EU Pharmacovigilance Group Planned

Following an ad hoc pharmacovigilance meeting in London on March 9-10, held at the request of the European Union Committee for Proprietary Medicinal products, the third meeting of the CPMP, in brussels on March 13-14, agreed on a mandate and work program for a permanent CPMP working group on pharmacovigilance. Susan Wood of the Uk Medicines Control Agency was asked to chair it.

The CPMP also agreed to hold an ad hoc biotechnology working group in London on April 6-7, and discussed the creation of a working group on quality. Ad hoc International Conference on Harmonization/ CPMP coordination meetings were held February 28 with regulatory topic leaders, and March 1 with industry experts, and final preparations were made for the ICH Steering Committee and expert groups meeting in Washington at end-March.

Three multistate applications were examined by the CPMP, in conformity with the rules applying before 1995, and three positive non-binding opinions delivered. The next CPMP meeting will be April 26-27 at the European Medicines Evaluation Agency headquarters in London, when the new conference facilities will be ready.