July and August news from the EMA sees updates on guidance for vector-borne-diseases, VICH quality and residues, antimicrobial resistance and more

The EMA has posted the press release with details of the CVMP's meeting of 17 – 19 July 2018 (Link). The following general news relating to regulatory affairs for veterinary medicinal products (VMPs) was discussed in the meeting, or has been published on the EMA website during July and August:

Quality / Chemistry, Manufacturing and Controls (CMC)

• Draft guidance: Quality of water for pharmaceutical use (not yet published)
• Draft guidance: VICH GL58 on stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV (Link)
• Adopted guidance: Q & A on the control of content of active substance in a VMP where there can be batch to batch variability in the potency of the active substance (not yet published)
• Adopted guidance: Chemistry of active substances for VMPs – this guideline is now in effect, as of 19Jul18 (Link).
• Draft guidance: Outcome of the public consultation on Q & As on the implementation of risk-based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (Link). The overview of comments has also been published, which includes input from IFAH-Europe, now AnimalhealthEurope (Link).
• There have also been a number of updated Q & As regarding active substance master file (ASMF) submissions (Link).

Efficacy

• Draft guidance: Data requirements for VMPs for the prevention of transmission of vector-borne diseases (VBDs) in dogs and cats (Link)

Antimicrobial Resistance (AMR)

• Draft guidance: Revised guideline on the assessment of the risk to public health from AMR due to the use of antimicrobial VMPs in food-producing animals (Link)
• Draft guidance: Reflection paper on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation (Link)

​Safety

• Adopted guidance: VICH GL56 on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periods (Link)

Regulatory submissions

• eSubmissions: new versions of the eAFs (v1.23) and the associated user guides are now available (Link).
• Pharmacovigilance: updated contact details for centrally authorised VMPs have been published for PSUR submissions (Link).
• The CVMP meeting dates for 2019, 2020 and 2021 have been published (Link).

Minor Use / Minor Species (MUMS)

• Four new classifications for MUMS products have been added to the summary page (Link). These relate to: musculo-skeletal system (dogs and horses); antiparasitic products, insecticides and repellents (cats and fish)

Small and Medium Sized Enterprises (SMEs)

• The latest news bulletin for SMEs, with a summary all relevant veterinary guidance and other updates for SMEs has been published (Link).