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 effective as of January 1,1993）
Chapter I General Provisions
Article 1 These Regulations are formulated for the purposes of improving the quality of types of traditional Chinese medicine, protecting the legitimate rights and interests of traditional Chinese medicine producing enterprises, and promoting the development of traditional Chinese medicine.
Article 2 These Regulations apply to types of traditional Chinese medicine produced and manufactured within the territory of China, including prepared traditional Chinese medicines, extracts and preparations from natural medicinal materials, as well as artificial traditional Chinese medicines.
Those types of traditional Chinese medicine for which patents are applied for shall be dealt with under the provisions of the Patent Law, and not under these Regulations.
Article 3 The State encourages research and development of types of traditional Chinese medicine with clinical effects, and practices a classification protection system for types of traditional Chinese medicine with reliable quality and certain curative effects.
Article 4 The administrative department of public health under the State Council shall be responsible for the supervision and control of the protection of types of traditional Chinese medicine throughout the country. The State competent authority for the production and trading of traditional Chinese medicine shall assist the administrative department with the control of the protection of types of traditional Chinese medicine throughout the country.
Chapter II Classification and Approval for the Protection of Types of Traditional Chinese Medicine
Article 5 Types of traditional Chinese medicine under the protection of these Regulations must be those listed in the national pharmaceutical standards. Upon the determination of the administrative department of public health under the State Council, protection of types of traditional Chinese medicine listed in the pharmaceutical standards of provinces, autonomous regions and municipalities directly under the Central Government may be applied for.
The protection of types of traditional Chinese medicine shall consist of first class protection and second class protection.
Article 6 For types of traditional Chinese medicine which conform to any of the following conditions, first class protection may be applied for.
（1） having special curative effects for a certain disease；
（2） artificial medicines prepared from varieties of wild medicinal materials analogously under first class protection； or
（3） used for the prevention and cure of special diseases.
Article 7 For types of traditional Chinese medicine which conform to any of the following conditions, second class protection may be applied for.
（1） conforming to the provisions of Article 6 in these Regulations, or having once been listed under first class protection but now being cancelled；
（2） having outstanding curative effects for a certain disease； or
（3） effective substances and special preparations extracted from natural medicinal materials.
Article 8 New medicines approved by the administrative department of public health under the State Council shall be protected within a period of protection as described by the administrative department. For those of them which conform to the provisions of Article 6 or 7 in these Regulations, an application for the renewal of the protection may, six months before the expiration date of protection approved by the administrative department of public health under the State Council, be offered according to the provisions of these Regulations.
Article 9 Procedures for handling applications for the protection of types of traditional Chinese medicine are as follows：
（1） Any traditional Chinese medicine producing enterprise may, if it thinks that the type of traditional Chinese medicine it produces conforms to the provisions of Article 5, 6, 7 or 8 in these Regulations, apply for protection with the local competent authority for the production and trading of traditional Chinese medicine in the province, autonomous region or municipality directly under the Central Government. The local competent authority for the production and trading of traditional Chinese medicine shall write down its comments on the application, then transmit it to the administrative department of public health at the same level, which shall make a preliminary examination and write down its comments and submit the application, with comments, to the administrative department of public health under the State Council. Under special circumstances, a traditional Chinese medicine producing enterprise may directly apply to the State competent authority for the production and trading of traditional Chinese medicine which shall write down comments on the application and transmit it to the administrative department of public health under the State Council, or may directly apply to the administrative department of public health under the State Council.
（2） The State examination and evaluation committee for the protection of types of traditional Chinese medicine shall, under the authorization of the administrative department of public health under the State Council, be responsible for the examination and evaluation of the types of traditional Chinese medicine for which the protection is applied for. The committee shall provide an examination and evaluation conclusion within six months as of the date of receiving an application.
（3） Based on the conclusion of the State examination and evaluation committee for the protection of types of traditional Chinese medicine, the administrative department of public health under the State Council shall, in consultation with the State competent authority for the production and trading of traditional Chinese medicine, decide whether or not to grant the protection thereto. For the types of traditional Chinese medicine of which the protection has been approved, the administrative department of public health under the State Council shall issue a Certificate of Protection of Types of Traditional Chinese Medicine.
