Posted on 05 Feb 2019

Regulatory news - February 2019

Regulatory news 


The European Medicines Agency (EMA) updated the following documents in late 2018:

  • Minor update to version Rev. 2.0.1 of the guidance on format of the risk management plans accompanying GVP module V Rev. 2 (the version of 30 March 2017 is superseded)
  • Pre-authorisation procedural advice for users of the centralised procedure
  • Post-authorisation procedural advice for users of the centralised procedure
  • EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) have launched a six-month public consultation (until 31 July 2019) on draft key principles for the development of the electronic product information (ePI) for human medicines in the European Union. The product information (PI) of a medicine in the EU includes the package leaflet for patients and the summary of product characteristics for healthcare professionals. These documents accompany every single medicine authorised in the EU and explain how it should be used and prescribed. The package leaflet is currently provided in the medicine’s box and can also be found, mainly as a pdf document, on the regulators’ websites. However, digital platforms open additional possibilities to disseminate the PI electronically. This can address some of the current limitations and better meet patients’ and healthcare professionals’ needs for accessible, up-to-date information on medicines at the point of need. A report from the EMA/HMA/EC workshop on ePI which took place on 28 November 2018 and the video from this workshop are available online. For more details please see the EMA‘s press release. Stakeholders and members of the public are invited to submit comments on these key principlesvia an online form until 31 July 2019.



  1. TransCelerate
  2. PhUSE White Paper: Clinical trial transparency and disclosure: A global view 
  3. Impact of EMA Relocation to Amsterdam on RPD Activities 


1. In November 2018, TransCelerate Biopharma - an alliance among some of the world’s prominent biopharmaceutical organisations - released a clinical study report (CSR) template. 

TransCelerate’s CSR template was developed using the two “well-known standards” - ICH E3 and CORE Reference ( The EMWA-AMWA CORE Reference development team was not involved in the TransCelerate CSR template development work. 

Read our Press Release on TransCelerate’s CSR template and use of CORE Reference in its development.


Dr Sam Hamilton - Chair, CORE Reference Project

EMWA Past President, EMWA Fellow; Director, Sam Hamilton Medical Writing Services Limited

Dr Art Gertel - Strategist, CORE Reference Project
EMWA Past President, EMWA Fellow; AMWA Past President, AMWA Fellow; Principal, MedSciCom, LLC



2.This excellent PhUSE white paper provides a snapshot of the current clinical trial transparency and disclosure arena and is a treasure trove of relevant references, guidances and other resources. The paper was "developed by industry experts with the goal of highlighting the evolving global landscape of clinical trial transparency and disclosure with special focus on individual study and submission-related requirements".


3. Read this 23-January-2019 update on EMA’s relocation to Amsterdam. Note that in Annex 1 - in which EMA summarise their prioritised continued work activities in the multiannual work programme, there is no listing for clinical trial public disclosure activities.