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1.8.2012

European Commission proposes new clinical trials regulation

The European Commission has put forward proposed new legislation on the conduct of clinical trials. The proposed regulation comprises significant amendments to the current clinical trials directive (2001/20/EC). The proposed changes seek to address criticisms expressed by patients, researchers and industry.

The new legislation will take the form of a regulation to ensure that the rules surrounding clinical trials are identical throughout the member states .

More information on this topic is available in the Question & Answer sheet prepared by the European Commission.

Clinical Trials Regulation (Finnish) (pdf)
Clinical Trials Regulation (Swedish) (pdf)
Clinical Trials Regulation (English) (pdf)

The new regulation is expected to enter into force in 2016. Work on the proposed regulation will be ongoing.

Read more:

European Commission

Further information:

Johanna Honkalammi, Senior Medical Officer, tel: (09) 4733 4491
Esko Nuotto, Head of Unit, tel: (09) 4733 4327

Fimea e-mail addresses: firstname.lastname@fimea.fi.