EGA Press Release

Tuesday, 13 February 2007

LACK OF AGENCY RESOURCES DELAYING
GENERIC MEDICINES APPLICATIONS

Speaking today at the 6th Annual EGA Regulatory and Scientific Affairs Conference in Brussels, Greg Perry, Director General of EGA, praised EU regulators for the smooth implementation and running of the new Decentralised Procedure (DCP) for approving medicines in Europe. At the same time, he expressed concerns about the serious lack of resources available to Member State agencies to deal with the regulatory workload and the bottleneck in new registrations this is causing.

“The EGA has welcomed the introduction of the Decentralised Procedure,” Mr Perry said. “It is a great improvement to the marketing authorisation process compared to the older Mutual Recognition Procedure.” The DCP eliminated the first national approval step from the MRP and the associated delays. It has less ‘rounds’ of time consuming questions, and all the serious questions are raised together instead of at various times in the process.

The enormous preparatory work that went into implementing this procedure is apparent to all, and has made it the success it is today and this is recognised by EGA members. “The DCP has exceeded all our expectations”, Mr Perry said, “and demonstrates how well the MS can work together.” The fact that approximately 300 generic medicines applications have been filed under the DCP in 2006 give proof to the success of the new procedure. Fully 70% of the procedures completed last year under the DCP (40 out of 57) were for generic products.

The generic medicines industry is indeed the leading user of the DCP, and its use of the procedure will increase as patents on reference products continue to expire, companies from the New Member States extend their markets throughout the EU, and Member State governments seek a broader role for generic medicines in their efforts to ensure sustainable healthcare spending.

“So while we are happy with the new system,” Mr Perry continued, “the medicines agencies are obviously struggling to run the DCP under a serious lack of resources.” As a result, only 9 out of 27 Members States have indicated a willingness to act as the Reference Member State (RMS) for applications, and it can take up to a year to receive confirmation that a Member State will act as the RMS. This generates critical time lags in processing applications from generics companies, delaying patient access to more affordable medicines.

To resolve the situation, Mr Perry suggests a joint effort from both agencies and industry. He proposes an increase in work sharing between agencies in areas such as variations and pharmacovigilance assessment, and that repetition of assessments be avoided. He also requests full respect for the “potential risk to public health”, and the elimination of specific national requirements in favour of a more harmonised EU approach.

For industry, Mr Perry suggests companies work together on literature research for PSUR purposes and on testing patient information leaflets (PIL), as long as the agencies are willing to accept this approach. He would also ask companies to keep the agencies better informed of any changes in their plans to submit applications.

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