News updates from the EMA

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.

Pharmacovigilance

• 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)

Fees

• 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).

Quality

• 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).

QRD

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