EGA Press Release

Wednesday, 28 January 2009

MEB—EGA INFO DAY: ONGOING JOINT COOPERATION
TO MEET GROWING EXPECTATIONS

The Medicines Evaluation Board of the Netherlands (MEB) and the EGA held the first MEB-EGA Information Day on Wednesday, 28 January, the second in 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, EGA, reminded participants that generic medicines made up nearly 85% of applications in the Decentralised Procedure (DCP) and 70% in the Mutual Recognition Procedure (MRP) in 2008.

“The MEB”, said Mr Perry, “is a key agency for our industry. The EGA appreciates the MEB’s contribution to the European regulatory system, especially as a leading agency in the approval process via the DCP and MRP. The EGA commends the MEB for its efforts in handling around 12% of completed DCPs and 29% of completed MRPs in 2008. This is particularly important in the context of EU level discussions on the lack of resources to process applications for market approval.” Similarly, the involvement of MEB staff in various discussion fora, its lead on several European projects, and active participation in twinning projects is well appreciated by the European generic medicines industry.

Despite its important role in the European marketing authorisation procedures, the MEB is also facing problems of capacity to fully cope with all regulatory challenges. In light of this situation, the Information Day was designed to clarify a number of regulatory aspects related to the MEB’s role as the Reference Member State (RMS), to the optimisation of the MA process, and to the MEB’s plans for implementing the eCTD and the new portal. The MEB has also communicated to the industry on major issues related to the assessment of Module 3 of the dossier.

A special session of the Info Day was dedicated to the communication on generic medicines including patients’ expectations related to information on generic medicines and the MEB policy on providing this information.

Bogin (Dutch Generic Medicine Association), a full member of the EGA and active participant in the days proceedings, stated its support for the MEB’s view on the importance of generic medicines as formulated in its Strategic Business Plan 2009-2013. Bogin hopes that through better cooperation between all EU National Competent Authorities and by optimising current processes, MEB’s regulatory capacity will be increased to meet the demand of the generic medicines industry. Bogin hopes the problem of delays for approvals will be solved well before 2011.

Mr Perry ended his remarks by also welcoming the MEB’s Strategic Business Plan, wishing the MEB success in its implementation in benefit of public health protection and patient access to affordable generic medicines.

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