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出自识林

2012-10-11 EMA

Commission Guideline — Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006

This guidance document sets out aspects of the implementation of Article 57, third subparagraph of Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing the European Medicines Agency, and of Article 41(2) of Regulation (EC) No 1901/2006 on medicinal products for paediatric use.

It addresses the posting and publishing of result-related information relating to clinical trials, thus implementing the EU legislation aiming to make the results of clinical trials publicly available — a policy aim which is maintained in the proposal of the Commission for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. This guidance document also gives guidance as to how non-compliance and factual inaccuracy are addressed.

This guidance document completes the following Commission guidance documents:
— Guideline 2010/C82/01 on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and declaration of the end of the trial (hereinafter 'detailed guidance CT-1') , and in particular Section 4.3 thereof,
— Guideline 2008/C168/02 on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004, and in particular Sections 3 to 5 thereof, and
— Guideline 2009/C28/01 on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (EC) No 1901/2006, and in particular Sections 3.2 to 3.4 and Section 5 thereof.

Those Commission guidance documents had been further detailed by two implementing technical guidances published in 'EudraLex — the rules governing medicinal products in the European Union' on the 'List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006' and the 'List of fields contained in the "EudraCT" clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004.'

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