15 de agosto de 2019

ANVISA NEWS: Public Consultations on the New Regulatory Framework for Active Pharmaceutical Ingredients (APIs)


The Brazilian Health Regulatory Agency (ANVISA), released today on its website, 4 Public Consultations concerning the revision and implementation of the new model for APIs regulation in Brazil. Are they:

Registration and Post-Registration:
  • Public Consultation n. 682 (English version): the establishment of the Active Pharmaceutical Ingredients Dossier ('DIFA') and the Letter of Suitability of Active Pharmaceutical Ingredients Dossier ('CADIFA');
  • Public Consultation n. 683*: amendments of RDC N. 200/2017, and RDC N. 73/2016, to provide for the submission of 'DIFA' in the registration and post-registration of medication, respectively;
Quality and GMP:
  • Public Consultation n. 688*provides for the criteria for certification of Good Manufacturing Practices for international establishments producing active pharmaceutical ingredients.
  • Public Consultation n. 689*: guidelines of qualification of suppliers related to the Technical Regulation of Good Practices of Distribution (and 'Fractionation') of Pharmaceutical Ingredients, approved by the RDC n. 204/2006.

Since 2018, Anvisa's API Registration Department (COIFA) and Drug and Biological Products General Office (GGMED) began a series of meetings with representatives of the regulated sector to discuss and map issues related to the current model of regulation of API in Brazil.

During this process, individual interviews were conducted with each sector segment to understand the specific needs regarding the current regulatory model and the proposals under evaluation (preliminary texts).

A Working Group (Anvisa-Sector), was formally established to officializes the work (Portaria n. 1.754/2018), and 9 face-to-face meetings were held to discuss the base text that gave rise to the Public Consultations released today.

One of the main points of the discussion was the current diversity of requirements required in IFA regulation in Brazil, without standardization and harmonization with the recommendations of the International Council for the Harmonization of Drugs for Human Use (ICH). 

Thus, for the new regulatory framework, a unification of the requirements for all synthetic and semi-synthetic APIs is expected, along with harmonization with international standards.

All texts have a 60-day deadline for contributions through specific formularies available on http://portal.anvisa.gov.br/consultas-publicas.


*The documents are available only in Portuguese.




#be tuned: have you already access the English version of Anvisa’s API Guide website?