EMA - Veterinary Scientific Guidance Update

4th October 2024

EMA - Veterinary Scientific Guidance Update

New:

• Draft guideline on risk management requirements for elemental impurities in veterinary medicinal products - Revision 3. Reference Number: EMA/CVMP/426245/2023. Status: Draft Consultation end 31JAN2025.

Summary: This guideline replaces the Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products, EMA/CVMP/QWP/153641/2018 and the Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products, EMA/CVMP/QWP/631010/2017-Rev.2

Awaiting finalisation: 

• Concept paper on the revision of the guideline on dossier requirements for anticancer medicinal products for dogs and cats. Reference Number: EMA/CVMP/EWP/259765/2024. Status Draft Consultation end 31OCT2024.
• Concept paper on the revision of the guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees. Reference Number: EMA/CVMP/EWP/247519/2024. Status Draft Consultation end 31OCT2024.
• Concept paper for the revision of the guideline on the conduct of bioequivalence studies for veterinary medicinal products – Revision 4. Reference Number: EMA/CVMP/256158/2024. Status Draft Consultation end 31OCT2024.
• Concept paper on the revision of the guideline on user safety for pharmaceutical veterinary medicinal products – Revision 1.  Reference Number: EMA/CVMP/SWP/564774/2023. Status Draft Consultation end 31OCT2024
• Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Revision 2. Reference Number: EMA/CVMP/627/2001 Rev.2. Status Draft Consultation end 31OCT2024.

View all here: Open consultations | European Medicines Agency (europa.eu)

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