Regulatory Updates

Lawmakers aim to resolve standing committee deadlock in the 22nd National Assembly's plenary session on June 18, with health and welfare committee composition under focus.

Fierce Pharma’s H2 2026 Regulatory Tracker logs progress of existing products, noting geographic expansions and new indications, even when updates aren’t full stories.

The FDA has issued a recall for products with labeling errors, specifically incorrect or missing lot numbers and expiration dates that exceed the Beyond Use Date of at least one ingredient.

Pfizer complained about Alnylam’s promotional activities at a cardiology congress, prompting the PMCPA to criticize the biotech, but the UK marketing watchdog later reversed its harshest finding on appeal.

FDA recalls Next Advanced Antibacterial Hand Sanitizer due to ethanol below label claim and methanol contamination; related products from the same plant also withdrawn.

MHRA releases new safety and educational resources to support regulatory measures from the 2023 Patient Safety Alert and 2024 Drug Safety Update.

The MHRA’s annual MedSafetyWeek runs 3‑9 Nov 2025, focusing on the theme ‘we can all help make medicines safer’.

The Pharmaceuticals and Medical Devices Agency announces a symposium to mark the 10th anniversary of its Hokuriku Branch.

The Pharmaceuticals and Medical Devices Agency (PMDA) has posted its 2026 No.2 update, providing the latest regulatory information for stakeholders.

The Pharmaceuticals and Medical Devices Agency (PMDA) announced that applications are now open for the 2026 PMDA-ATC Blood Products Seminar for PPWG.

The Pharmaceuticals and Medical Devices Agency (PMDA) has updated its biosimilars information. Details are available on the PMDA website.

Medline Industries and Kimal PLC have reported safety concerns with Namic Angiographic Control Syringes and White Star Off‑Handle Manifold devices, issuing field safety notices to UK hospitals.