When Approved by the European Parliament, the Regulation Will Have the Force of Law in All EU Member States and Repeal the Current Clinical Trial Directive -
On December 20, 2013, the General Secretariat released the revised proposal for a regulation of the European Parliament and of the Council of the European Union (EU) entitled, “Proposal 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.” The path to the new clinical trials regulation was initiated on July 17, 2012 when the European Commission adopted a draft proposal for a clinical trials regulation. The provisional agreement reached by the EU Committee of Permanent Representatives (COREPER) marks the conclusion of three-way (trilogue) negotiations regarding the draft regulation among the European Parliament, the Council of the EU, and the European Commission in Belgium. If approved by the European Parliament in 2014, the regulation would repeal Directive 2001/20/EC (the Clinical Trial Directive). Unlike an EU directive, which sets out requirements that must be interpreted and enacted by separate legislation in each EU Member State, the clinical trials regulation, if approved by the European Parliament, would automatically be deemed to be incorporated in each EU Member State’s law under EC Treaty (Article 249). Thus, for the first time, clinical trials of investigational medicinal products3 would be subject to identical regulation across the EU with the force of law. In addition, if enacted, the regulation would usher in substantial changes and harmonization in the processes for submission and approval of clinical trial dossiers. It would also provide new and expansive requirements for public transparency of clinical trial results.
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