Veterinary antimicrobials in the spot-light, PRRSV vaccine recombination event and other news from the EMA

PRRS vaccine recombination Denmark EMA news
17 December, 2019

The EMA has posted the press release with details of the CVMP's meeting of 3 – 5 December 2019 (Link). General news, not relating to specific products, includes notification of a new referral for VMPs containing tylosin for use in pigs, an update on the classification of antibiotics, VICH guidance on stability testing and news of a recombination event between two live attenuated PRRSV type 1 vaccine strains, leading to clinical signs of PRRS in Danish pigs.

These items and other updates from the EMA posted in the last month are discussed in more detail below.

Clinical disease in pigs following PRRSV vaccine recombination event

A recombination event has occurred between two live attenuated Porcine Reproductive and Respiratory Syndrome virus (PRRSV) type 1 vaccine strains leading to a recombinant strain that has been associated with clinical signs of disease in PRRS-naïve herds in Denmark. The CVMP meeting minutes report the recommendations concerning use of such vaccines.

The New Veterinary Regulation (NVR): veterinary antimicrobials and MUMS

The EMA has now published the CVMP’s concept paper for the revision of scientific guidelines on MUMS/limited markets for VMPs, which takes into account the new provisions concerning limited markets in the NVR (Link).

Following the mandate from the Euroepean Commission, the EMA has now published its advice on the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans (Link). Also relating to this, there is an open call for data, in the form of a questionnaire on cascade use of antimicrobials in animals and any scientific evidence of an impact on public and animal health (Link). This relates to the implementation of the NVR, specifically Article 107(6) which makes provisions for a list of antimicrobials that may not be used under the cascade, or may only be used subject to certain conditions.

Also on the subject of antimicrobials, but independent of the activities relating to the NVR, the CVMP has adopted the Antimicrobial Advice ad hoc Expert Group (AMEG) update of the scientific advice on the categorisation of antibiotics in the EU. The updated advice and comments received during the public consultation process will be published on the EMA website after adoption by the CHMP.

Article 35 (community interest) referrals for veterinary antimicrobials

The CVMP concluded the Article 35 referral for VMPs containing tylosin presented as solutions for injection for intramuscular use in pigs. The Committee agreed that the maximum injection volume per site and the withdrawal periods for pig meat and offal should be amended to provide assurance for consumer safety. Full details will be published on the EMA website in the coming weeks

Now available on the EMA website are the details of two previously concluded referrals. The first of these concerns VMPs containing tylosin presented as solution for injection to be administered to sheep (Link), where the CVMP also concluded that the maximum injection volume per site and the withdrawal periods for sheep meat, offal and milk should be changed.

The second referral concerned VMPs containing paromomycin to be administered parenterally to pigs (Link), where the outcome was that all such VMPs should be suspended, due to inadequate data supporting their use in pigs and the possibility of bacterial resistance.

VICH guidance on stability testing

The Committee adopted the guideline VICH GL58 on stability testing of new veterinary drug substances and medicinal products in Climatic Zones III and IV (Link).

Other news from the EMA

EMA event announcement: the third international awareness session on science and regulation for animal health and welfare, public health and the environment will take place 2 – 3 April 2020; registration is now open (Link).

With the EMA moving to its final location in Amsterdam Zuidas, the Agency has issued an orientation guide for industry (Link).

The latest monthly report (October 2019) on application procedures, guidelines and related documents for veterinary medicines is now available (Link).

The CVMP Work Plan for 2020 has also been published (Link). This includes plans for the CVMP’s activity with respect to the implementation of the NVR, giving an indication of the scale of this project for the regulators.

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