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Generics “held up” by EU regulator delays


Generic versions of proprietary medicines are not getting to doctors and patients as fast as they should due to delays at the regulatory stage, European manufacturers have claimed.

The European Generic Medicines Association (EGA) 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.

Speaking during the EGA’s ongoing annual regulatory and scientific affairs conference in Brussels, director-general Greg Perry praised the preparatory work undertaken by national regulators in November 2005, to implement new Decentralised Procedure (DCP).

Mr Perry said the DCP was a major improvement on the older Mutual Recognition Procedure (MRP).

However, he added: “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.”

He said the situation this year was “even worse” than last year despite 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,” Mr Perry claimed.

The EGA acknowledged that certain EU Member States, such as Germany, had 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 the national agencies tightened the rules for allocating submission dates to avoid double-booking, and considered financial penalties for companies that failed to inform authorities when an allocated date would 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”.


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