Summer activity at the EMA sees news of paromomycin referral, PSUR contact points and a new quality Q & A

Holiday season at the EMA
21 August, 2019

Over the holiday period, there have been a few general updates as well as news of the paromomycin referral, updated PSUR submission guidance and a Q & A on manufacture of active substances.

CVMP July meeting sees completion of paromomycin referral and first scientific advice regarding NVR

The EMA has posted the press release with details of the CVMP's meeting of 16 – 18 July 2019 (Link). General news relating to regulatory affairs includes:

Referral results in suspension of paromomycin VMPs for pigs

The Committee concluded the Art. 35 referral for paromomycin VMPs for parenteral administration to pigs. The concluded that the benefit-risk balance is negative due to inadequate data to support efficacy and there is an associated risk of antimicrobial resistance development. The CVMP recommended the suspension of the MAs for the concerned VMPs.

New Veterinary Regulation

The CVMP adopted the first three scientific advice documents for implementing and delegated acts to Regulation 2019/6, which concern:

  • Variations not requiring assessment
  • Annex II – technical data requirements
  • Collection of data on antimicrobials used in animals

The adopted documents will be published on the EMA website in the coming weeks.

Pharmacovigilance: contacts for PSURs

An updated list of contact details for the national competent authorities (NCAs) for PSUR submission has been published (Link).

Monthly summary update of referrals and guidance documents

The latest monthly report on application procedures, guidelines and related documents for veterinary medicines (June 2019) is now available, summarising the veterinary activity of the EMA so far in 2019 (Link). Within this document are summaries of the current Art. 35 referrals in progress and guidance adopted in 2019.

Manufacturing of active substance: new Q & A

A new Quality Q & A has been added, regarding the use of peptones in the manufacture of active substance (Link).

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