On April 1st, 2020, Brazil’s ANVISA published new landmark regulations referring to active pharmaceutical ingredients (APIs). This new set of rules consists of three separate guidelines for local pharmaceutical segment stakeholders, known as “RDCs”. These are RDC 359/2020, RDC 361/2020 and RDC 362/2020, and they represent a complete overhaul of the API regulatory landscape in Brazil. The aim is to ensure that all Drug Master Files (DMFs) for future applications are reviewed under these provisions.
ANVISA has made a clear move towards regulatory convergence over the past few years. In 2016, it became a member of the International Council for Harmonization, and, a few months later, signed a memorandum of understanding with the European Directorate for the Quality of Medicines in 2017. When examining the new regulatory framework, we can clearly notice the influence of exchanges between ANVISA and these organizations.
The paradigm shift embedded in the landmark new regulatory framework will bring about a much-anticipated direct interaction between the authority and the DMF holder/API manufacturer. In addition, it will streamline the process for subsequent petitions using any given prior-reviewed DMF — or as, ANVISA calls it — DIFA (Dossiê do Insumo Farmacêutico Ativo). At the end of a successful review, the DIFA holder will receive a certificate of suitability from ANVISA. This certificate is called a CADIFA (Carta de Adequabilidade do Dossiê de Insumo Farmacêutico Ativo) which is equivalent to the Certificate of Suitability (CEP) in Europe.
For this new chapter in Brazilian regulations, Teva api brings to the table:
- An extensive knowledge of similar centralized procedures for DMF review in main markets (such as EDQM in Europe and GDUFA in US).
- A strategically designed structure for global regulatory affairs, which includes a specialized unit for electronic submission of documentation.
- An expert in Brazilian regulatory affairs who will recruit Portuguese-speaking personnel located in São Paulo, Brazil.
Our goal is to set the stage for our customers to operate efficiently and successfully under these new regulations, making for the blueprint of a sustainable and lasting partnership in Brazil.
