APIs in Brazil: how to register and obtain the GMP certificate

Recommendation

Thursday, 13 February 2025 10.30 - 15.45 h

How to register APIs in Brazil - Live Online Training
Focus on CADIFA and obtaining a Brazilian GMP certificate

In February 2024, the ECA offered the Live Online Training "How to register APIs in Brazil - Focus on CADIFA and obtaining a Brazilian GMP certificate". During the Q&A sessions, many interesting questions were posed to the speakers' team.
With regard to Brazil's Registration procedures for APIs, a set of the most important questions raised during the trainings and the respective answers provided by our speakers Ms Marieke van Dalen, Global Regulatory Specialist, Aspen, The Netherlands, and Ms Susan Swiggers, Customer & Regulatory Support Officer, Aspen, The Netherlands, have already been published here. All answers reflect the opinion of the speakers based on her experiences.

In addition, a list of useful abbreviations and definitions in regard on the Brazilian registration system are collected and provided in the following:

1) CADIFA = Carta de Adequação de Dossiê de Insumo Farmacêutico Ativo = Letter of Suitability of the Active Pharmaceutical Ingredient (similar to the European CEP)

2) CBPF = Certificado de Boas Práticas de Fabricação = Brazilian GMP certificate

3) COIFA = API registration department of ANVISA

4) DIFA = Dossiê de Insumo Farmacêutico Ativo = Brazilian DMF + additional documentation

5) EFRA = Equivalent Foreign Regulatory Authority

6) RCBP = Regulatory Confidence Building Program, includes the following stages:
                    a. Sharing information regarding previous inspections
                    b. Performing joint inspections
                    c. Preparing technical opinion report with conclusion regarding equivalence

7) RDC = Resolução de Diretoria Colegiada = Board of Directors Resolution (Brazilian laws)

8) Solicita System = Digital System of ANVISA for all types of submissions and communication with ANVISA (CADIFA, optimized analysis, changes, deficiency letter and response, etc.)

Additional information and explanations of abbreviations can be found in the "CADIFA Manual". The "CADIFA Manual for Administrative Procedures" of the Brazilian Health Regulatory Agency (Anvisa) describes detailed the requirements which need to be followed for API dossiers and was first published in August 2020. Now it is available in Version 3 (latest updates are made in August 2022) and is published on its website in Portuguese and in English language. Here you can find the "CADIFA Manual for Administrative Procedures, CADIFA Manual nº 01, 3rd Version" on the website of Anvisa.