The National Medical Products Administration (NMPA) and National Health Commission (NHC) have released a notification regarding the regulation of tramadol compound preparations and other substances. Effective from July 1, 2023, manufacturers without designated qualifications and production demand plans are prohibited from manufacturing tramadol compound preparations, eptazocine, or perampanel. Additionally, an import/export license is now mandatory for the import and export of these products.
Compliance with Drug Administration Law and Tracking Systems
Marketing Authorization Holders (MAHs), drug manufacturers, operators, and medical institutions are required to comply with the Drug Administration Law concerning psychotropic drugs. They must establish and implement tracking systems to ensure proper control and monitoring of these substances.
Esketamine’s Classification as a Class 1 Psychotropic Drug
Esketamine, which was recently approved for marketing in China, is now regulated as a Class 1 psychotropic drug. This classification reflects its potential impact on public health and the need for stringent control measures.
Joint Notification on Narcotics and Psychotropic Substances Catalogue Adjustment
In a joint notification with the Ministry of Public Security, NMPA and NHC have listed tramadol, eptazocine, and perampanel as Class 2 psychotropic drugs, effective from July 1, 2023. This adjustment aims to strengthen the control and management of these substances, aligning with international standards and domestic regulations.-Fineline Info & Tech
