ANVISA – Questions & Answers on RDC 359/2020, which instituted DIFA and CADIFA for API used in the manufacture of Drug Products

On September 28th, ANVISA published the document Questions & Answers on RDC 359/2020, which instituted the DIFA (Active Pharmaceutical Ingredient Dossier) and CADIFA (Letter of Suitability of the Active Pharmaceutical Ingredient) applicable to active pharmaceutical ingredients (API) used in the manufacture of new, innovator, generic and similar drug products.

The document mentioned brings the main questions related to the New Regulatory Framework of API, published in Brazil on March 2020, which came into force in August 2020. See below some important points of discussion in the new Questions & Answers:

– General clarifications on DIFA, CADIFA and GMP of API issued by ANVISA.

– Information on administrative procedures for CADIFA application at the ANVISA system.

– Clarification of doubts related to the application subject “Expression of Interest”.

– Details about documents to be submitted in Modules 1, 2 and 3 of CTD for CADIFA application.

– Clarifications about post-marketing authorization changes of Active Pharmaceutical Ingredients (API) and DIFA life cycle management.

– Discussion on the transitional period of the legislation (RDC 359/2020) and repeal of RDC 57/2009, and its Normative Instructions (IN 15/2009 and IN 3/2013).

It is also important to mention that the Questions & Answers was published in Portuguese and English version, and can be accessed through the link:

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