The National Medical Products Administration (NMPA) announced that omeprazole enteric-coated tablets have been reclassified from prescription-only to over-the-counter (OTC) status in China. The 10mg dosage is approved for short-term relief of heartburn and acid reflux symptoms caused by hyperacidity.
Regulatory Update
Marketing Authorization Holders (MAHs) are required to submit revised package inserts to provincial medical product administrations by May 24, 2023. Companies must also notify medical institutions and drug operators of the changes.
Market Context
Fineline Info & Tech data indicates 19 companies hold valid registrations for omeprazole enteric-coated tablets in China, including AstraZeneca. The OTC switch aims to improve accessibility for patients with acid-related disorders.-Fineline Info & Tech
