Ministry of Health, National Development and Reform Commission, Ministry of Industry and Information Technology, Ministry of Supervision, Ministry of Finance, Ministry of Human Resources and Social Security, Ministry of Commerce, State Food and Drug Administration, State Administration of Traditional Chinese Medicine, Measures for the Administration of State Essential Pharmaceuticals Lists (Tentative)

卫生部、国家发展和改革委员会、工业和信息化部、监察部、财政部、人力资源和社会保障部、商务部、国家食品药品监督管理局、国家中医药管理局国家基本药物目录管理办法 (暂行)

October 10, 2009 | BY

clpstaff &clp articles &

Safety and pricing emphasised in essential medicine lists.

Clp Reference: 1740/09.08.18 Promulgated: 2009-08-18 Effective: 2009-08-18

Issued: August 18 2009

Effective: as of date of issuance

Interpreting authority: Ministry of Health

Main contents: The pharmaceuticals specified in State Essential Pharmaceuticals Lists (Lists) include chemical pharmaceuticals, biological products and prepared traditional Chinese medicines (Article 2). The selection of state essential pharmaceuticals shall follow the principles of necessity, safety and effectiveness, reasonable pricing, convenience for use, equal importance of Chinese and western medicines, basic protection, first choice for clinical treatment and being affordable to the grass roots. The type (dosage form) and quantity of pharmaceuticals shall be determined in conjunction with the characteristics of pharmaceutical use in China and by drawing upon international experience (Article 4).

Except for pharmaceuticals that are used for first aid and emergency, all products solely manufactured by one company shall undergo separate discussion before they are included in the Lists (Article 5). The following pharmaceuticals shall not fall under the scope of selection for the Catalogue:

(1) medicinal materials that contain state endangered wild flora and fauna resources;

(2) pharmaceuticals that are used mainly for nourishment and health and are prone to abuse;

(3) pharmaceuticals that are not the first choice for clinical treatment;

(4) pharmaceuticals whose production, sale and use are clearly stipulated by the state food and drug regulatory department to be suspended due to the strong adverse reactions they cause; and

(5) pharmaceuticals that violate state laws or regulations or that fail to satisfy ethics requirements (Article 6).

Related legislation: Opinion on Intensifying the Reform of the Pharmaceutical and Health System, Mar 17 2009; and Circular on the Issuance of Recent Major Implementing Plans for the Reform of the Pharmaceutical and Health System (2009 - 2011), Mar 18 2009

clp reference:1740/09.08.18(2)promulgated:2009-08-18effective:2009-08-18

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