Summary

EC Publications on Investigational Medicinal Products

December 9, 2015

The European Commission has recently published four (4) new public consultations on Investigational Medicinal Products (IMPs), which concern both good manufacturing practices (GMPs) and clinical trials (GCPs) for human medicinal products.  These documents are being issued as a result of the new EU Clinical Trials Regulation that requires the EC adopt delegated acts to specify the principles and guidelines of GMP and the detailed arrangements for inspection for ensuring the quality of IMPs.  The following public consultations have been issued:

  • Commission Delegated Act on Principles and Guidelines on Good Manufacturing Practices for Investigational Medicinal Products for Human Use and Inspection Procedures
  • Detailed Commission Guidelines on Good Manufacturing Practices for Investigational Medicinal Products for Human Use
  • Commission Implementing Act on Principles and Guidelines on Good Manufacturing Practices for Medicinal Products for Human Use
  • Detailed Arrangements for Clinical Trials Inspection Procedures Including the Qualifications and Training Requirements for Inspectors

GMP:  Commission Delegated Act on principles and guidelines on good manufacturing practices for investigational medicinal products for human use and inspection procedures

GMP:  Detailed Commission guidelines on good manufacturing practices for investigational medicinal products

GMP:  Commission Implementing Act on principles and guidelines on good manufacturing practice for medicinal products for human use

GCP:  Detailed arrangement for clinical trials inspection procedures including the qualifications and training requirements for inspectors.