EU-wide regulations for the conduct of clinical trials with human medicines - ensuring the protection of participants

Summary

Submission of a statement in accordance with Article 23 III GG: Negotiation goals on the EU regulation proposal: Changes regarding the protection of test participants, inclusion of ethics committees and affected member states in the approval process, reporting, requirements for the sponsor, uniform version of essential documents, practical decision-making and reporting deadlines, benefit-risk assessment, reporting obligation, definitions, entry into force among others<br /> (identical to application for BT-Drs 17/12184)<br /> <br /> Reference: Proposal for a regulation of the European Parliament and of the Council on clinical trials of medicinal products for human use and repealing Directive 2001/20/EC, COM(2012) 369 final, Council doc. 12751/12 (BR no. 413/12)

Machine translation from German. The official text remains authoritative.

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• 17/12183

  Drucksache · DE · 29 January 2013

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