Guidelines

There are a number of guidelines further specifying various aspects of clinical trials.

These guidelines have been published by various bodies:

• By the European Commission: In this case, they are published in EudraLex - Volume 10.
• By the European Medicines Agency ("EMA") These guidelines concern in particular:
  • Inspection procedures and guidance for GCP inspections conducted in the context of the Centralised Procedure.
  • Requirements relating to the quality, safety and efficacy of products, as well as specific types of products. See EudraLex - Volume 3.
• Moreover, the Heads of Medicines Agencies have established a Clinical Trials Facilitation Group ("CTFG") (in which the Commission and EMA are observers), in order to discuss ongoing technical issues.

The guidelines for the application of Clinical Trials Directive can be found here.

The relevant guidelines and recommendations are now being revised and updated to be in line with the changes and requirements of the Clinical Trials Regulation.