CMC


Mutual recognition of evaluations


The FDA puts a stop to the duplication of evaluations and the double use of resources among agencies in different countries. From November 1 the FDA will recognize the decisions of the Spanish Agency for Medicines and Health Products (Aemps) and 7 other European agencies.

It is the result of the Mutual Recognition Agreement between the US and the EU, the process will be completed in July 2019, spreading through the 28 countries of the EU. The European Commission already recognizes the evaluations of the FDA.

Those resources saved may be allocated to other countries where may be more risk of non-compliance and bad practices.