Progress at EMEA's Quality Working Party on clinical trials guidelines; industry input

The European Medicines Agency (EMEA) has just released details of the discussions earlier this year on the Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials by the Quality Working Party. The focus of the last meeting was the first pharmaceutical industry comments and to ensure a transparent finalization of the guidelines, explained Rapporteur Susanne Keitel.

Dr Keitel added that the meeting's intention was only to discuss those comments which the QWP has not taken into consideration in order to better understand why the interested parties, which included representatives of the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Association of the European Self-medical Industry (AESGP)and the European Generic Medicines Association (EGA), had made them.

EFPIA concerns