Overview of the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs - Scientific guideline

This reflection paper provides an overview of the main tests that involve the use of animals that are required for the regulatory testing of human medicines. It also includes opportunities for further improvement in the application of 3Rs. A parallel document on veterinary medicines is also available.

Keywords: 3Rs, regulatory testing, regulatory acceptance, testing approaches, human medicines
 

Current version - under consultation

Draft reflection paper on the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs - Revision 1

Draft: consultation openConsultation dates: 13/02/2025 to 30/06/2025Reference Number: EMA/CHMP/CVMP/3Rs/742466/2015 Rev. 1

Document history

Reflection paper providing an overview of the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs - First

DraftReference Number: EMA/CHMP/CVMP/3Rs/742466/2015

Draft reflection paper providing an overview of the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs - First version

Draft: consultation closedConsultation dates: 18/11/2016 to 31/05/2017Reference Number: EMA/CHMP/CVMP/JEG-3Rs/742466/2015Summary:

The current reflection paper provides a snapshot of the testing requirements at the time of publication. It is to be expected that, over time, new testing approaches will become accepted and the tables will become out of date. In reviewing these tables the reader should remember that the fundamental responsibility of the CHMP is to ensure the quality, safety and efficacy of medicinal products and so to safeguard patient health. While the CHMP is committed to encouraging use of 3Rs approaches wherever possible, these cannot be accepted at the expense of safety and efficacy for patients.