Regulatory Updates
Sep 22, 2026•2 min read
EMA CHMP recommends 12 new medicines and multiple extensions in September 2026 meeting
The EMA Committee on Medicinal Products for Human Use (CHMP) recommended 12 new medicines for approval and issued several biosimilar, generic, re‑examination and indication‑extension updates.
Regulatory Updates
Sep 12, 2026•1 min read
EMA CVMP Gives Positive Opinion on Cirbloc for Pig Immunisation
The Committee on Veterinary Medicinal Products adopted a positive opinion on the marketing authorisation of Cirbloc, a vaccine for active immunisation of pigs.
Regulatory Updates
Sep 9, 2026•1 min read
MFDS adds domperidone contraindication for chromaffin‑cell tumor patients across 38 products
South Korea’s MFDS will revise labeling of 38 domperidone products to contraindicate use in patients with chromaffin‑cell tumors due to risk of severe hypertension.
Regulatory Updates
Sep 6, 2026•1 min read
EMA PRAC launches review of injectable iron medicines over hypophosphatemia risk
The EMA's Pharmacovigilance Risk Assessment Committee has started a review of injectable iron products concerning low blood phosphate levels and related bone problems.
Regulatory Updates
Sep 1, 2026•1 min read
EMA launches voluntary data submission pilot for New Approach Methodologies
The European Medicines Agency has started a voluntary data submission pilot to share data generated using New Approach Methodologies (NAMs).
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Regulatory Updates
Aug 30, 2026•1 min read
MFDS to Amend Approval Conditions for Mycophenolate and Albendazole Products Based on FDA and EMA Safety Reviews
Korea’s MFDS is drafting a change order for mycophenolate and albendazole drug labels, incorporating safety findings from the US FDA and EU EMA, and has opened a public comment period.
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Regulatory Updates
Aug 30, 2026•1 min read
KRPIA Welcomes Korea’s First International Joint Drug Review via EMA’s OPEN Program
The Korea Research-based Pharmaceutical Industry Association (KRPIA) praised the MFDS for completing its first joint drug assessment with overseas regulators through EMA’s OPEN program, conducted simultaneously in Europe and Korea.
Regulatory Updates
Aug 30, 2026•1 min read
KRPIA Welcomes First Joint Drug Review via EMA's OPEN Program
KRPIA praised MFDS for completing the first joint pharmaceutical review with overseas regulators through EMA's OPEN program, marking a milestone in Korea‑EU collaboration.
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Regulatory Updates
Aug 25, 2026•2 min read
EMA CHMP July 2026 Meeting Recommends 12 New Medicines and Multiple Extensions
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended twelve new medicines for approval and issued several positive, negative and withdrawal decisions on other products.
Regulatory Updates
Aug 25, 2026•1 min read
EMA Announces New Leadership Team Appointments
The European Medicines Agency has appointed a new Head of Stakeholders and a new Head of Veterinary, highlighting Ivo Claassen’s role since 2018 in the veterinary medicines network.