3 March 2016
Enquiry: What are China’s New Supervisory Measures for the Import of Traditional Chinese Medicines?
According to the Measures for the Supervision and Administration of Entry-Exit Quarantine of Traditional Chinese Medicines which came into effect on 1 December 2015, the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) is in full charge of the supervision, inspection and quarantine of traditional Chinese medicines entering and exiting the country, while its entry-exit inspection and quarantine departments (CIQ) set up in different localities are responsible for the supervision, inspection and quarantine of traditional Chinese medicines entering and exiting the regions under their respective jurisdiction.
AQSIQ implements an entry-exit declaration of use system for traditional Chinese medicines. When traditional Chinese medicines enter or exit the country, the responsible enterprise should declare their expected use to the local CIQ stating whether they are “for medical use” or “for human consumption”.
Traditional Chinese medicines declared “for medical use” should be items listed under the medicinal materials catalogue in the Pharmacopoeia of the People's Republic of China; while those declared “for human consumption” should be edible items provided in national laws, administrative rules, regulations, and documents.
AQSIQ implements entry-exit risk management for traditional Chinese medicines. Offshore production, processing and storage entities (called offshore production enterprises) of traditional Chinese medicines for import into China must go through registration, with a validity period of four years. Production, processing and storage entities (called export production enterprises) of traditional Chinese medicines for export must also go through registration in accordance with the requirements of the importing country or region. Enterprises producing and handling the import and export of traditional Chinese medicines are subject to integrity management.
For countries and regions exporting traditional Chinese medicines to China for the first time, AQSIQ would analyse product risk and assess their supervision system. As for countries and regions which already have trade relations with China, a review would be conducted. AQSIQ will, based on the risk analysis and assessment or review findings, consult with the supervisory department of the exporting country or region to determine the quarantine requirements regarding the traditional Chinese medicines imported into China, sign an agreement concerned, and endorse the quarantine certificate. AQSIQ is responsible for compiling, revising and announcing online the list of countries and regions allowed to export traditional Chinese medicines to China and their product categories.
AQSIQ will, based on the findings of risk analysis, ascertain and implement the catalogue of traditional Chinese medicines registered by offshore production, processing and storage entities, and will make dynamic adjustments. AQSIQ will also formulate and announce registration and assessment procedures as well as technical requirements separately.