Regulatory round-up: 13 October 2025

Across the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) pushed two pace-setting moves: trial approval times are now halved to 41 days thanks to AI-supported and risk-proportionate reforms; and, six months early, MHRA with the National Institute for Health and Care Excellence (NICE) opened “aligned pathway” early-adopter slots so licensing and value decisions can publish together.

In the Asia-Pacific region, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) published an action plan to embed artificial intelligence across reviews, safety and day-to-day operations, while Australia’s Therapeutic Goods Administration (TGA) brought an October legislative amendment into force to streamline testing authorities. Singapore’s Health Sciences Authority (HSA) issued a retail-level recall of memantine (Cognimet 10 mg) over quality findings.

In Europ           e and Canada, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) posted its October meeting highlights. The Italian Medicines Agency (AIFA) approved reimbursement for crovalimab (Piasky) and acoramidis (Beyonttra). Health Canada updated its management of drug submissions and applications guidance, effective immediately. France’s Agence Nationale de Sécurité du Médicament (ANSM) said Euthyrox supplies are extended until the end of 2028, though not for new patients.