Frequently Asked Regulatory Questions about Investigational Medicinal Products

Commonly asked questions discussed at symposia, Good Manufacturing Practice (GMP) Consultative Committee meetings and others received by the MHRA GMP Inspectorate and European Medicines Agency. The Q&As should be considered carefully in relation to individual circumstances and any specific concerns should be discussed with the QP and/or relevant Competent Authority.

FAQ by European Commission: Guidance on Applying for Clinical Trials: External Link

FAQ by MHRA: Good Manufacturing Practice (GMP): Investigational medicinal products (IMP): External Link

FAQ by European Medicines Agency: Good Manufacturing Practice (GMP): Annex 13: External Link

FAQ by MHRA: Risk-adapted approaches to clinical trials implemented by the MHRA for UK trials since 1 April 2011: External Link