Regulatorische Updates

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

The Japanese Pharmaceuticals and Medical Devices Agency has released an updated list of regenerative medical products approved between April 2015 and May 2026.

The Japanese PMDA has published an English translation of its review report for the Optune Lua and Esprit BTK Everolimus eluting resorbable scaffold system.

The Pharmaceuticals and Medical Devices Agency (PMDA) has released an English translation of its review report concerning the partial change approval of the ophthalmic drug Beovu.

The Pharmaceuticals and Medical Devices Agency (PMDA) has posted updated precautionary information for Donanemab and other medicines.

Crescent Pharma Limited is recalling a batch of Ramipril 10mg capsules as a precaution due to a possible manufacturing error.

Doncaster Pharma reported a Braille embossing error on the outer packaging of certain parallel‑imported Hiprex 1 g tablets to the MHRA.

The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices issued between 13 and 17 April 2026.

Omega Pharma Ltd is recalling specific batches of Napralief 250mg gastro‑resistant tablets because sections of the patient information leaflet and carton labeling are missing.

Amarox Limited is recalling a batch of 100 mg film‑coated sertraline tablets due to a manufacturing site error.

The UK MHRA released its April 2026 safety roundup, summarising the latest advice for medicine and medical device users.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) released a list of Field Safety Notices covering 20‑24 April 2026.