The administrative department of public health under the State Council shall be responsible for the formation of the State examination and evaluation committee for the protection of types of traditional Chinese medicine, members of which shall, in consultation with the State competent authority for the production and trading of traditional Chinese medicine, be appointed from experts in the field of medical service, scientific research, inspection, as well as trading and management of traditional Chinese medicine.
Article 10 Any enterprise applying for protection of types of traditional Chinese medicine shall provide the State examination and evaluation committee for the protection of types of traditional Chinese medicine with complete sets of materials as required by the administrative department of public health under the State Council.
Article 11 The administrative department of public health under the State Council shall make announcements in the designated professional newspapers and periodicals regarding the types of traditional Chinese medicine to which protection has been granted or those for which the period of protection has expired.
Chapter III Protection of Protected Types of Traditional Chinese Medicine
Article 12 The period of protection for types of traditional Chinese medicine is as follows：
The period of first class protection is thirty years, twenty years and ten years respectively.
The period of second class protection is seven years.
Article 13 Within the period of protection, the prescriptions and pharmaceutical techniques of types of traditional Chinese medicine under first class protection shall be kept secret and shall not be published by the producing enterprises having been granted the Certificate of Protection of Types of Traditional Chinese Medicine, the competent authorities for the production and trading of traditional Chinese medicine, the administrative departments of public health, and other units or individuals concerned.
Departments, enterprises and units concerned which have the duty to keep secrets shall set up necessary security systems as required by the State.
Article 14 Transfer to any foreign country of prescriptions and pharmaceutical techniques of types of traditional Chinese medicine under first class protection shall be dealt with according to the relevant State provisions of security.
Article 15 Where, due to special circumstances, it is necessary to extend the period of protection of a type of traditional Chinese medicine under first class protection, the producing enterprise shall, six months before the expiration date of protection, submit an application for extension according to the procedures described in the Article 9 of these Regulations. The extended period of protection shall be decided by the State examination and evaluation for the protection of types of traditional Chinese medicine, however, an extension approved each time shall not exceed the period of protection granted for the first time.
Article 16 The period of protection of types of traditional Chinese medicine under second protection may be extended for seven years upon expiration.
If it is necessary to extend the period of protection of a type of traditional Chinese medicine under second class protection, the producing enterprise shall, six months before the expiration date of protection, submit an application for extension according to the procedures described in the Article 9 of these Regulations.
Article 17 The production of protected types of traditional Chinese medicine within the period of protection shall be restricted to enterprises which have been granted the Certificate of Protection of Types of Traditional Chinese Medicine, unless otherwise provided for in Article 19 of these Regulations.
Article 18 Where more than one enterprises produce a type of traditional Chinese medicine under protection before the protection is granted by the administrative department of public health under the State Council, those enterprises who have not applied for the Certificate of Protection of Types of Traditional Chinese Medicine shall, within six months as of the date of announcement, report the case to the administrative department of public health under the State Council and provide relevant materials according to the provisions of Article 10 of these Regulations. The administrative department of public health under the State Council shall designate a pharmaceutical inspection institution to inspect the quality of the reported type of medicine as has been done with the type under protection. Based on the inspection, the administrative department of public health under the State Council may take the following measures：
（1） If it is up to the national pharmaceutical standards, the Certificate of Protection of Types of Traditional Chinese Medicine shall be issued through consultation with the State competent authority for the production and trading of traditional Chinese medicine.
（2） If it is below the national pharmaceutical standards, the registered document of approval of this type of traditional Chinese medicine shall be revoked according to the laws and regulations governing pharmaceutical administration.
Article 19 For protected types of traditional Chinese medicine in short supply for clinical needs, the administrative departments of public health in provinces, autonomous regions and municipalities directly under the Central Government shall, as proposed by the State competent authority for the production and trading of traditional Chinese medicine, and with the approval of the administrative department of public health under the State Council, issue registered documents of approval to the enterprises which produce in their localities the same types of traditional Chinese medicine as the protected types for imitation. The imitation enterprises shall pay reasonable use fees to the enterprises who hold the Certificate of Protection of Types of Traditional Chinese Medicine and transfer the prescriptions and pharmaceutical techniques of the protected types. The amounts of the use fees shall be decided by the two sides through consultation. If the two sides fail to reach an agreement, the administrative department of public health under the State Council shall make a ruling.
