Pharmacovigilance: GVP Updates and EMA Newsletter

Recommendation

28-30 March 2023

Global Registration and Life Cycle Management of APIs - Live Online Training
Contents of the regulatory information in the ASMF and CEP

The European Medicines Agency (EMA) has published drafts of the following revised and new modules and documents of the Guideline on good pharmacovigilance practices (GVP):

• GVP module XV (Safety Communication) with the corresponding templates. The proposed changes focus on:
  
  1) The introduction of the concept of core EU direct healthcare professional communications (DHPCs) for the situation where a common DHPC prepared at EU level may not be suitable because of differences in the DHPCs required at the level of Member States (e.g. differences in available alternative treatments) and the PRAC/CHMP therefore agree(s) on core messages only;
  
  2) The introduction of the option that one marketing authorisation holder may act on behalf of other marketing authorisation holders with a goal of disseminating one single DHPC in situations where several marketing authorisation holders are concerned;
  
  3) Adjustments of references to other GVP modules, given the recently revised GVP structure;
  
  4) Editorial improvements throughout the Module. 
  
• GVP product- or population-specific considerations II: biological medicinal products. This draft of a new GVP chapter covers aspects regarding pharmacovigilance specifically for this product group.

Comments on those drafts should be sent to EMA until 29 February 2016. You can find the drafts on the Eudralex Volume 9 GVP website under "Draft GVP chapters and annexes for public consultation". 

The chapters on product- or population-specific considerations have now been developed for vaccines and biological medicinal products. Two more consideration chapters are planned: P III Pregnancy and breast-feeding and P IV Geriatric population. These chapters are expected to be released for public consultation in the second quarter of 2016.

The EMA further released an Addendum I "Educational materials" with regard to GVP module XVI "Risk minimisation measures - Selection of tools and effectiveness indicators". The document has been in force since 16 December 2015. It describes the requirements on the creation, submission, distribution and supply of educational materials. For the safe use of some medicinal products additional information might be required. This supplementary information has to be provided in form of "educational material" in addition to SmPC (Summary of Product Characteristics) and package leaflet.

EMA Newsletter "Pharmacovigilance programme update - Issue 6 available:
In July 2014, the EMA has also started a Newsletter focussing on pharmacovigilance ("News bulletin for pharmacovigilance programme update"). With this quaterly issued  Newsletter, EMA keeps informed all marketing authorisation holders (MAHs) of the latest developments in the field of pharmacovigilance. Now, the sixth Newsletter is available. Among other things, it contains news and timetables on the following topics:

• Medical Literature Monitoring
• Database of Medicinal Products Article 57
• PSUR Repository
• Pharmacovigilance Fees
• Adverse drug reaction reporting and Signal management

Qualified Persons for Pharmacovigilance (QPPVs) who are registered in the XEVMPD database according to Article 57 of Regulation (EG) No 726/2004 receive this document directly via EudraLink. You can find the Newsletter on the website of the EMA.