EU launches clinical trials consultations

Published: 22-Aug-2002
Regulatory


A series of rounds of public consultation has been launched by the European Commission on detailed guidelines for clinical trials on medicinal products. These include rules on good clinical practice, ethics committee procedures, authorisation requests, making amendments to applications, and guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use.

Brussels is also consulting on the use of the EU's clinical trials database, Eudract, and guidance on the European database of suspected unexpected serious adverse reactions, a module of the Eudravigilance database. And the Commission is consulting on the need for an EU law on human tissue engineered products.

Comments are required before 2 October and should be sent to julia.dunne@cec.eu.int.

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