EC CPMP Plenary Meeting In June

At its June meeting, the European Union Committee for ProprietaryMedicinal Products adopted positive opinions on three centralized applications relating to one new active substance (Part B) for idiopathic Parkinson's disease.

The Committee also adopted two positive opinions for centralized type II variations and three positive opinions for type I variations following the type II procedures, and a scientific advice for three requests from industry. Since the May meeting, the European Commission has granted marketing authorization to Nycomed's Teslascan (mangafodipir), a paramagnetic contrast medium for MRI detection of liver lesions, the meeting heard.

The CPMP has held meetings, in part with the European Federation of Pharmaceutical Industries' Associations, to agree EU positions for the fourth International Conference on Harmonization in Brussels, July 16-18. The EFPIA presented a feasibility study by ICH industry partners on a Common Technical Document (technical data to support a marketing authorization application in the three regions) to be presented at ICH4, where establishing this as an ICH topic will be decided.