On 12 April 2017, the European Medicines Agency (EMA) published a new version of the External guidance on the implementation of the EMA Policy 0070 on the publication of clinical data for medicinal products for human use. Policy 0070, adopted on 2 October 2014, marks a significant step forward in the EMA’s initiatives towards increased transparency of information on medicinal products authorised in the European Union. More precisely, the policy requires the EMA to proactively publish clinical data concerning authorised medicinal products, composed of clinical reports (Phase 1) and individual patient data (Phase 2).

The External guidance relates to Phase 1 of the implementation of Policy 0070, concerning the publication of clinical reports. First published on 2 March 2016, the guidance has been revised twice to this date: in December 2016 (Revision 1) and in April 2017 (Revision 2).

The new version of the guidance clarifies the type of clinical data for medicinal products for human use to be published under Policy 0070 and especially includes the following precisions:

  1. The guidance clarifies which clinical reports should be submitted for publication. In particular, all clinical study reports (CSRs) crossreferred to within a paediatric extension or modification of indication application submitted in the context of regulatory procedures not falling within the scope of Policy 0070 will now be subject to publication. Where CSRs are crossreferred to within extension or modification of indication and line extension applications other than paediatric, only the pivotal clinical study reports submitted will be subject to publication.
  2. The guidance provides details regarding the treatment of individual patient data listings present within the CSRs that are subject to publication. While the guidance clearly states that all sections of the CSR body are subject to publication, it then establishes a distinction with respect to individual patient data listings:
    • When individual patient data listings are found in the “Abnormal Laboratory Value Listing” section of the CSR (Section 14.3.4), they can be considered as out of scope of Phase 1 of Policy 0070 and, as such, be removed from the CSR prepared for publication.
    • However, when these listings are found in other sections of the CSR, they should be anonymised rather than removed.
  3. On the other hand, in the case of applications with no patient identifiers (e.g. generic, hybrid and well-established use applications), the guidance now provides applicants/marketing authorisation holders (MAHs) with an anonymisation report template (Annex 1.13).
  4. More generally, the guidance presents a new validation checklist in order to assist applicants/MAHs when submitting clinical data (Annex 1.14).

In operation since 12 April 2017, the new version of the guidance on the publication of clinical data on medicinal products for human use thus provides applicants with further information and concrete details as to the implementation of the publication requirements of CSRs.