Drug Registration Archives

Anvisa’s New Regulation for Biosimilar Drugs Registration

Posted onJune 2, 2024June 2, 2024

The Brazilian Health Regulatory Agency (Anvisa) has approved a new regulation for the registration of biosimilar drugs. This move aims to streamline the approval process, ensuring that biosimilars meet the required safety, efficacy, and quality standards while promoting innovation and Read More …

Anvisa Approval of Foreign Regulatory Assessments

Posted onMarch 20, 2024March 20, 2024

During its public Collegiate Board meeting on March 19, 2024, Anvisa approved an instructional norm aimed at establishing criteria for the use of assessments from foreign equivalent regulatory authorities within its framework. This recent Anvisa approval represents a significant milestone Read More …