China’s National Medical Products Administration (NMPA) announced that potassium glucosamine sulfate has been reclassified from a prescription drug to over-the-counter (OTC) status. The move requires updates to product listings and OTC package insert templates.
Regulatory Update
Marketing Authorization Holders (MAHs) must submit revised package inserts to provincial medical products bureaus by April 6, 2023. The updated inserts will be distributed to medical institutions and drug operators. Content not specified in the OTC template must adhere to original approval documents. Drug labels must also be revised accordingly, and no new products can use the original inserts post-filing.
Market Impact
The change affects 18 manufacturers with active glucosamine approvals. The drug is widely used to treat osteoarthritis.-Fineline Info & Tech
