Brazil’s resolution seeks to fast-track product's approval.
On August 17, 2022, the country’s national health authority, ANVISA, passed a resolution referred to as an optimized analysis procedure, that would help to accelerate approval of products that have been approved by equivalent foreign regulatory authorities.
Products affected by the resolution include medicines for human use with synthetic and semi-synthetic active principles, classified as new, innovative, generic and similar.
The resolution, which entered into force on September 1, specifically allows for analysis carried out by named health authorities to be admissible as part of ANVISA’s surveillance process.
As a member of the ICH Steering Committee, ANVISA is working toward harmonizing the interpretation and application of guidelines and requirements for product registration as well as pharmacovigilance and clinical research activities.
Recognizing analysis conducted by equivalent regulatory authorities and creating optimized analysis procedure registration routes serves that goal.
The instructional documentation may be used in whole or in part as a complementary reference to ANVISA’s technical analysis.
The framework allows for the possible replacement of new studies with existing data from clinical studies carried out in other countries.
The resolution provides for the input of technical data in the decision-making process, for example, for protocols, guides, monographs, authorizations, votes, letters, certificates, declarations, and reports or technical opinions issued by entities, national or international information regarding the safety and efficacy of the drug or API.
This also includes real-world evidence and real-life data, a growing priority for regulators.