This summary is compiled based on the latest regulatory requirements released by the General Administration of Customs of the People's Republic of China (GACC) and other competent authorities, focusing on the core policies, practical requirements and operational key points for the import of Chinese Medicinal Materials.

I. Core Policy Basis

1. GACC Announcement No.219 of 2025: *Requirements for the Declaration and Administration of Overseas Enterprises Engaged in Imported Agricultural Products*

2. Joint Announcement No.237 of 2025 by GACC, the National Health Commission, the State Administration for Market Regulation and the National Medical Products Administration: *Measures for the Pilot Implementation of Classified Administration of Imported Edible and Medicinal Substances*

II. Key Regulatory Requirements

1. Mandatory GACC Registration for Overseas Enterprises

All overseas manufacturing enterprises exporting Chinese Medicinal Materials to China must complete GACC in-china registration before export, as the products are included in the *Catalogue of Imported Agricultural Products Requiring Official Recommendation for Registration and Filing*.

· Validity period of registration number: The registration number for plant-derived Chinese Medicinal Materials is permanently valid (until December 31, 2999); that for animal-derived Chinese Medicinal Materials is generally valid for 5 years (with individual exceptions, e.g., 4 years for Argentine bezoar).

2. Pilot Classified Administration of Edible and Medicinal Substances

A list of 30 pilot edible and Medicinal substances (e.g., clove, Chinese angelica, American ginseng, Dendrobium officinale) has been released, and enterprises may independently declare the intended use of such substances:

· For medicinal use: The *Customs Clearance Form for Imported Drugs* must be submitted to the customs in accordance with pharmaceutical supervision regulations.

· For other uses: Exemption from submitting the above-mentioned clearance form (governed by food import and export regulations), but the use must be declared truthfully and shall not be altered without authorization for sale.

3. Qualifications and Import Procedures for Domestic Importers

(1) Eligible domestic importers

· Marketing authorization holders of proprietary Chinese Medicinal Materials (with copy of relevant drug approval documents)

· Chinese Medicinal Materials manufacturers (holding the Drug Manufacturing License)

· Pharmaceutical trading enterprises (holding the Drug Trading License with business scope covering Chinese Medicinal Materials or prepared slices of Chinese Medicinal Materials)

(2) Import filing procedures

· First-time import: Subject to approval by the provincial drug regulatory authority in advance; the *Approval Document for Imported Medicinal Materials* obtained must be used for import within 1 year (otherwise the document shall become invalid).

· Non-first-time import: Filing can be completed directly at the port drug regulatory authority with simplified procedures. A *Catalogue of Non-First-Time Imported Medicinal Material Varieties* has been issued, including 93 varieties (with clear defined original plant/animal sources and producing areas).

III. Designated Import Ports

1. Pharmaceutical import ports (more than 30)

Including all ports under the jurisdiction of 19 cities (Beijing, Tianjin, Shanghai, Qingdao, Chengdu, etc.) and 11 special designated ports (Suzhou Industrial Park Port, Jinan Aviation Port, Changsha Aviation Port, etc.), all approved by the State Council for drug import.

2. Border ports for Medicinal material import (23)

Distributed in border provinces and autonomous regions of China, including:

· Heilongjiang: Heihe, Dongning, Suifenhe, Tongjiang

· Jilin: Ji'an, Changbai, Tumen, etc.

· Inner Mongolia: Erenhot, Manzhouli

· Guangxi: Aidian, Pingxiang, Dongxing, etc.

· Yunnan: Ruili, Tianbao, Jinghong, Mohan (including Mohan Railway Port), etc.

· Xinjiang: Alashankou, Khorgos, Turugart, etc.

· Xizang: Zhangmu, Gyirong, Pulan

IV. Attached Key Catalogues

1. List of 30 Pilot Edible and Medicinal Substances for Import Classified Administration (governed by corresponding national food safety standards or official announcements)

2. *Catalogue of Non-First-Time Imported Medicinal Material Varieties* (93 varieties, including catechu, saffron, agarwood, seahorse, etc., with detailed original sources and producing areas specified)

Note: The above information is based on the latest official releases of competent authorities; for specific implementation, please refer to the updated announcements on the official websites of GACC, the National Medical Products Administration and other departments.