ANVISA is in the process of revising the regulation of active pharmaceutical ingredients. The proposal relies on three main concepts:
Adoption of ICH guidelines;
GMP audit conducted by the marketing authorization holder/applicant.
This concept draws from already well-established and successful initiatives, namely the CEP (EDQM) and the Prequalification of APIs (WHO-PQ). The objective is to streamline the regulatory process by establishing a direct line of communication with API manufacturers (both domestic or foreign) and avoiding replication of work. The CADIFA will be ANVISA’s analogue of the CEP or the WHO-CPQ and, once granted, will allow for multiple drug product applications to be submitted without a reassessment of the API.
2. Adoption of all ICH guidelines concerning API quality
As an ICH member, ANVISA intends to harmonize its requirements with those of regulated markets for APIs by formalizing the adoption of the following guidelines.
3. GMP audit conducted by the marketing authorisation holder/applicant.
This concept is based on the premise that the API is a critical component of the drug product formulation and, therefore, compliance with GMP should be verified by the marketing authorisation holder/applicant through an on-site audit of the API manufacturing site.
*ANVISA is also working on a revised policy for inspections of foreign API manufacturer, which is part of a parallel draft Resolution.
Public consultation (CP)
The proposal concerns two Resolutions. The first (CP 682/2019) addresses the Active Pharmaceutical Ingredient Dossier (DIFA) and the Letter of Suitability of the Active Pharmaceutical Ingredient (CADIFA). It is primarily aimed at DIFA holders/API manufacturers. The second (CP 683/2019) Resolution alters two already existing Resolutions: 200/2017 and 73/2016. Its purpose is to adjust the submission procedure for the API documentation by drug product marketing authorisation applicants/holders and institute the GMP audit. On August 14, the public consultation for both Resolutions was published (CP 682/2019 and 683/2019). The period for contributions will be of 60 days starting on August 21. Since the Resolution concerning the DIFA/CADIFA directly and extensively involves foreign manufacturers, its public consultation will also be made available in English through a separate platform during the same period. Questions concerning the public consultation may be sent to email@example.com.
At the end of the form, be sure to click Submit!
For better viewing of the questionnaire, use the browsers Google Chrome or Mozilla Firefox.