The EMA has published the minutes of the latest CVMP meeting, which can be found here. The following general regulatory developments are noted:
- The veterinary pharmacovigilance bulletin for 2014 was adopted, noting in particular a 35% increase in adverse event reporting since 2011.
- A revised guideline was adopted for a second public consultation for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances.
- A new guideline was adopted for public consultation on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial VMPs in food-producing animals.
- A Q & A document was adopted regarding plastic containers for eye drops (for publication after adoption by the CHMP).
- Two revised VICH guidelines were adopted for EU implementation, relating to “Studies to Evaluate the Metabolism and Residues Kinetics of Veterinary Drugs in Human Food-producing Animals”:
- VICH GL48: Marker Residue Depletion Studies to establish Product Withdrawal Periods
- VICH GL49: Validation of Analytical Methods used in Residue Depletion Studies
- As of 16 February 2015, the EMA will not require a hard copy of the cover letter accompanying applications submitted via Eudralink. However, the recommended submission method for the Agency is the EMA e-submission Gateway/Web Client; for submissions via the Gateway no hard copy of the cover letter has been required since April 2014.