EU Close To Finalizing Revised GMP And Inspection Rules For Clinical Trials
The European Commission has issued revised delegated legislation explaining new GMP requirements and inspection arrangements for investigational medicinal products that will come into play when the EU Clinical Trials Regulation kicks in.
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Two new legal acts have been adopted by the European Commission specifying updated good manufacturing practice requirements for investigational medicinal products and finished medicines. The legislation take into account recent updates to the EU rules on the safety of medicines.
The European Commission has agreed to meet with a group representing the world's leading pharmaceutical inspectorates to discuss its concerns about the commission's proposal to relax GMP guidelines for cell and gene therapy products. Industry, hopeful that the commission is finally ready to listen, is looking to share its concerns again as well.
“Thousands and thousands of people” will be using the EU clinical trials portal and database after it goes live late next year and the European Medicines Agency plans to “invest a lot” this year in teaching trial sponsors and EU member state authorities how to use the new system. The EMA is also still working on ironing out the tricky areas of user management and how to transition legacy trials.