EGA Raises Concerns Over Regulatory Workload in Approving Generics

Brussels (Feb. 13)-The European Generic Medicines Association (EGA, www.egagenerics.com) raised concerns over what it terms “the serious lack” of resources available to member states in the European Union (EU) to deal with the regulatory workload and bottleneck in new registrations caused by the new Decentralized Procedure (DCP) for approving drugs in Europe.

While welcoming the DCP, EGA raised issues over delays in the regulatory approval process. “The EGA has welcomed the introduction of the Decentralized Procedure,” said Greg Perry, director general of EGA, who spoke at the 6th Annual EGA Regulatory and Scientific Affairs Conference in Brussels in mid-February. “It is a great improvement to the marketing authorization process compared to the older Mutual Recognition Procedure.”

The DCP eliminated the first national approval step from the mutual recognition procedure and the associated delays, said EGA. This change has resulted in less “rounds of time-consuming questions, and all the serious questions are raised together instead of at various times in the process,” said EGA.

Roughly 300 generic medicines applications were filed under the DCP in 2006, according to EGA. In 2006, 70% of the procedures completed under the DCP (40 out of 57) were for generic products.

EGA said that the generic drug industry is the leading user of DCP, and its use of the procedure will increase as patents on reference products continue to expire, new member states enter the EU, and the governments of EU member states seek to increase the use of generic drugs.

To date, only nine of 27 member states have indicated a willingness to act as a Reference Member State (RMS) for applications, and EGA said it can take up to one year to receive a confirmation that a member state will act as the RMS.

To address that problem, the EGA is proposing an increase in work sharing between agencies in areas such as variations, pharmacovigilance assessment, reducing the repetition of assessments, and a move to a more harmonized EU approach. EGA also is asking companies to keep agencies better informed of any changes in their plans to submit applications.