ICMRA joins call to replace animal testing with alternative approaches
The International Coalition of Medicines Regulatory Authorities (ICMRA) issued a joint statement encouraging manufacturers and national control laboratories to reduce animal testing throughout the lifecycle of medicines. ICMRA also encouraged regulators to challenge any proposals that suggest using animals for batch release testing.
The ultimate, long-term goal is to completely eliminate the use of animals in general toxicity, reproductive toxicity, and carcinogenicity studies, as well as in pharmacodynamic and pharmacokinetic studies, ICMRA said. The statement was adopted by ICMRA members on 1 October and was developed by members from the European Medicines Agency (EMA), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the Irish Health Products Regulatory Authority, and Swissmedic.
“It is already accepted in most regions and countries that, in general, there is no scientific justification for conducting studies in animals for certain classes of medicines such as generic drugs or follow-on biologics (biosimilars),” said the statement. “This approach may also apply where the pharmacological effect cannot be meaningfully reproduced in any animal species, thereby limiting the relevance of animal data for human risk assessment.”
ICMRA acknowledged that replacing studies on live animals with non-animal testing methods must be approached with caution. All non-animal methods should demonstrate scientific validity. Additionally, when these methods are used as evidence to support the proof-of-concept, mechanism of action, or safety of a medicine, they must also be evaluated for their regulatory acceptability.
ICMRA also urged regulators to promote the development of non-animal tests for batch release purposes. They also encouraged regulators to challenge any proposals that suggest using animals for batch release testing. In vivo batch release testing should only be permitted when there is strong scientific justification indicating that no equivalent or superior non-animal methods are available.
To promote the use of non-animal methods, ICMRA suggested that authorities expedite meeting requests and waive fees related to providing scientific advice on qualifying non-animal-based methods.
The statement acknowledged that “different regions and countries will move at different paces to accept a transition towards drug development, licensing, and batch release without testing in animals” and encouraged drug manufacturers and regulators to work together to enable this paradigm shift.
ICMRA has observed that health organizations, including the World Health Organization (WHO), have updated their regulatory guidelines to promote the development of non-animal methods for drug development. These alternatives encompass various approaches, such as physicochemical and immunochemical methods, ex vivo techniques, and in vitro methods, which may range from simple 2D cell systems to more complex 3D cell-based systems.
Other regulators issued statements supporting ICMRA's positions, detailing their progress in developing and implementing guidelines for non-animal methods.
EMA noted that a roadmap has been established at the EU level to advance toward innovative non-animal testing methods. In June 2026, the European Commission released a roadmap aimed at phasing out animal testing for chemical safety assessments.
The agency also noted progress in reducing animal testing overall and reported that the annual number of animals used for regulatory purposes in pharmaceuticals has approximately halved from 2015 to 2023.
MHRA also issued a statement on its actions aimed at phasing out animal testing. In March 2026, the agency issued guidance to help medicine developers understand its expectations for assessing applications that use non-animal methods. Agency scientists are currently testing these methods, which include organ-on-a-chip technology, AI-driven predictive models, and 3D bioprinted tissues.
