EMA Helps Trial Sponsors Categorize IMP Changes Under New Rules
EU CTR Introduces Concept Of Non-Substantial Changes Relevant For Supervision
The European Medicines Agency is inviting feedback on changes to two guidelines that will help trial sponsors correctly classify quality-related changes to their investigational medicinal products as per the requirements of the EU Clinical Trial Regulation.
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A simplified process for registering and evaluating clinical trials promised by the EU Clinical Trial Regulation is finally set to become a reality.
The UK medicines regulator has made changes to its guideline on pharmacovigilance procedures to ensure it can continue receiving all necessary safety information in a timely manner now that it has left the EU. It has also explained the safety reporting procedures for products marketed in Northern Ireland, which are still governed by EU medicines regulations.
Changes to an ICH guideline could help drug companies that are being deluged with post-approval safety information to cut down on noisy, low-value data.