EFPIA urges Commission not to abandon centralised clinical trials system

Published: 12-Jul-2011

Believes a fully optional clinical trial procedure is a valid proposition


The European Federation of Pharmaceutical Industries and Associations (EFPIA) has asked the European Commission not to abandon the idea of establishing a central EU clinical trials system valid in all member states.

Commenting with its specialist section the European vaccine Manufacturers (EVM) during the ongoing review of EU clinical trials rules, EFPIA said it ‘does not agree with the Commission assessment that a central assessment is not appropriate or workable; on the contrary we continue to believe that a fully optional [EU] clinical trial procedure is a valid proposition and that it should be explored further.’

It explained that a fully optional [EU] clinical trial procedure with a single dossier submitted centrally, reviewed once and resulting in the granting of an EU clinical trial authorisation is a valid proposition.

This followed the declaration in its consultation paper by the European Commission that a central EU assessment system would not be workable because it would ‘insufficiently take account of ethical, national, and local perspectives’, and so as a result, parallel national procedures would be required anyway. Meanwhile, the number of European multinational clinical trials per year (1,200) would make centralised assessment very difficult. And very few clinical trials involve ‘more than five or six member states’ anyway.

However, if the industry association’s view does not prevail, it declared agreement with Commission suggestions for harmonising trials under the EU clinical trials directive. And it backed the idea of a single submission portal for trial results as having ‘the potential to remove some of the administrative burden on applicants’.

EFPIA said any new system should be ‘non-bureaucratic, simple and speedy, provide uniformity of conduct of multicentre trials in all concerned member states’, and ensure consistency with EU level scientific advice.

In its consultation document, the Association of the British Pharmaceutical Industry (ABPI) took a similar line on the need for an optional EU trials procedure.

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