Policy EMA/0070 – part 1

Maxer starts with this publication a series of short articles that are intended to illustrate the changes introduced by the rules on Clinical Trials Transparency and the operational implications that they produce for pharmaceutical companies.

The European Medicines Agency is committed to continuously extending its approach to clinical trials data transparency. The purpose is to make medicine development more efficient, to foster public scrutiny to clinical study information by the scientific community, and to develop knowledge in the interest of public health, protecting and fostering this latter, while promoting a better-informed use of medicines.

A high degree of transparency will take regulatory decision-making one step closer to EU citizens, and promote better-informed use of medicines. (…) access to clinical data will benefit public health in future”. (from EMA 0043 Policy)

This new policy serves as a complementary tool ahead of the implementation of the new EU Clinical Trial Regulation No. 536/2014 that won’t come into force, not before May 2016.

The scope

The scope of the EMA Policy on publication of clinical data for medicinal products for human use relates to proactively share study-level and patient–level clinical data, i.e. clinical reports and individual patient data (IPD), submitted under the centralised marketing authorization procedure after the 1st January 2015.

The publication procedure

The  procedure goes through two sequential phases:

  • First phase of disclosure, i.e. the publication of Clinical Reports (mod. 2.5, 2.7, and 5 of the CTD plus fd7uappendices No. 16.1.1, 16.1.2 & 16.1.), supporting centralised MAA submitted only after Jan 1, 2015, and – starting from 1.7.2015 – also line extensions (on-going)
  • Second phase, regarding the provision of Individual Patient Data (foreseen in 2016 but still to be better defined).

The procedure’s pillars

The introduction of a publication procedure for clinical reports is based on 2 pillars:

  • Terms of use (ToU), which govern the access to and use of clinical reports
  • A user-friendly technical tool allowing access to such clinical reports.

Data not covered by the scope of the policy

  • Clinical data held by EMA for MAA submitted under the centralised procedure before 1 January 2015, and for extension of indication applications and line extension applications submitted before 1 July 2015.
  • Clinical data (either data provided to EMA before 1 January 2015 or data not yet held by the Agency) submitted to the Agency for non-centrally authorised products.

These clinical data continue to be made available to external requesters on a reactive basis in accordance with the European Medicines Agency Policy on access to documents related to medicinal products for human and veterinary use – POLICY/0043 – Effective from 1° Dec. 2010.

Patient’s privacy and CCI

Methods for balancing the protection of patient’s privacy while sharing clinical trial data and topics considered potential commercially confidential information (CCI) for redaction are defined. Next articles will specifically deal with these issues.