EMA publishes minutes of the CVMP meeting 10-12 February
EMA publishes minutes of the CVMP meeting 10-12 February
13 February, 2015
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.
