Dose review and adjustment of established veterinary antibiotics in the context summary of product characteristic (SPC) harmonisation - Scientific guideline

The Committee for Medicinal Products for Veterinary Use (CVMP) started a pilot project on dose optimisation of established veterinary antibiotics to which AnimalhealthEurope (formerly IFAH Europe), and the European Group for Generic Veterinary Products (EGGVP) were invited to provide anonymised data. The results of this project are for consideration by the CVMP for possible future work on the subject.

Keywords: antimicrobial resistance (AMR), summary of product characteristics (SPC), Dose optimisation, pharmacokinetic/pharmacodynamic (PK/PD) modelling, target animal safety (TAS), withdrawal periods (WP) and the environmental risk assessment (ERA)

Current version

Reflection paper on dose review and adjustment of established veterinary antibiotics in the context of SPC harmonisation - First version

AdoptedReference Number: EMA/CVMP/849775/2017

Document history

Overview of comments received on ''Reflection paper on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation"

AdoptedReference Number: EMA/CVMP/117410/2019

Draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation - First version

Draft: consultation closedConsultation dates: 27/07/2018 to 31/01/2019Reference Number: EMA/CVMP/849775/2017Summary:

Established veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance. Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the consumer of animal produce, or the environment. This may reduce product availability, which could have a negative impact on antimicrobial resistance development. At the same time, the principles for ethical use of animals in medicine testing encourage alternatives to the use of animals in the testing of medicines. Therefore, the CVMP has launched a pilot project to develop and test desk-based methodologies to optimise the dose of established veterinary antibiotics. The resulting reflection paper is available for public consultation until 31 January 2019.