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CADIFA filing in Brazil
4 Jul 2024

What is CADIFA Filing?

CADIFA (Carta de Adequação de Dossiê de Insumo Farmacêutico Ativo) is a letter issued by ANVISA (Agência Nacional de Vigilância Sanitária) that certifies the approval of a DIFA (Dossiê de Insumo Farmacêutico Ativo), also known as the Active Pharmaceutical Ingredient (API) dossier.

The DIFA includes the Drug Master File (DMF) and other necessary administrative documents, detailing the quality attributes of an API. The approval process ensures that the API meets the regulatory standards set by ANVISA, specifically those outlined in RDC 359.

Obtaining a CADIFA is a prerequisite for registering drug products in Brazil. Both domestic and foreign companies must comply with this requirement.

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Key Points about CADIFA:

API Quality Certification

CADIFA certifies that the API dossier (DIFA) meets the required quality standards set by ANVISA. If the API manufacturer owns a CADIFA, it will begin communicating directly with ANVISA about the API.

Regulatory Standards

The approval process ensures compliance with regulatory standards outlined in RDC 359 and RDC 511/2021.

Flexibility in Standards

Unlike the Certificate of Suitability (CEP) in Europe, CADIFA offers the flexibility of not being tied to a specific pharmacopoeial monograph. ANVISA allows for the use of any recognized pharmacopoeias (e.g., USP, EP, JP) or even in-house specifications as long as they meet the regulatory standards. LATAM drug regulatory affairs course

What CADIFA includes?

Following information is included in CADIFA.

  • Basic API information, such as the CADIFA number, API name, name and address of the DMF holder,
  • Information about manufacturing sites where API and its intermediates are manufactured, storage conditions, packaging description, API specifications, retest or expiry date, and declaration of access.

Starting from August 2023, any domestic or foreign company wishing to register its drug products in Brazil must first obtain a CADIFA (Carta de Adequação de Dossiê de Insumo Farmacêutico Ativo). This requirement is crucial for ensuring that the Active Pharmaceutical Ingredients (APIs) used in drug products meet the stringent quality standards set by ANVISA (Agência Nacional de Vigilância Sanitária).

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