Brasília – A director of Brazil’s National Health Surveillance Agency (Anvisa) has proposed creating a pilot program to speed up the regulatory review of synthetic medicines, aiming to reduce the backlog of pending applications. In an interview, director Daniela Marreco Cerqueira said the initiative would reinforce policies launched in 2025 to improve efficiency in the agency’s drug evaluation process.

The proposed pilot would test new procedures to streamline technical analysis and shorten review timelines for certain categories of synthetic drugs. According to Cerqueira, the initiative seeks to maintain regulatory rigor while improving predictability for pharmaceutical companies and addressing delays that affect market entry of new medicines in Brazil.

The discussion occurs amid broader efforts within Anvisa to modernize regulatory processes and strengthen the agency’s capacity to evaluate increasingly complex pharmaceutical technologies.

Source: JOTA