New guidance from EMA on CMC, safety and residues, MUMS, anticoccidials, bioequivalence, varroa destructor, immunologicals, pharmacovigilance and esubmissions

The January meeting of the CVMP will take place 22nd – 24th, and will be summarised in the February Cyton news review, but since the December meeting of the CVMP, a number of documents have now been published.

Chemistry, Manufacturing and Controls (CMC): finished dosage form

• Guideline on Manufacture of the Veterinary Finished Dosage Form (Link).

Safety: mutagenic impurities and data requirements for VMPs for minor use and minor species

• Draft revised guideline on safety and residue data requirements for pharmaceutical VMPs intended for MUMS (Link).
• Guideline on assessment and control of DNA reactive (mutagenic) impurities in VMPs (Link).

Efficacy: anticoccidials, bioequivalence and Varroa destructor

• Demonstration of efficacy for veterinary medicinal products containing anticoccidial substances (Link).
• Conduct of bioequivalence studies for veterinary medicinal products (Link).
• Question and answer document on the CVMP guideline on VMPs controlling Varroa destructor parasitosis in bees (Link).

Immunologicals: allergen products and multi-strain dossiers

• Requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats (Link).
• Revised guideline (and overview of comments and Q & A) on data requirements for multi-strain dossiers for inactivated vaccines against Avian Influenza, Bluetongue and Foot-and-Mouth disease (Link).

Pharmacovigilance Q & A

• A new Q & A page is now online, regarding pharmacovigilance inspections (Link).

Other news from the EMA: 2018 highlights, regulatory science, esubmissions and EMA organisation

• Presentations are now available from “Multi-stakeholder workshop to launch consultation on European Medicines Agency (EMA) veterinary regulatory science to 2025” (Link).
• The annual review document "Veterinary medicines: highlights of 2018" has been published (Link), summarising the new EU authorisations for veterinary medicines.
• The organisation chart for the veterinary division at the EMA has been updated (Link).
• A reminder has been issued that, since 1^st January, VNeeS format is mandatory for all submissions through the national procedure (Link).