EGA Press Release

Thursday, 31 January 2008

EGA REITERATES LACK OF RESOURCES FOR NATIONAL REGULATORY AUTHORITIES AS MAJOR BARRIER TO NEW GENERIC MEDICINES

The European Generic medicines Association (EGA), during its 7th Annual Regulatory and Scientific Affairs Conference today in Brussels, has reiterated its plea to the National Medicines Authorities to resolve their issues of resources to ensure the rapid and efficient approval of marketing applications for new generic medicines.

Greg Perry, EGA Director General, delivered the association’s new appeal at this morning’s opening session of the conference chaired by Jytte Lyngvig, Chair of the Heads of Agencies Management Board. Speaking before an audience of senior regulatory officials from throughout Europe, officials from the European Commission and industry representatives, Mr Perry applauded the National Authorities for the enormous preparatory work they had undertaken to implement the new Decentralised Procedure (DCP) in November 2005. He recognised the DCP as a major improvement to the marketing authorisation process over the older Mutual Recognition Procedure (MRP).

Nonetheless, he continued, “The lack of sufficient resources available to the Competent Authorities has been identified as the main barrier for the industry and European consumers to benefit fully from this new procedure. The situation today”, he said, “is even worse than last year, despite the repeated warnings and detailed suggestions for improving efficiency offered by the EGA over the past two years. It constitutes a significant obstacle to the introduction of the new generic medicines onto the EU market.”

Amongst the important difficulties encountered in the new procedure, Mr Perry highlighted the significant delays involved in obtaining a date for submitting an application, the significant delays in receiving the initial assessment report and in updating assessment reports to start a repeat use (RU) MRP, and the limited availability of the National Medicines Agencies to take the lead in the procedure as the Reference Member State. The EGA welcomes the fact that new countries did start to act in this capacity in 2007, but notes that the main workload is still being covered by only four agencies. The EGA acknowledges that certain Member States, such as Germany, have indeed taken steps to increase resources, but not to the extent required to cope with the expanded workload resulting from the implementation of recent legislation (eg, assessment of paediatrics trials, transparency, PIL user testing etc).

To help alleviate the overloaded approvals process, Mr Perry suggested that the National Medicines Agencies tighten the rules for allocating submission dates to avoid double booking, and to consider financial penalties for companies that fail to inform when an allocated date will not be used.

More importantly, Mr Perry said, the National Authorities must cooperate more closely amongst themselves to increase the assessment capacity of all Medicines Agencies and to ensure the full recognition of assessments made by other Member States.

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