It is now some two years since EU Directive 2001/20/EC, the "Clinical Trials Directive", came into force and in that time it has been evident that despite the provisions of Annex 13 to the EU GMP Guide (on GMP for Investigational Medicinal Products) there are still areas of uncertainty in application of the GMP requirements related to it. These have manifested themselves in a variety of varying interpretations in individual member states.
It is therefore to be welcomed that the EMEA has formed a joint subgroup of its GCP and GMP Inspection services to address areas where further guidance is needed on the application of the Directive.
The work plan of this Group is set out on the EMEA website (http://www.emea.eu.int/Inspections/docs/GcmPwp2006.pdf ) and gives an indication of the nature of the topics that it will consider. These will, in a number of cases, be addressed by Q&A documents, and topics for which such guidance is intended include:
- application of section 42 of Annex 13 on packaging and labelling at the investigator site and in particular the extent of QP responsibility
- content of "batch release certificates"
Any move towards clarifying and harmonising the application of the Directive across member states is welcome and will, we hope, facilitate the activities of companies carrying manufacturing materials for use in clinical trials throughout the European Union.
The outcomes of this initiative will be followed with interest.