Animal Health regulatory news in August 2021
Several scientific guidelines have been adopted by the EMA/CVMP since our last news update. These are updated to be in line with terminology and definitions in the new VMP-Reg, with the scientific content unchanged:
- Conduct of bioequivalence studies for VMPs. Revision 4, due to come into effect in January 2022;
- Statistical principles in clinical trials for pharmaceutical VMPs (Rev. 1);
- On the demonstration of palatability/voluntary acceptance of oral dosage forms (Rev. 1);
- Target animal safety and efficacy guidance on VMPs intended for use in farmed fish (Rev. 1);
- Dossier requirements for anticancer medicinal products for dogs and cats (Rev. 1);
- Guidelines on specific efficacy requirements for ectoparasiticides in sheep and in cattle (both Rev. 1);
- For VMPs used in the control of Varroa destructor parasitosis in bees (Rev. 1);
- On the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats (Rev. 4).
CVMP have drawn up a reflection paper on promoting the authorisation of alternatives to antimicrobial veterinary medicinal products in the EU. The paper defines what these alternatives may be, and recommends co-operation within the EU agencies and national authorities to improve support for development of such products.
- Issue 6 (July) of the EMA's VMP-Reg Highlights newsletter is available to view and download;
- The EMA has published pre-authorisation Q&A reference information, in line with the new VMP-Reg. Further information will continue to be published on this page;
- The EMA's SME Office Newsletter for July has also been published, which contains a round-up of regulatory news of relevance to smaller enterprises;
- There was a Union Product Database (UPD) release note for July; the present version of the UPD only allows National Competent Authorities (NCAs) to upload data;
- EMA will host a web seminar to 'walk through' use of the UPD. The free training event will take place on 15th September 2021 (register here by 14th);
- EMA monthly reports on VMPs for May and June were also published.
A handful of key procedural guidance documents were updated and re-issued, and have been published on the HMA website:
- The ‘clock start’ dates for the second assessment phase of Decentralised Procedures in 2022 have been confirmed;
- A 2021 version of the MRP/DCP Marketing Authorisation National Phase requirements summary is now available;
- The spreadsheet of addresses for delivery and other contact points at the EU Competent Authorities, and the Best Practice Guide for processing the SPC and Labelling text in MRP and DCP, have been updated.