Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Aug 23, 2026•1 min read
PMDA Updates Information on Biosimilars
The Pharmaceuticals and Medical Devices Agency (PMDA) has updated its biosimilars information. Details are available on the PMDA website.
Regulatory Updates
Aug 23, 2026•1 min read
PMDA Publishes List of Approved Regenerative Medical Products (Apr 2015–May 2026)
The Japanese Pharmaceuticals and Medical Devices Agency has released an updated list of regenerative medical products approved between April 2015 and May 2026.
Regulatory Updates
Aug 23, 2026•1 min read
PMDA Releases English Translation of Review Report for Optune Lua and Esprit BTK Scaffold System
The Japanese PMDA has published an English translation of its review report for the Optune Lua and Esprit BTK Everolimus eluting resorbable scaffold system.
Regulatory Updates
Aug 23, 2026•1 min read
PMDA Publishes English Review Report for Beovu Partial Change Approval
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.
Regulatory Updates
Aug 23, 2026•1 min read
PMDA Revises Precautions for Donanemab and Other Drugs
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted updated precautionary information for Donanemab and other medicines.
Regulatory Updates
Aug 23, 2026•1 min read
Crescent Pharma Recalls Ramipril 10mg Capsules Batch
Crescent Pharma Limited is recalling a batch of Ramipril 10mg capsules as a precaution due to a possible manufacturing error.
Regulatory Updates
Aug 23, 2026•1 min read
Doncaster Pharma alerts MHRA over Braille embossing error on Hiprex 1 g tablets
Doncaster Pharma reported a Braille embossing error on the outer packaging of certain parallel‑imported Hiprex 1 g tablets to the MHRA.
Regulatory Updates
Aug 23, 2026•1 min read
MHRA Publishes Field Safety Notices for 13‑17 April 2026
The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices issued between 13 and 17 April 2026.
Regulatory Updates
Aug 23, 2026•1 min read
Omega Pharma Recalls Napralief 250mg Tablets Over Missing PIL Text
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.
Regulatory Updates
Aug 23, 2026•1 min read
Amarox Limited recalls Sertraline 100 mg tablets batch over manufacturing error
Amarox Limited is recalling a batch of 100 mg film‑coated sertraline tablets due to a manufacturing site error.
Regulatory Updates
Aug 23, 2026•1 min read
MHRA Issues April 2026 Safety Advice for Medicines and Devices
The UK MHRA released its April 2026 safety roundup, summarising the latest advice for medicine and medical device users.
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Regulatory Updates
Aug 23, 2026•1 min read
MHRA Publishes Field Safety Notices for 20‑24 April 2026
The UK Medicines and Healthcare products Regulatory Agency (MHRA) released a list of Field Safety Notices covering 20‑24 April 2026.