Regulations on Protection of Traditional Chinese Medicines

Regulations on Protection of Traditional Chinese Medicines

Order of State Council No.106

October 14, 1992

Regulations on Protection of Traditional Chinese Medicines

(Issued according to the Order of State Council No.106 on October 14, 1992)

CHAPTER I GENERAL PROVISIONS
　
Article 1 This decree is hereby formulated with the aims of raising the quality of all varieties of traditional Chinese medicines, of protecting the legal rights and interests of enterprises engaged in the production of traditional Chinese medicines, and of promoting the development of activities relating to traditional Chinese medicines.
　
Article 2 This Decree is applicable for all varieties of traditional Chinese medicines produced and/or prepared within the territory of China, including the traditional Chinese proprietary medicines, the extract and preparation of medicinal herbs, and the processed traditional Chinese herbs.
This Decree is not applicable for those varieties of traditional Chinese medicines applying for patent rights, which is subject to the law governing patent rights.
　
Article 3 The State practises graded protection for those varieties of traditional Chinese medicines stable in its quality and effective in its therapeutic results in order to encourage the research and development of new varieties of traditional Chinese medicines with clinical effectiveness.
　
Article 4 Health administrative departments under the State Council are responsible for the supervision and administration of activities relating to the protection of traditional Chinese medicines. The responsible departments at the state level in charge of the preparation and management of traditional Chinese medicines are to assist in the management of activities for the protection of all varieties of traditional Chinese medicines.

CHAPTER II THE GRADING AND APPROVAL OF PROTECTION OF VARIETIES OF TRADITIONAL CHINESE MEDICINES
　
Article 5 All varieties of traditional Chinese medicines covered by this Decree for protection shall be those listed as the standardized medicines at the state level. Application can be raised for those varieties listed, with the approval of health administrative departments under the State Council, as standardized medicines at the provincial/municipal/autonomous regional level.
All varieties covered by this Decree are divided into Grade 1 and Grade 2 in its protection.
　
Article 6 All varieties of traditional Chinese medicines conforming with 1 of the following requirements can apply for Grade 1 protection:
that
(1) are with special therapeutic results to a given disease;
(2) are prepared with natural medicinal herbs covered by Grade 1 protection by the state; and
(3) are applicable to the prevention and treatment of certain specific diseases.
　
Article 7 All varieties of traditional Chinese medicines conforming with 1 of the following requirements can apply for Grade 2 protection:
that
(1) are conforming with the stipulations set forth in Article 6, and are removed from Grade 1 protection;
(2) are with noticeable therapeutic results to a given disease; and
(3) are extracted, and/or specifically prepared with its effective ingredient from natural medicinal herbs.
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