The EMA maintains a longstanding dedication to upholding the principles of Replacement, Reduction, and Refinement (3Rs) in the regulatory testing of both human and veterinary medicinal products (HMPs and VMPs). This commitment arises from the directives outlined in Directive 2010/63/EU, as well as the pressing need for enhanced tools to accurately anticipate the quality, safety, and efficacy of novel medicinal products.
The recently established 3Rs Working Party (3RsWP) operates as a collaborative body comprising members from both the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Veterinary Medicinal Products (CVMP). Its primary function is to provide guidance to these committees on all aspects related to the utilization of animals in the regulatory testing of medicines, with a specific emphasis on the application of the 3Rs principles, namely, replacement, reduction, and refinement.
In February of 2023, the 3RsWP conducted a two-day plenary meeting aimed at showcasing the Agency’s unwavering commitment to implementing the 3Rs principles in the development and assessment of human and veterinary medicinal products. The public session sought to introduce the 3RsWP’s work plan and extend an opportunity for stakeholders to offer their comments and perspectives on the activities of this working party.
Read the report here.
References
- Ema. (2023, May 22). 3Rs Working Party (3RsWP) plenary meeting – Public session on the 2023 work plan European Medicines Agency. European Medicines Agency. https://www.ema.europa.eu/en/events/3rs-working-party-3rswp-plenary-meeting-public-session-2023-work-plan
Disclaimers
- The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
- Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
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