Regulatorische Updates

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.

The Committee on Veterinary Medicinal Products adopted a positive opinion on the marketing authorisation of Cirbloc, a vaccine for active immunisation of pigs.

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.

The EMA's Pharmacovigilance Risk Assessment Committee has started a review of injectable iron products concerning low blood phosphate levels and related bone problems.

The European Medicines Agency has started a voluntary data submission pilot to share data generated using New Approach Methodologies (NAMs).

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.

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.

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.

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.

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.