News on the various Mutual Recognition Agreements (MRAs)

News on the various Mutual Recognition Agreements (MRAs)

Europe On 19 April, the “Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2021” was published. This annual report of the GMP/GDP Inspectors Working Group (GMP/GDP IWG) gives a short but good overview of what was...
GMP and GDP certificates no longer on paper

GMP and GDP certificates no longer on paper

Belgium Certificates for Good Manufacturing Practice or Good Distribution Practice can be queried in the EudraGMDP database. The FAMHP will no longer automatically provide paper versions of these certificates, only upon request via this request procedure. Source:...
Recognition of the FAMHP by FDA

Recognition of the FAMHP by FDA

Europe The FDA has recognized all 28 EU member states. This means that starting 11 July 2019, the US and the EU have fully implemented the mutual recognition agreement (MRA).  Every year, EU national authorities and the FDA inspect many production sites of...

New EU GMP directive

Belgium The European Union (EU) has published its new directive for manufacturers of pharmaceutical products. This directive replaces the existing directive (Directive 2003/94/EC) on medicinal products for human use. The new EU Good Manufacturing Practice (GMP)...