Update
On Sept. 11, 2023, China’s National Medical Products Administration (NMPA), Ministry of Public Security, and National Health Commission (NHC) adjusted the Catalogs of Anesthetics and Psychotropic Drugs. The changes are as follows:
1. Tegileridine has been included in the Catalog of Anesthetics.
2. Dimdazenil and etomidate (excluding pharmaceutical preparations containing etomidate that have been authorized for marketing in China) have been included in the Catalog of Category II Psychotropic Drugs.
3. Modafinil, previously categorized as a category I psychotropic drug, has been recategorized as a category II psychotropic drug.
The adjustments will take effect on Oct. 1, 2023.
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Previously
On July 5, 2023, China National Medical Products Administration (NMPA) and the General Administration of Customs (GACC) announced the customs codes for oliceridine, an anesthetic, as well as suvorexant, perampanel, eptazocine, and tramadol, four psychotropic drugs.
Customs Commodity Code | Commodity | |
Chinese Name | English Name | |
2934999094 | 奥赛利定 | Oliceridine |
3004909030 | 奥赛利定的单方制剂（已配定剂量或制成零售包装） | Preparation with a single agent of oliceridine (with measured doses or in retail packs) |
2934999094 | 苏沃雷生 | Suvorexant |
3004909049 | 苏沃雷生的单方制剂（已配定剂量或制成零售包装） | Preparation with a single agent of suvorexant (with measured doses or in retail packs) |
2933790051 | 吡仑帕奈 | Perampanel |
3004909049 | 吡仑帕奈的单方制剂（已配定剂量或制成零售包装） | Preparation with a single agent of perampanel (with measured doses or in retail packs) |
2933990096 | 依他佐辛 | Eptazocine |
3004909049 | 依他佐辛的单方制剂（已配定剂量或制成零售包装） | Preparation with a single agent of eptazocine (with measured doses or in retail packs) |
3004909042 | 曲马多复方制剂 | Tramadol combination preparation |
Notes: Oxelidine includes its possible salts, single-agent preparations, isomers, esters, and ether. Suvorexant, perampanel, eptazocine, and tramadol include their possible salts, single-agent preparations, and isomers. | ||
China has been reining in the supervision of these drugs. In April this year, NMPA adjusted the Catalogs of Anesthetics and Psychotropic Drugs, adding tramadol combination preparation, etazocine, and perampanel (including the latter two’s salts, isomers, and single agent preparations) to the Catalog of Category II Psychotropic Drugs.
Later in May, NMPA issued more requirements on these three drugs: manufacturers of tramadol, etazocine, and perampanel should apply for manufacturing qualification to be recognized by the local provincial medical products administration, and file the production plan for 2023. Companies that fail to obtain the qualification or file the plan will not be permitted to produce the three drugs. The new requirements have been effective since July 1, 2023.
