KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: OCTOBER 2023

The EMA has posted the agenda and the highlights from the CVMP meeting of 3-5 October 2023. This month's meeting saw the adoption of guidelines on reporting of antimicrobial sales and use at EU level (denominators and indicators) and on the quality, safety and efficacy of VMPs designed for phage therapy. Both documents are linked below. A joint CVMP-CHMP Q&A document on use of X-ray sterilisation processes for Single Use Systems used in pharmaceutical manufacturing is expected to be published after further review by CHMP.
Minutes from the CVMP meeting on 5-7 September are also available.

EMA/CVMP

CONSULTATIONS AND GUIDELINES

• Consultation has opened on a new guideline on stability testing for variations to MAs for VMPs, in which the new classification system for variations under Regulation 2019/6 will be used;
• Consultation has opened on a new joint CMDV-CMDH draft guideline on development and manufacture of synthetic peptides;
• Comments are invited on a new guideline for calculating the dose factor to be submitted in the UPD. More information on the consultation page;
• The guideline on quality, safety and efficacy of VMPs for phage therapy has now been adopted. An overview of comments received on during consultation is also available;
• The new CVMP guideline on reporting of antimicrobial sales and use in animals at EU level has been adopted.
   

EVENTS

• EMA will host an Academia Info Day on 10th November 2023. The Agenda and instructions on how to register can be found here;
• EMA held a focus group meeting on veterinary pharmacovigilance reporting in poultry on 11th October (invitation only). More detail and the draft agenda are available on the event page;
• A focus group meeting on veterinary pharmacovigilance reporting in aquaculture will take place on 22nd November (also invitation only). More detail and the draft agenda are available on the event page.

The recordings and presentation slides from the SPOR webinars that took place in October are now available for:

• Substance Management Service (SMS);
• Referentials Management Service (RMS);
• EMA Account Management;

• Service Desk for SPOR.

   

Regulatory and reference

• The CVMP have adopted an opinion recommending inclusion of sodium salicylate for poultry other than turkey in Table 1 (allowed substances) of the Annex to Commission Regulation (EU) No 37/2010;
• A version 2 of the release notes for UPD version 1.6.34 was published on 3rd October;
• Two new CVMP recommendations on limited market classification and eligibility for authorisation under Article 23, according to target species and therapeutic area, were added in October - see the summary page;
• The EMA’s 2023 mid-year report (January to June) has been published;
• Sales trends for antimicrobial VMPs have been reported for Sweden and Czechia. A version 4 of the ESVAC surveillance and reporting protocol has also been published this month.
   

HMA/CMDV

• A revision 4 of the CMDv Best Practice Guide for VNRAs has been released.
• A revision 1 of the CMDv Best Practice Guide for VRAs has been released.
• The clock start dates for DCP and for MRP-SRP in 2024-2025 are now available.