What Is a CADIFA?

The Carta de Adequabilidade do Dossiê de Insumo Farmacêutico Ativo (CADIFA) is a regulatory document or letter by the Agência Nacional de Vigilância Sanitária (ANVISA), the regulatory agency of Brazil. It shows that a DIFA, or Drug Master File (DMF) and other documents related to the Active Pharmaceutical Ingredient (API) has been evaluated and approved by ANIVSA.

CADIFA: Ensuing Safety, Efficacy, and Quality in Brazil

CADIFA plays a significant part in registering medicine in Brazil, especially for APIs by certifying compliance and streamlining the registration process. The letter confirms that the API dossier or DMF meets ANVISA's established standards. This letter includes key API details, like CADIFA number, API name, DMF holder's info, manufacturing site addresses, API specifications, storage, packaging, retest/expiry date, and access declaration.

Quality, safety, and efficacy pharmaceutical products are assured by CADIFA's guarantee that API manufacturing procedures adhere to GMP guidelines. Brazil requires this as a prerequisite for product registration.

There is no longer a need to reevaluate the API dossier or DMF for every drug product registration application as the authorised CADIFA covers all subsequent submissions for the same API.

Challenges in obtaining CADIFA certificate.

Obtaining CADIFA approval for pharmaceutical ingredients can be quite challenging for pharmaceutical companies as the new CADIFA regulations are complex to navigate through. It's not easy for companies to understand all of the new resolutions from the RDC board that have completely changed Brazil's API regulations.

Obtaining an approval from ANVISA takes quite a while; approximately 15–18 months for standard medications and two years for combination medications. Companies need to act quickly to finish all CADIFA-related tasks within that deadline.

Manufacturers must make sure that their procedures comply with quality control standards, and they might need help getting ready for the inspection.

The regulatory process is complex and requires effective communication. It can be challenging for businesses that are new to Brazil to communicate with ANVISA.

DDReg’s Capabilities

DDReg has vast experience with ANVISA in the Brazilian market for successful product registration. The changes associated with CADIFA can create several challenges for companies that wish to penetrate the Brazilian market. DDReg can provide the support in obtaining a CADIFA within the timelines, submitting via the Solicita system, and DMF review to ensure successful CADIFA.

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