Brazil - Establishes the technical requirements for the execution of clinical trials with advanced therapy medicinal products

Brazilian Health Regulatory Agency (ANVISA) establishes the technical requirements for the execution of clinical trials with advanced therapy medicinal products in Brazil and provides other measures. 

Products: advanced therapy medicinal products

Proposed date of adoption: 23 December 2020

Proposed date of entry into force: 23 December 2020

Final date for comments: Not applied.

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.