Medicine shortages: improved reporting and communication?

Medicine shortages: improved reporting and communication?

Europe The European Union taskforce  has published two documents: 1) guidance for marketing authorisation holders on reporting of shortages in the EU. The document provides guidance to the pharmaceutical industry to facilitate the detection and early notification to...
Drug-device combinations

Drug-device combinations

Europe The European Medicines Agency has published a Draft guideline on the quality requirements for drug-device combinations. This guideline will provide guidance on the documentation expected for Drug-Device Combinations (DDCs) in the quality part of the dossier for...
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...

EMA’s Annual Report on the EudraVigilance Database

Europe On 27 March 2019, the Annual Report 2018 on the European database for the collection of adverse reactions to medicinal products, Eudravigilance, was published by the EMA. It’s a summary of the current status of the database. EudraVigilance is used to...