Brasília – The Health Committee of the Chamber of Deputies passes a bill that restructures Brazil’s drug-registration rules by removing the current requirement for manufacturers to hold Good Manufacturing Practice (GMP) certification issued in their country of origin. Under the proposal, pharmaceutical companies would no longer need proof that their facilities are certified abroad to obtain market authorization in Brazil.

The measure amends existing legislation to simplify regulatory pathways, allowing Anvisa to evaluate GMP compliance directly through its own inspections or recognized international assessments. Lawmakers argue that the change eliminates bottlenecks created when foreign authorities do not provide timely certification, while maintaining safety and quality standards through Anvisa’s oversight.

Supporters say the update could accelerate registration timelines, expand competition, and promote greater autonomy for the national regulatory framework. The bill will now proceed to further deliberation in the Chamber.

Source: Agência Câmara de Notícias