European Medicines Agency proposes faster scientific advice procedure

Published: 23-Sep-2005

The European Medicines Agency (EMEA) has put out to public consultation a proposal for improving the way it provides scientific advice on new medicines.


The European Medicines Agency (EMEA) has put out to public consultation a proposal for improving the way it provides scientific advice on new medicines.

The provision of scientific advice to the pharmaceutical industry and other researchers, is one of the EMEA's main functions and these proposals form a key part of its response to the European Union (EU) strategy for improving the competitiveness of European-based research and development of medicines.

The revised procedures include earlier and greater involvement of external experts in developing advice, and a faster delivery of the advice to sponsors.

Recent EU legislation gave the EMEA a greater mandate to provide scientific advice, particularly regarding the development of new therapies, and responsibility for establishing efficient structures for the provision of scientific advice.

The EMEA says that the earlier and greater involvement of experts and assessors at all stages of the revised procedure will allow a faster response to sponsors, reducing timelines from 100 days to between 40 and 70 days. In addition, the EMEA scientific secretariat will have a reinforced role in ensuring the consistency of the advice given.

The deadline for comments on the revised procedure is 22 November 2005

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