EU Regulation no. 536/2014 implemented in Czech local regulations

EU Regulation no. 536/2014 implemented in Czech local regulations

(3. 4. 2017)

The new EU Regulation no. 536/2014 was implemented in Czech Republic regulations. Particularly, the “Drug law” no. 378/2007 Coll. was amended by law no. 66/2017 Coll. This new local regulation entered into force in March 2017 but will apply no earlier than end 2017 / 2018 when transitory period may start (Clinical trials applications submitted within this period may opted for old system driven by COMMISSION DIRECTIVE 2005/28/EC of 8 April 2005).

The new Clinical Trials legislation, which was adopted by EC on 16 April 2014 and entered into force on 16 June 2014, has taken the legal form of a Regulation. This will ensure that the rules for conducting clinical trials are identical throughout the EU. This is vital to ensure that Member States, in authorising and supervising the conduct of a clinical trial, base themselves on identical rules. The Clinical Trials Regulation aims to create an environment that is favourable for conducting clinical trials, with the highest standards of patient safety, for all EU Member States.

The main characteristics of the new Regulation are:

  • A streamlined application procedure via a single entry point, the EU portal.
  • A single set of documents to be prepared and submitted for the application defined in Annex I of the Regulation.
  • A harmonised procedure for the assessment of applications for clinical trials, which is divided in two parts. Part I is jointly assessed by all Member States concerned. Part II is assessed by each Member State concerned separately.
  • The involvement of the ethics committees in the assessment procedure in accordance with the national law of the Member state concerned but within the overall timelines defined by the Regulation.
  • Extension of the tacit agreement principle to the whole authorisation process which, without compromising safety, will give sponsors, in particular SMEs and academics, increased legal certainty.
  • Simplified reporting procedures which will spare sponsors from submitting broadly identical information separately to various bodies and different Member States.
  • Increased transparency as regards clinical trials and their outcomes.


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