EGA Press Release

Thursday, 5 June 2008 | Brussels

AFSSAPS—EGA INFO DAY: ONGOING JOINT
COOPERATION TO MEET GROWING EXPECTIONS

The AFSSAPS—EGA Information Day—held on Wednesday, 4 June—is the first of a series of encounters between the national medicines authorities and the European generic medicines industry aimed at establishing stronger lines of communications and improving overall efficiency in the approval process for generic medicines. It forms part of an on-going EGA policy to increase cooperation with individual agencies to ensure that the authorisation of generic medicines functions well and prospers. Greg Perry, director general of EGA, reminded participants that generic medicines made up nearly 80% of applications in the MRP/DCP procedures.

“France”, said Mr Perry, “is a key agency for our industry and a growing market for generic medicines. The EGA recognises and appreciates the work being carried out by AFSSAPS and the recent reforms it has undertaken to improve its capacity to process applications for market approval.” Faced with limited resources and serious restrictions on hiring new staff to meet workloads, AFSSAPS has been working to re-engineer their internal organisation and rethinking operations to give greater priority to activities designed to provide greater added value to public health.

As a major medicines agency, AFSSAPS is also subject to a number of increasing expectations. National applications form the largest volume of agency’s work, and AFSSAPS also contributes to the centralised procedure, while operating and coordinating DCP/MRP. In addition, workloads have increased as a result of the new pharmaceutical legislation.

The Information Day was designed to clarify a number of regulatory and legal aspects related to the French implementation of this legislation. Specific points for discussion included the definition of a generic medicine, the interpretation of the Global Marketing Authorisation, disharmony in SmPCs, usage patents, and the European Reference Product.

The EGA welcomed AFSSAPS’ commitment to taking a greater future role as a Reference Member State (RMS) in approving generic medicines under the decentralised and mutual recognition procedures. Mr Perry finalised by welcoming the HMA strategic initiative to solve the current problem of resources for assessing applications, and offered AFSSAPS’ director general, Mr Jean Marimbert, the EGA’s full cooperation during the French Presidency of the Council of the European Union.

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