways for Faster Market Entry in Brazil?

To speed up drug registration and market access ANVISA provides several mechanisms as mentioned below:

Standard Market Authorization

Timeline: 365 days (standard), 120 days (priority review).
Notes: Official decision-making may extend these periods by up to one-third.

Priority (Fast-Track) Review – RDC 205/2017

Within 60 days of submission to another authority (e.g., FDA, EMA), the manufacturer meets ANVISA.
After a formal request within 30 days, ANVISA has 60 days to either decide or request additional information.

Reliance and Expedited Pathway – RDC 913/2024, IN 289/2024

ANVISA accepts conditional approvals or quality changes based on approvals from strict authorities (FDA, EMA, Health Canada, PMDA).
Streamlines tech-transfer submissions and authorization for biologics.

Simplified Pathways for Biosimilars and Biologics – RDC 875/2024

If robust comparability data is available, certain clinical and non-clinical studies may be bypassed.

Recent Regulatory Updates for Drug Registration in Brazil

The Recent Changes that are to be followed for faster market approval are stated below:

New and Innovative Medicines (2022): ANVISA unveiled an updated framework in October 2022 that provides both comprehensive and shortened registration pathways. When possible, it permits replacing new clinical trials with data from existing ones promoting innovation without sacrificing safety.
Resolution 954: Comes into effect on January 21, 2025, which streamlines the registration process and limits submissions to companies within the same economic group, ensuring consistency in quality and pricing compliance.
API GMP certification or CADIFA: Available to foreign API manufacturers. It verifies GMP compliance and is transferred to other product registrations. Approval periods usually last for 15–18 months or up to 24 months for fixed-dose combinations.
Completely paperless filing: From March 13, 2025, ANVISA only accepts digital dossiers via Datavisa/eCTD, fully phasing out paper submissions.

Challenges associated with Drug Registration in Brazil

Longer market entry timelines are caused by the burden of comprehensive data submissions for clinical trials and manufacturing procedures as well as possible language barriers and regulatory changes.

Limitations

Impact on Market Entry

Certificate of Pharmaceutical Product requirement

Delayed submissions and extends approval timelines

Slow review initiation & long deadlines

Delays in both starting and completing regulatory review

Strained clinical trial timelines

Risk of legal breaches and stalled research

Complex biosimilar pathways

Safety concerns due to non-comparative approvals; delays in market entry

Translation, GMP, import/tax burdens

Higher administrative cost and planning hurdles

Post-approval payment/access delays

Real-world availability delayed, prompting judicial recourse

Weak pharmacovigilance systems

Reduced transparency and slower safety response

Strategies for Faster Market Entry in Brazil

Compliance with ANVISA standards ensures that the drug to be launched meets all health and safety regulations, supporting market entry and building consumer trust.

Strategic Product Categorization: When there is a public health emergency pursue priority review. Investigate the shortened pathway for novel medications in accordance with 2022 guidelines.
Leverage CADIFA for APIs: Obtain GMP certification early to accelerate multiple filings.
Master Datavisa and eCTD Submissions: To reduce back and forth make sure the dossier is complete up front.
Audits: Prepare for audits under Resolution 954 and ensure readiness to respond to information requests.
Engage Local Expertise: Select experienced Brazilian partners to help you navigate the complexities of language law and procedure.

Conclusion

From traditional to accelerated or abbreviated routes, ANVISA’s changing regulatory architecture provides a variety of pathways suited to drug complexity and urgency. To ensure compliance and ensures faster approvals and reduces time-to-market barriers. It is important to strategically align your regulatory strategy with operational readiness and dossier.

Thus, in the rapidly evolving Brazilian healthcare market pharmaceutical companies can greatly minimize their time to market with the appropriate dossier digital readiness and pathway selection.

How can DDReg help?

At DDReg, we specialize in end-to-end pharmaceutical regulatory solutions tailored for the Brazilian pharma market. Our team experts and regulatory professionals ensure global and local best practices tailored to ANVISA expectations. 

With our deep expertise across Brazil and over 16 years of regulatory leadership, DDReg empowers manufacturers to enter the Brazilian market confidently, compliantly, and efficiently. 