Healthy Skepticism Library item: 12722

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Publication type: news

Generics are being held up by regulatory agencys, claims EGA
PharmaTimes 2008 Feb 1
http://www.pharmatimes.com/worldnews/article.aspx?id=12769&src=EWorldNews

Full text:

Copycat versions of branded medicines are not getting to doctors and patients as rapidly as they should because of delays at regulatory agencies, Europe’s generics drugmakers have claimed.

The European Generic medicines Association (EGA), during its annual regulatory and scientific affairs conference in Brussels, is again asking national authorities “to resolve their issues of resources to ensure the rapid and efficient approval” of marketing applications for new generic medicines.

Greg Perry, the EGA’s director general, praised “the enormous preparatory work” national regulators undertook to implement the new Decentralised Procedure (DCP) in November 2005, saying it is a major improvement to the older Mutual Recognition Procedure (MRP). However he added that “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”.

Mr Perry added that “the situation today 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 European Union market”, he claimed.

The EGA said it acknowledges that certain member states, such as Germany, have taken steps to increase resources, “but not to the extent required to cope with the expanded workload resulting from the implementation of recent legislation”, such as assessment of paediatrics trials and transparency”.

To help alleviate the problem, Mr Perry suggested that the national 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 concluded, the 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”.