Brazil’s ANVISA to Eliminate Backlog of Applications

Regulatory NewsRegulatory News | 04 October 2018 |  By 

Brazilian drug regulator ANVISA said Wednesday at RAPS’ Regulatory Convergence that it would eliminate a backlog of new and generic drug applications by January 2019.

The elimination of the backlog will free the regulator up for new projects, and comes as more than 800 applications were backlogged as of January 2017, Raphael Sanches Pereira, general manager at ANVISA said.


Pereira also said that ANVISA by the end of this year will make a proposal to rely on Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) granted by the European Directorate for the Quality of Medicines and HealthCare (EDQM).

“We want to change API [active pharmaceutical ingredient] registration rules to recognize CEPs to simplify the registration of drugs,” he said, noting the regulator is working with EDQM. Other countries, including Albania, Canada, Algeria and Australia currently accept CEPs.

Meanwhile, for biologics, Brazil is also rolling out a system whereby it would rely, at least partly, on decisions informed by another regulatory agency’s decisions, based on risk-based criteria.

Leaders Call for Closer Collaborations With Industry

Meanwhile, leaders of Cuba’s drug regulatory agency CECMED and Mexico’s Cofepris called for the further tightening of relationships between regulators and industry so that time is not wasted

Rafael Perez Cristina, head of CECMED, said: “If authorities don’t understand the development of new products, they will become an obstacle in the ability to allow quick access to these products.”

Julio Sanchez y Tepoz, head of Cofepris, also said collaborations with industry should be a metric by which
Latin American regulators measure their effectiveness so that patients can gain access to the most innovative products.

“We need to better link the national health systems with regulators and biopharma industry,” Cristina added.

“In a world of constantly evolving technologies, we as regulators need to remove entry barriers and need an international agenda,” Tepoz said.

Click on this link for more news coverage on RAPS' 2018 Convergence from Regulatory Focus.


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