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European Union: New Regulation on Clinical Trials

(Apr. 17, 2014) On April 14, 2014, a new regulation on the authorization of clinical trials was adopted at the European Union level by the Council of the EU. The European Parliament approved the regulation in December 2013. (Press Release, Council of the European Union, Council Adopts New Rules on Clinical Trials, CONSILIUM [Council of the European Union official website] (Apr. 14, 2014).) The new regulation replaces two existing Directives, 2001/20/EC and 2005/28/EC, on establishing rules for good clinical practice and on requirements for authorization of the manufacturing or importation of medicinal products for human use, respectively. (Clinical Trials, European Commission website (last visited Apr. 16, 2014).)

The old clinical trials regime has been subject to criticism by patients, researchers, and the pharmaceutical industry because of its extensive regulatory requirements, high cost, and lack of harmonization of rules for multinational clinical trials. All of these factors contributed to a decline in the number of trials conducted in the EU. It is estimated that during the period 2007-2011, the number of applications for clinical trials decreased by 25%. (Press Release, Memo/14/254, European Commission, Q&A: New Rules for Clinical Trials Conducted in the EU, EUROPA (Apr. 2, 2014).)

The new regulation establishes the uniform application of common standards governing clinical trials across the EU and aims to attract more researchers to conduct clinical trials in the EU by simplifying and expediting the authorization procedure. Under the prior legal regime, an authorization was necessary in each Member State where the clinical trial was to be conducted. (Council Adopts New Rules on Clinical Trials, supra.)

The major highlights of the regulation are:

· Clinical trials must be authorized within 60 days. If no decision is made within the deadline, authorization is considered as having been given through tacit approval.

· Decisions on applications for large-scale modifications of clinical trials must be taken within 49 days. If the deadline passes without a decision having been made, authorization is deemed to have been granted.

· One single application will be sufficient for conducting clinical trials in several EU Member States. (Id.)

A Clinical Trials Register, maintained by the European Medicines Agency, has been in operation online since 2011 and allows public access to information on clinical trials for medicines authorized in the 28 EU Member States and in Iceland, Liechtenstein, and Norway. (Clinical Trials, EU Clinical Trials Register website (last visited Apr. 16, 2014).)