Our recent post on future changes to the EU Clinical Trials Directive (2001/20/EC) had several readers inquire about the nature of these possible changes.
First things first: nothing has been decided yet.
Last fall, the European Commission DG Enterprise Pharmaceuticals unit released a public consultation paper [PDF link] on the assessment of the functioning of the EU Clinical Trials Directive. Stakeholders were invited to submit their responses by January 2010 deadline for submissions.
Industry then responded with its views of the current Directive. Here are two random examples from The Institute of Clinical Research [PDF link] and the Deutsche Gesellschaft für Hämatologie und Onkologie [PDF link].
As a next step, the Commission will consider these responses and either make amendments to the Directive or draft a new regulation to replace the Directive. More details should become available in the summer of 2010.
For more reading on clinical trials, take a look at these recent articles:
- Clinical trial agreement more important as research goes global
- Back translations - useful or waste of time?
- Insurance for international clinical trials
- Global clinical research - unethical or business necessity?
ForeignExchange Translations provides specialized medical translations for clinical research - from patient recruitment to ICFs to diaries, ForeignExchange supports sponsors in 40+ languages. Contact us for more information.