Saudi Arabia has explained what information on a drug’s review will be made public following a marketing authorization decision. 

Revised labeling requirements for unauthorized investigational and auxiliary medicinal products under the EU Clinical Trial Regulation have been published in the Official Journal.

The European Medicines Agency has partnered with eight institutions having access to real-world healthcare data to enable its DARWIN EU project to deliver real-world evidence to the EU medicines regulatory network when needed.

Improvements have been made to the second phase of an EU pilot that allows drug sponsors to obtain simultaneous scientific advice from two member states.

The European Medicines Agency and the international association of pharmaceutical inspectorates, PIC/S, say they need to make extensive changes to their guide on using computerized systems when manufacturing medicines.

The European Medicines Agency believes that a scientific guideline on clinical trials incorporating a platform design is needed because such studies are expected to play an increasingly important role in future marketing authorization applications.