EGA Press Release

Tuesday, 24 March 2009

EGA STRESSES NEED FOR URGENT IMPROVEMENTS
TO REGULATORY SYSTEM FOR MEDICINES APPROVAL

Participating at the Annual Conference of the Drug Information Association (DIA) in Berlin on 23-25 March 2009, the EGA again stressed the urgent need to optimise the regulatory system for approving generic medicines and other medicinal products which contain known active substances.

Beata Stepniewska, director of regulatory affairs, EGA said, “The generic medicines industry is facing an emergency situation with limited availability of registration slots to start the marketing authorisation procedure for its products. As generic medicines account for nearly 80% of applications in the Mutual Recognition and Decentralised procedures (MRP/DCP), the lack of sufficient resources has a significant negative impact on generic competition and patient access to generic medicines.”

This lack of resources was formally addressed by the EGA in 2007 in a detailed letter to the European Heads of Medicines Agencies (HMA) in which the EGA proposed several ways for both the Authorities and the industry to improve the efficiency of the system.

Since then the EGA notes the efforts the HMA and CMD(h) have taken to respond to this initiative of the generic medicines industry by improving their capacity to process applications for market approval. In 2008, the number of DCPs significantly increased over 2007, and additional Member States started acting as the Reference Member State (RMS)—19 in 2008 compared to 13 in 2007. Although four countries are still conducting the majority of DCPs (77% in 2008 compared to 86% in 2007), progress has been made in better distributing the workload amongst the Member States.

Similarly, the EGA welcomed the publication of the Common Request Form for RMS in a DCP. The request at the booking stage for certain information about project development was also advocated by the EGA as a way to increase the predictability of the booking system for slots. The EGA expects the simultaneous adoption of this form by all the competent authorities and the subsequent coordination of the booking process to eliminate the double booking of slots and to allow the booking of slots no more than six months in advance.

From the industry perspective, the EGA has recently provided the HMA Task Force with DCP submissions in 2009/2010 to improve the planning process. However, further HMA recommendations should not go in the direction of grouping applications according to active substance. Such action would seriously undermine competition between generic companies, especially in their effort to be the first on the market after patent expiry.

The EGA also welcomed the CMD(h) commitment to significantly reduce full parallel assessments of applications by Concerned Member States (CMS) through applying a risk-based approach during evaluation. Elimination of this practice and fuller recognition of the RMS assessment would free up significant resources and generate more capacity to assess other applications as the RMS.

Ms Stepniewska concluded that she looked forward to 2009 being a year when the HMA recommendations are implemented into regular practice by all national competent authorities and the industry. She also offered the EGA’s full cooperation in this implementation process and in further constructive dialogue.

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