It appears to have been a frantically busy couple of months at the EMA, with new guidance covering everything from anticoccidials to allergen products, multi-strain dossiers to mutagenic impurities and SMEs to regulatory science. However, maybe the Christmas spirit is winning through, with the latest QRD template including an approved pictogram for reindeer.
December meeting of the Committee for Medicinal Products for Veterinary use (CVMP)
The EMA has posted the press release with details of the CVMP's meeting of 4 – 6 December 2018 (Link). Below are summarised the guidelines and draft guidelines which were adopted by the Committee.
Chemistry, Manufacturing and Controls (CMC): sterilisation
- Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container.
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.
- Guideline on assessment and control of DNA reactive (mutagenic) impurities in VMPs.
Efficacy: anticoccidials, bioequivalence and Varroa destructor
- Draft revised guideline for the demonstration of efficacy for VMPs containing anticoccidial substances.
- Revised guideline on the conduct of bioequivalence studies for VMPs.
- Question and answer document on the CVMP guideline on VMPs controlling Varroa destructor parasitosis in bees.
Immunologicals: allergen products and multi-strain dossiers
- Draft guideline on production and control of allergen products for use in animals.
- 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.
Antimicrobial resistance (AMR)
- Draft scientific advice on the preliminary risk profiling for new antimicrobial medicinal products.
None of the above mentioned documents were available at the time of going to print, but they will be published on the EMA website in the coming weeks.
In addition to the minutes of the December CVMP meeting, a large number of other documents have also been published by the EMA during November and December, as discussed below.
CMC: elemental impurities, ASMF and quality of water
- Draft reflection paper on risk management requirements for elemental impurities in VMPs (Link).
- Implementation of risk assessment requirements to control elemental impurities in VMPs (Link).
- Guideline on Active Substance Master File (ASMF) Procedure (Link).
- Draft guideline on quality of water for pharmaceutical use (Link).
Regulatory submissions: EudraVigilance, EMA monthly report, pictograms and SMEs
- EudraVigilance Access Policy for Medicines for Veterinary Use - revision 1 (Link).
- Monthly report on application procedures, guidelines and related documents for VMPs (Link).
- QRD guidance on the use of approved pictograms on the packaging of VMPs – now with Camel, Fox, Pigeon and Reindeer (Link).
- Updated Q & A (Link): When shall I submit mock-ups and/or specimens?
- News bulletin for small and medium-sized enterprises (Link). Updates and information on VMPs and Brexit.
Safety: Maximum Residue Limits (MRLs)
- Updated Q & As (Link):
- When is a MRL required?
- What is the procedure for establishment of MRLs?
- Updated: Dossier requirements for submission of marketing authorisation and MRL applications to the EMA and to members of the CVMP (Link).
Antimicrobials: off-label use and environmental considerations for AMR
- Reflection paper on off-label use of antimicrobials in veterinary medicine in the EU, with overview of comments (Link).
- Draft reflection paper on AMR in the environment: considerations for current and future risk assessment of VMPs (Link).
Other news: 3Rs, gentamicin for horses and regulatory science workshop
- Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken and overview of comments (Link).
- Opinion and assessment report of the CVMP regarding VMPs containing gentamicin for parenteral administration to horses following Article 30(3) referral (Link).
- The EMA held a workshop “advancing regulatory science to 2025 for veterinary medicines” on 6th December, by invitation only. Details of the event and the agenda can be found on the EMA website (Link).