Regulation EU No 536/2014: What’s New and What’s Changed

The European Medicines Agency (EMA)'s Clinical Trial Regulation (EU No. 536/2014), which governs research of medicinal products for human use, is scheduled to go into effect in October 2018. According to the EMA's official website, the Regulation "aims to create an environment that is favorable to conducting clinical trials in the European Union (EU), with the highest standards of safety for participants." The objective is to apply a set of rules consistently throughout the member states in the EU.

Here are six things you need to know:


  • #1 What’s New
    The EMA requires only one Clinical Trial submission to the Regulatory Authority and the Ethics Committee for the same trial and for all the involved EU countries together.

  • #1 What’s Changed
    Previously, sponsors were required to submit separate applications to the Regulatory Authority and the Ethics Committee for each EU member state in which they intended to conduct the trial.

  • #2 What’s New
    An online portal is being built for a release in 2018 where applications will be submitted, authorized and supervised through a single entry point. All recruitment and study termination information will be managed in this single portal. According to EMA delivery timeframes, the EU portal and database should be available for independent audit by August 2017 and for use by October 2018.

  • #2 What’s Changed
    Previously, different member state accepted applications through various means and methods. And Sponsors were required to submit recruitment and study termination information to each individual member state. This policy revision standardizes the application and management protocol.

  • #3 What’s New
    EMA authorities and committees now require responses within 12 days from Sponsors. Failure to provide satisfactory answers within the new 12-day timeframe will result in a rejected application.

  • #3 What’s Changed
    Previously, sponsors had an average of 25 days to reply to queries by EU authorities and committees before facing a penalty.

  • #4 What’s New
    The Clinical Trial application is now divided into two parts. Part I, consisting of common scientific documents, is assessed by all relevant member states together. Part II, consisting of state-specific or national documents, is assessed separately, and only by members of the respective member state.

  • #4 What’s Changed
    Previously, different member states have required the same information on different forms and using different procedures, resulting in a redundant application process for the sponsor. The European Commission describes the new standard application as a "harmonised procedure."

  • #5 What’s New
    Legal representatives for non-EU Sponsors is no longer stated as a mandatory requirement. Going forward, only an EU contact person for non-EU Sponsors will be required for all communications with the Sponsor.

  • #5 What’s Changed
    Previously, under the CTD 2001, Sponsors of clinical trials who are not based in the EEA were required to appoint a legal representative that is based in the EEA.

  • #6 What’s New
    By law, all information entered in the clinical trial database is publicly accessible, excepting personal identifiable information, commercially confidential information, and confidential communication between and among member states.

  • #6 What’s Changed
    Because the Clinical Trial regulation mandates a state-sponsored database, certain information about studies entered there won’t necessarily become centralized and public.

To learn more about the transition between Directive 2001/20/EC to Regulation EU No 536/2014, visit the European Commission website at here, and contact Pharm-Olam to learn specifically about how your investigational product clinical trial may be affected.