The new regulatory framework for Active Pharmaceutical Ingredients (APIs/IFAs) of the Brazilian Health Regulatory Agency (ANVISA) comes into force. Foreign companies can now register drugs in the Brazilian market by directly submitting petitions for documentary approval at ANVISA’s systems.

The new framework concluded the internalization of guides from the Steering Committee of the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It is comprised of three Resolutions of the Collegiate Board (RDCs) of ANVISA:

RDC n. 359/2020 instituted the Active Pharmaceutical Ingredient Dossier (DIFA, in the Portuguese acronym) and the Active Pharmaceutical Ingredient Dossier Adequacy Letter (CADIFA, in the Portuguese acronym);
RDC n. 361/2020 updated the rules for registration and post-registration of drugs; and
RDC n. 362/2020 established criteria for Good Production Practices certification (CBPF, in the Portuguese acronym) and instituted the inspection program for foreign API producers.

Domestic and foreign companies can now directly submit, to ANVISA’s systems, the documentation that attests the API’s production process and quality, which compose the DIFA, in order to petition for a CADIFA. Companies that possess a CBPF and whose APIs were attested adequate (possess a CADIFA) have those APIs registered.