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 MHRA has approved its first drug under an international work-sharing initiative that also includes regulators from Australia, Canada, Singapore and Switzerland.
Consultancy firms must have at least five years of experience in carrying out independent GMP or GDP audits if they want to apply to become a “compliance monitor” under a new MHRA scheme to keep track of drug companies that fail to comply with GMP/GDP requirements.