News updates from the EMA

9 March, 2017

In addition to the CVMPs February meeting report (Link), the EMA has published various other updates:

Anthelmintic resistance

  • Veterinary focus group meeting with stakeholders (13 June 2016) – revision of the reflection paper on anthelmintic resistance (Link). The full set of presentations from the meeting is now available.


  • The contact details and national requirements for the distribution of PSURs have now been published (Link).

New Q & A documents

  • GMP guide Part II, Q & A #12 – What are the GMP requirements to be applied to the formulation of biological active substances with excipients, when described in the active substance section of a registration dossier? (Link)
  • Type IA variations Q & A #15 – What is considered to be a non-significant in-process control or specification parameter? (Link)


  • The European Commission is currently in the process of adopting a regulation adjusting the fees payable to the Agency by 1.2% in line with the 2016 inflation rate (Link).


  • The concept paper on the need for revision of the note for guidance on quality of water for pharmaceutical use has now been published for public consultation (Link).


  • The CVMP and CMDv have now published the revised QRD product information (PI) template v.8.1 (Link). 
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