Regulations on Protection of Traditional Chinese Medicines (2018 Revision)

Regulations on Protection of Traditional Chinese Medicines (2018 Revision) REGULATIONS ON PROTECTION OF TRADITIONAL CHINESE MEDICINES (Promulgated by Decree No. 106 of the State Council of the People's Republic of China on October 14, 1992; and amended in accordance with the Order No. 703 of State Council, the Decision of the State Council to Amend Certain Administrative Regulations on September 18, 2018) 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 The drug supervision and administration department of the State Council shall be responsible for the supervision and administration of the protection of varieties of traditional Chinese medicines (“TCM”) nationwide. 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 drug supervision and administration department of 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. Article 8 Any new variety of traditional Chinese medicines having been duly approved by drug supervision and administration department of the State Council are subject to protection for a period as specified by the drug supervision and administration department of the State Council, of which, if having been found conforming with the stipulations as set forth in Article 6 and/or Article 7, can apply, following the procedures as set forth in this Decree, for protection 6 months prior to the termination of the period for protection as approved specifically by drug supervision and administration department of the State Council. Article 9 Procedures for filing an application for the protection of any TCM variety: (1) A TCM manufacturer may apply for the protection of any TCM variety that meets the provisions of Articles 5, 6, 7 and 8 of this Regulation to the drug supervision and administration department of the people's gover......