Background
On May 7, 2024, several Chinese government agencies—the National Medical Products Administration (NMPA), Ministry of Public Security (MPS), and National Health Commission (NHC) —announced changes to the classification of certain ingredients and drugs under China's psychotropic drugs catalog:
Dextromethorphan (including salts and single-ingredient preparations), nalfurafine (including salts, isomers and single-ingredient preparations), lorcaserin (including salts, isomers and single-ingredient preparations), and compound diphenoxylate preparations will be moved to Category II Psychotropic Drugs.
Midazolam active pharmaceutical ingredients (including salts and isomers) and injections will be reclassified from Category II to Category I Psychotropic Drugs.
These regulatory changes are scheduled to take effect on July 1, 2024.
On May 21, 2024, China NMPA and NHC further clarified that starting July 1, 2024, the research, procurement, mailing, transportation, import and export of the affected ingredients and drugs must be subject to the Drug Administration Law and Regulations on the Administration of Narcotic Drugs and Psychotropic Substances. Medical institutions must also comply with the requirements corresponding to the new categories when purchasing, storing and using them.
Additionally, the NMPA and NHC specified enforcement rules concerning the manufacture, labeling, supply and traceability of the affected ingredients and preparations.
Manufacture
Pharmaceutical companies producing dextromethorphan, midazolam active pharmaceutical ingredients and injections, as well as compound diphenoxylate preparations shall apply for the designated manufacture qualification from the local provincial MPAs.
Pharmaceutical companies producing dextromethorphan and midazolam injections shall notify their manufacturing plan for 2024.
From July 1, 2024, enterprises that have not obtained designated manufacture qualification or approval of manufacture plan shall not produce the affected ingredients and drugs. The affected ingredients and drugs shall not be entrusted for production.
Labeling
The MAHs and manufacturers of dextromethorphan, nalfurafine, and compound diphenoxylate preparations shall strictly follow the Provisions for Drug Registration to handle the procedures for changing the labels and instructions for use.
From October 1, 2024, all such drugs produced and imported must display the required markings on their labels and instructions for use. Any of the aforementioned drugs that were produced and imported prior to that date can continue to be circulated and used within their respective validity periods.
Supply
From May 21, 2024, drug suppliers that do not possess the qualification for Category II Psychotropic Drugs shall be prohibited from purchasing dextromethorphan, nalfurafine, and compound diphenoxylate preparations. They can sell the existing inventory of these products until sold out, after informing the local MPAs. In addition, drug enterprises lacking the qualification for Category I Psychotropic Drugs shall be barred from purchasing midazolam injections. Any of these products currently held in inventory must be returned through the original distribution channels.
Traceability
The MAHs, drug manufacturers and suppliers of dextromethorphan, nalfurafine, and compound diphenoxylate preparations shall establish and implement the corresponding traceability system and provide traceability information in accordance with the Drug Administration Law.
Medical institutions shall also provide drug traceability information for these drugs.
