Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a set of principles for the responsible use of artificial intelligence in regulatory activities. The document outlines a human-centred approach, risk-based governance, data management, oversight and ongoing evaluation of AI systems used in regulatory decision-making. Scope of the principles The document, Basic Principles for the Use of AI in Regulatory Activities (Early Consideration), was issued by PMDA’s Center for Regulatory Science on...

Kazakhstan has been approved for an on-site assessment mission and an observed inspection in 2027 as part of its application for membership of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The decision was made at a PIC/S meeting in Istanbul on 2–3 November 2026, attended by inspectors from the National Centre for Expertise of Medicines and Medical Devices under the Ministry of Healthcare of Kazakhstan. The on-site mission will be the...

China’s National Medical Products Administration (NMPA) put its revised Good Manufacturing Practice (GMP) for Medical Devices into effect on 1 November 2026. Issued under NMPA Announcement No. 107, the revised regulation replaces the 2014 edition and introduces more comprehensive requirements for quality assurance, lifecycle risk management, validation and verification, and contract manufacturing. The updated framework applies to medical device registrants, filing holders and contract manufacturers. It covers design and development,...

The US Food and Drug Administration (FDA) has proposed a regulatory framework for individualized human genome editing therapies, while the Centers for Medicare & Medicaid Services (CMS) plans to expand its Cell and Gene Therapy (CGT) Access Model beyond sickle cell disease. Together, these separate initiatives aim to support the development of therapies for rare genetic diseases and improve patient access to cell and gene therapies through Medicaid. Announced by...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 recall covering all strengths and all batches of Xeal Pharma’s clopidogrel oral solutions and suspensions manufactured before the recall notification. A formulation error resulted in the affected products containing 76% of the required amount of active ingredient. The case highlights three critical quality challenges: control of active substance content in liquid dosage forms, investigation of...