MHRA joins global regulators in call to advance alternatives to animal testing

The MHRA has today joined international medicines regulators in a joint statement calling for alternatives to animal testing throughout the lifecycle of human medicines to be advanced and implemented, wherever and as soon as possible.

The statement, from the International Coalition of Medicines Regulatory Authorities (ICMRA), was developed by the European Medicines Agency (EMA), the MHRA, the Irish Health Products Regulatory Authority and Swissmedic, and has been adopted by the ICMRA plenary.

It sets out the long-term goal of replacing animal testing at every stage of a medicine’s lifecycle, from initial screening and early development, through non-clinical testing, to licensing and post-authorisation activities.

Recognising that the greatest reduction in animal use would come from adopting non-animal methods for batch release testing, ICMRA also calls on regulators to:

The MHRA previously released guidance to help medicines developers understand what it requires when assessing applications that rely on non-animal methods, known as New Approach Methodologies (NAMs).