REGULATIONS ON PROTECTION OF TRADITIONAL CHINESE MEDICINES | | 中药品种保护条例 |
(Promulgated by Decree No. 106 of the State Council of the People's Republic of China on October 14, 1992; and revised in accordance with the Decision of the State Council to Amend Certain Administrative Regulations on September 18, 2018) | | (1992年10月14日中华人民共和国国务院令第106号发布 根据2018年9月18日《国务院关于修改部分行政法规的决定》修订) |
CHAPTER I GENERAL PROVISIONS | | 第一章 总则 |
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. | | 第一条 为了提高中药品种的质量,保护中药生产企业的合法权益,促进中药事业的发展,制定本条例。 |
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. | | 第二条 本条例适用于中国境内生产制造的中药品种,包括中成药、天然药物的提取物及其制剂和中药人工制成品。 |
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. | | 申请专利的中药品种,依照专利法的规定办理,不适用本条例。 |
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. | | 第三条 国家鼓励研制开发临床有效的中药品种,对质量稳定、疗效确切的中药品种实行分级保护制度。 |
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. | | 第四条 国务院药品监督管理部门负责全国中药品种保护的监督管理工作。 |
CHAPTER II THE GRADING AND APPROVAL OF PROTECTION OF VARIETIES OF TRADITIONAL CHINESE MEDICINES | | 第二章 中药保护品种等级的划分和审批 |
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. | | 第五条 依照本条例受保护的中药品种,必须是列入国家药品标准的品种。经国务院药品监督管理部门认定,列为省、自治区、直辖市药品标准的品种,也可以申请保护。 |
All varieties covered by this Decree are divided into Grade 1 and Grade 2 in its protection. | | 受保护的中药品种分为一、二级。 |
Article 6 All varieties of traditional Chinese medicines conforming with 1 of the following requirements can apply for Grade 1 protection:that | | 第六条 符合下列条件之一的中药品种,可以申请一级保护: |
(1) are with special therapeutic results to a given disease; | | (一)对特定疾病有特殊疗效的; |
(2) are prepared with natural medicinal herbs covered by Grade 1 protection by the state; and | | (二)相当于国家一级保护野生药材物种的人工制成品; |
(3) are applicable to the prevention and treatment of certain specific diseases. | | (三)用于预防和治疗特殊疾病的。 |
Article 7 All varieties of traditional Chinese medicines conforming with 1 of the following requirements can apply for Grade 2 protection:that | | 第七条 符合下列条件之一的中药品种,可以申请二级保护: |
(1) are conforming with the stipulations set forth in Article 6, and are removed from Grade 1 protection; | | (一)符合本条例第六条规定的品种或者已经解除一级保护的品种; |
(2) are with noticeable therapeutic results to a given disease; and | | (二)对特定疾病有显著疗效的; |
(3) are extracted, and/or specifically prepared with its effective ingredient from natural medicinal herbs. | | (三)从天然药物中提取的有效物质及特殊制剂。 |
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. | | 第八条 国务院药品监督管理部门批准的新药,按照国务院药品监督管理部门规定的保护期给予保护;其中,符合本条例第六条、第七条规定的,在国务院药品监督管理部门批准的保护期限届满前六个月,可以重新依照本条例的规定申请保护。 |
Article 9 Procedures for filing an application for the protection of any TCM variety: | | 第九条 申请办理中药品种保护的程序: |
(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 government of the province, autonomous region, or municipality directly under the Central Government where it is located, and the latter shall, after conducting preliminary examination and provide its opinions, submit the application to the drug supervision and administration department of the State Council. Under any special circumstance, a TCM manufacturer may also directly file an application with the drug supervision and administration department of the State Council. ...... | | (一)中药生产企业对其生产的符合本条例第五条、第六条、第七条、第八条规定的中药品种,可以向所在地省、自治区、直辖市人民政府药品监督管理部门提出申请,由省、自治区、直辖市人民政府药品监督管理部门初审签署意见后,报国务院药品监督管理部门。特殊情况下,中药生产企业也可以直接向国务院药品监督管理部门提出申请。 ...... |
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