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UK MHRA Guidance: Clinical Trials in the UK: Quality, Risk Proportionality, GMP, and Radiopharmaceutical IMPs
The UK regulatory landscape for clinical trials is undergoing a significant transformation with the implementation of updated Medicines for Human Use (Clinical Trials) Regulations, effective from 28 April 2026. These changes emphasize quality by design, risk-based approaches, and strengthened manufacturing standards, ensuring both participant safety and data integrity. Guidance: Clinical trials for medicines: Guidance on Quality and Risk Proportionality Scope This guidance ap

Sharan Murugan
Mar 292 min read


EMA Guidance: e-Submission of Information on IMP in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
The European Medicines Agency (EMA) last Wednesday released an updated guidance on the electronic submission of information on...

Sharan Murugan
Mar 25, 20242 min read


EMA Guidance: Electronic Submission of Information for Investigational Medicinal Products in XEVMPD
Recently (14 February 2024) the European Medicines Agency released updated (annotated) guidance on "Guidance on the electronic submission...

Sharan Murugan
Feb 17, 20242 min read
