The National Medical Products Administration (NMPA) and the National Health Commission (NHC) of China have issued a notification to enhance the management and control of certain substances, effective from July 1, 2024. Dextromethorphan, lorcaserin, and diphenoxylate will be reclassified under the Category II psychotropic drug list, while midazolam will be transferred from Category II to Category I for stricter administration.
The regulatory update implies that manufacturers without the requisite qualifications or approved production and usage plans will be prohibited from producing these drugs. Additionally, specific identification marks must be printed on the labels and package inserts of dextromethorphan, nalfurafine, and diphenoxylate products that are manufactured or imported. These products can continue to be distributed and used until their expiration dates, provided they were produced or imported before the regulation’s effective date. Furthermore, operators who do not meet the new criteria are barred from purchasing these substances from the date of the notice.- Flcube.com