Article 20 Enterprises producing protected types of traditional Chinese medicine and the competent authorities for the production and trading of traditional Chinese medicine shall improve conditions of production and the qualities of the protected types as required by the administrative departments of public health in provinces, autonomous regions and municipalities directly under the Central Government.
Article 21 Registration of protected types of traditional Chinese medicine within the period of protection in any foreign country shall be subject to the approval of the administrative department of public health under the State Council.
Chapter IV Penalties
Article 22 If anyone divulges secrets in violation of the provisions of Article 13 of these Regulations, the unit to which he belongs or the higher authority shall impose upon him disciplinary sanctions. If a crime has been constituted, criminal liability shall be investigated according to laws.
Article 23 If anyone, in violation of the provisions of Article 17 of these Regulations, imitates a protected type of traditional Chinese medicine without approval, the administrative departments of public health at or above the county level shall punish him as a producer of fake medicines.
If anyone fabricates the Certificate of Protection of Types of Traditional Chinese Medicine and relevant certification documents to produce and sell medicines, the administrative departments of public health at or above the county level shall confiscate all medicines involved and illegal gains, and may concurrently fine him not more than three times the prices of the standard equivalents of medicines involved.
If the aforesaid acts have constituted crimes, the judicial organs shall investigate for criminal liabilities.
Article 24 A party who refuses to accept the decision of punishment made by the administrative departments of public health may apply for administrative reconsideration or institute administrative proceedings according to the relevant provisions of laws and administrative regulations.
Chapter V Supplementary Provisions
Article 25 Requirements and application forms for the protection of types of traditional Chinese medicine shall be decided by the administrative department of public health under the State Council.
Article 26 The administrative department of public health under the State Council shall be responsible for the interpretation of these Regulations.
Article 27 These Regulations shall come into effect on January 1, 1993.
中华人民共和国国务院令
（第106号）
（1992年10月14日中华人民共和国国务院令第106号发布，1993年1月1日起施行。）
中药品种保护条例
第一章 总 则
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。
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。
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。
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。
第四条 国务院卫生行政部门负责全国中药品种保护的监督管理工作。国家中药生产经营主管部门协同管理全国中药品种的保护工作。
第二章 中药保护品种等级的划分和审批
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。经国务院卫生行政部门认定，列为省、自治区、直辖市药品标准的品种，也可以申请保护。
受保护的中药品种分为一、二级。
第六条 符合下列条件之一的中药品种，可以申请一级保护：
（一）对特定疾病有特殊疗效的；
（二）相当于国家一级保护野生药材物种的人工制成品；
（三）用于预防和治疗特殊疾病的。
第七条 符合下列条件之一的中药品种，可以申请二级保护：
（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；
（二）对特定疾病有显著疗效的；
（三）从天然药物中提取的有效物质及特殊制剂。
第八条 国务院卫生行政部门批准的新药，按照国务院卫生行政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，在国务院卫生行政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。
第九条 申请办理中药品种保护的程序：
（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、直辖市中药生产经营主管部门提出申请，经中药生产经营主管部门签署意见后转送同级卫生行政部门，由省、自治区、直辖市卫生行政部门 初审签署意见后，报国务院卫生行政部门。特殊情况下，中药生产企业也可以直接向国家中药生产经营主管部门提出申请，由国家中药生产经营主管部门签署意见后 转送国务院卫生行政部门，或者直接向国务院卫生行政部门提出申请。
（二）国务院卫生行政部门委托国家中药品种保护审评委员会负责对申请保护的中药品种进行审评。国家中药品种保护审评委员会应当自接到申请报告书之日起六个月内做出审评结论。
（三）根据国家中药品种保护审评委员会的审评结论，由国务院卫生行政部门征求国家中药生产经营主管部门的意见后决定是否给予保护。批准保护的中药品种，由国务院卫生行政部门发给《中药保护品种证书》。
国务院卫生行政部门负责组织国家中药品种保护审评委员会，委员会成员由国务院卫生行政部门与国家中药生产经营主管部门协商后，聘请中医药方面的医疗、科研、检验及经营、管理专家担任。
第十条 申请中药品种保护的企业，应当按照国务院卫生行政部门的规定，向国家中药品种保护审评委员会提交完整的资料。
第十一条 对批准保护的中药品种以及保护期满的中药品种，由国务院卫生行政部门在指定的专业报刊上予以公告。