Clinical Trials Regulation EU No 536/2014 – What does this mean for you?

When the Clinical Trial Regulation (No. 536/2014) comes into effect in 2018, there will be a major change on how clinical trial applications are submitted and how clinical trials are conducted in the EU.

The goal of the new Regulation is to create an environment that is favourable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information.

 

Below you will find a brief summary of the changes:

Directive 2001/20/EC (Current)

  • Multiple submission for one trial (1 submission per each MS)
  • Double submission with a MSC: to NCA and EC
  • Individual assessment by Each MSC with no IT collaboration tool available
  • No Single MSC decision (NCA and ECs)
  • Limited EudraCT data availability to the public

Regulation 536/2014 (New)

  • Single e-submission to all MSCs
  • Harmonised dossier for one trial and
  • e-submission of structured data and documents by MSCs
  • Specific timeline
  • Joint assessment for PART I  facilitated by collaboration tool
  • Single MSC decisions
  • Single web-based EU portal
  • Distribution of the burden among users
  • View all CT relation information

 

Transition period (3 years) Directive 2001/20/EC (current) to Regulation 573/2014

  • Starts when Regulation becomes applicable (~ Oct 2018)
  • 1st Year: Clinical Trials can be submitted under old/current (Directive) or new (Regulation) system
  • 2nd & 3rd Year: Trials authorised under old system can remain under that system, New/initial Clinical Trials should comply the Regulation System
  • All Clinical Trials to switch to the Regulation 3 years after implementation (~ Oct 2021)

 

Typical Documents to be submitted:

  • Part I: Cover letter (very important), EU AF, Protocol, IB, GMP compliance documents, IMPD, Auxiliary Medicinal Product Dossier, Scientific Advice, PIPs, and labelling, proof of payment, etc.
  • Part II: Recruitment arrangements, SI/ICF/ICF procedure, suitability of the investigator, suitability of the facilities, proof of insurance cover or indemnification, financial and other arrangement, proof of payment, etc.

 

Part I Timetable Coordinated assessment (also applies to Mono-national Clinical Trials)

  • Day 0: Validation
  • D26: Draft Part I Assessment Report made available by the RMS (reporting MS) to the CMS
  • D38: All CMS share considerations
  • D45: RMS finalises the Part Assessment Report
  • D57: Sponsor submits response (w/n 12days)
  • D69: Co-ordinated assessment between MSs (12 days)
  • D76: RMS files conclusion (7days)

 

Part II Timetable National evaluation

D0: Validation

D45: Final assessment report from each MSC submitted

D57: Sponsor submits response

D76: Final assessment by the MSC shall be performed (w/n 19 days)

Submission of Part I and II in parallel (recommended) or submission of Part I followed by Part II (not less than 2 years after Part I)


Important Notes:

  • New MSs can only be added after the notification date of the initial authorisation decision
  • Withdrawal of MS: the whole application has to be withdrawn and resubmitted

Transparency:

EU Database will be publically accessible by default, with exceptions justified on any of the following grounds

  • Protection of personal data
  • Protection of commercially confidential information in particular taking into account the MA status of the medicinal product, unless there is an overriding public interest in disclosure
  • Protecting confidential communication between Member State in relation to the preparation of the assessment report
  • Ensuing effective supervision of the conduct trial Member States

 

Where can I find more information?

Information on Clinical trials – Regulation EU No 536/2014, General information, Guideline EU

Clinical Trial Portal and Database, Transparency, Safety reporting, Clinical trials conducted outside the EU, Contact points can be found here: https://ec.europa.eu/health/human-use/clinical-trials/regulation_en

 

We can help…

Ivowen Limited are fully equipped to submit for Clinical Trials Applications on your behalf. Please contact us for more information and for support of your dossier compilation or updates.

 

Written by: Fiona Downey

Posted in Clinical trials, Legislation updates, Pharmacovigilance, Regulatory Affairs and tagged , , .