Posted on 05 Sep 2018

Regulatory News - September 2018

The EMA released its first [EMA/630246/2017] under Policy 0070 covering publications from October 2016 to October 2017. The first year of implementation of EMA’s clinical data publication policy (Policy 0070) has been productive: as of 20 Oct 2017, clinical data corresponding to 54 regulatory procedures for 50 medicines, including orphan, biosimilar and generic medicines, as well as medicines for use in children, were publicly available on the Clinical Data Publication website. This amounts to over 3,000 clinical documents, totalling more than 1.3 million pages. The majority of the clinical data relates to the approval of new medicines, but there are also clinical data for medicines already authorised and for which an extension of their clinical use has been sought. Published data attracted a total of more than 3,600 users, resulting in over 22,000 document views and in excess of 80,000 document downloads for non-commercial research purposes. 

There has been full compliance with the policy in the first year. The amount of CCI redactions in the documents published was very low, in only 0.01% of the total pages published. Applicants anonymised their clinical documents in accordance with the EMA guidance and different methodologies were applied with the aim of maintaining as much data utility as possible, as outlined in each individual anonymisation report. The next phase will involve working with applicants to improve the quality of the anonymisation reports as more experience is gained. 

Brexit preparedness: The EMA will launch the next phase of its business continuity plan on 01 Oct 2018 at the latest to safeguard core activities related to the evaluation and supervision of medicines, while intensifying preparations for the physical move to Amsterdam in March 2019 and cope with significant staff loss. The temporary cuts in activities are required because it has also become clear that the Agency will lose more staff than initially anticipated, also due to the employment rules in the Netherlands. Overall, EMA expects a staff loss of about 30%, with a high degree of uncertainty regarding mid-term staff retention. Activities impacted include: 

  • Collaboration at the international level
  • Development and revision of guidelines
  • A holding of non-product-related working parties
  • Programmes and projects, where activities in relation to project governance will be reduced in line with the reduction/suspension of projects;
  • Organisation and attendance at stakeholder meetings,
  • Clinical data publication

The EMA released for public consultation Draft questions and answers on Data Monitoring Committees (DMC) issues. The aim of this question-and-answer document is to supplement the CHMP Data Monitoring Committee Guideline (Doc Ref. EMEA/CHMP/EWP/5872/03) by providing clarification on the role and necessity for a DMC in different phases of drug development and throughout the product lifecycle, as well as with regard to the responsibilities for implementing DMC decisions. Comments should be provided using this template and sent to by 31 July 2019. 

The FDA announced the availability of a final guidance for industry entitled ''Labeling for Biosimilar Products'', which finalises the draft guidance issued on 04 Apr 2016. This guidance is intended to help applicants develop draft labelling for proposed biosimilar products. The recommendations for prescription drug labelling in this guidance pertain only to the prescribing information (commonly referred to as the package insert), except for certain recommendations pertaining to FDA-approved patient labelling (e.g., Patient Information, Medication Guide, and Instructions for Use).