21.01.2015 - The EMA is asking for comments on how to implement the transparency rules of EU Clinical Trial Regulation, pointing to the new clinical trial portal and database as the main instrument.
The European Medicines Agency (EMA) has turned to the public on how the transparency rules of the European Clinical Trial Regulation will be applied in the new clinical trial database. The proposal establishes a new clinical trial portal and database for the submission and maintenance of clinical trial applications and authorisations within the EU. According to the agency, this will be the key instrument in achieving transparency.
The aim of the European Clinical Trial Regulation is create an environment for clinical trials in the EU that adheres to the highest standards of safety for participants. It will also ensure that the rules for conducting trials are consistent throughout the EU. The Regulation also transforms the level of information publicly available for every clinical trial carried out in the EU – transparency on the authorisation, conduct, and results of the trial will be obligatory. It also specifies a timeline for posting results no later than 12 months after a trial’s completion or 30 days after a Marketing Authorisation Application (MAA) has been approved or withdrawn. Exceptions to the Regulation are permitted to protect personal data, commercially confidential information, and confidential communication between member states or supervision of clinical trials by member states.
Stakeholders are to submit their comments on the draft proposal by 18 February. The EMA said the EU regulation will not go into effect before 28 Ma, 2016 and will apply to all clinical trials that are registered once the Regulation is in operation.
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