Animal and Veterinary - Consultations Open Now

26th February 2024

EMA consultations open for comment now
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• Concept paper on the revision of the guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches. Reference EMA/CHMP/CVMP/452614/2023. Status: Draft. Consultation end: 28FEB2024. This guideline aims to encourage stakeholders and authorities to initiate, support and accept development and use of 3Rs testing approaches with the aim to replace, reduce and refine in vivo animal studies for human and veterinary medicinal products.
• Draft guideline on VICH GL60 Good manufacturing practice for active ingredients used in veterinary medicinal products. Reference Number: EMA/CVMP/196216/2021. Status Draft Consultation end: 25MAR2024 This document provides guidance on good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) used in veterinary medicinal products. It provides an appropriate system for managing quality and, as such, is intended to help ensure that APIs meet quality and purity standards. It applies to APIs manufactured by chemical synthesis, extraction, cell culture/fermentation, by recovery from natural sources, or by any combination of these.
• Draft guideline on live recombinant vector vaccines for veterinary use - Revision 1. Reference Number: EMA/CVMP/IWP/390313/2023.  Status Draft Consultation end: 31MAY2024 This guideline provides guidance on the data to be submitted in the marketing authorisation application for the veterinary live recombinant vector vaccines. 
• Draft guideline on data requirements for veterinary medicinal products for zootechnical purposes - Revision 1. Reference Number: EMA/CVMP/EWP/37280/2023. Status Draft Consultation end: 31MAY2024 This guideline replaces the Guideline for veterinary medicinal products for zootechnical purposes (7AE7a): Guideline for veterinary medicinal products for zootechnical purposes

 

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