EMEA publishes Strategy Paper on 'Acceptance of Clinical Trials conducted in third Countries'

The European Medicines Agency (EMEA) has set out its strategy in relation to the acceptance, as part of a marketing-authorisation application, of clinical trials conducted in third countries. The purpose is to reinforce the EMEA’s contribution to assuring that trials carried out in third countries have been conducted in accordance with the required good-clinical-practice and ethical standards.

A three year plan of activities has been set up covering for example:

• Recommendations for the development of new medicinal products and the conduct of clinical trials
• Protocol assistance and scientific advice
• Paediatric Investigation Plan (PIP)
• Pre-submission phase
• Inspection

For further details see: EMEA strategy paper

Source: EMEA

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)