KYB CHINA(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)
(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 on Amending Certain Administrative Regulations on September 18, 2018)
总则
General Provisions
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。
These Regulations are formulated to improve the quality of traditional Chinese medicine varieties, protect the legitimate rights and interests of traditional Chinese medicine production enterprises, and promote the development of the traditional Chinese medicine industry.
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。
These Regulations apply to traditional Chinese medicine varieties manufactured within the territory of China, including Chinese patent medicines, extracts of natural medicines and their preparations, and artificially manufactured traditional Chinese medicine products.
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。
Traditional Chinese medicine varieties for which a patent is applied shall be handled in accordance with the provisions of the Patent Law and shall not be subject to these Regulations.
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。
The State encourages the research and development of clinically effective traditional Chinese medicine varieties and implements a graded protection system for traditional Chinese medicine varieties with stable quality and definite efficacy.
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。
The drug regulatory department of the State Council shall be responsible for the supervision and administration of the protection of traditional Chinese medicine varieties nationwide.
中药保护品种等级的划分和审批
Classification and Examination of Protected Traditional Chinese Medicine Varieties
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。
Traditional Chinese medicine varieties protected under these Regulations must be varieties included in the national drug standards. Varieties listed in the drug standards of provinces, autonomous regions, or municipalities directly under the Central Government, as determined by the drug regulatory department of the State Council, may also apply for protection.
受保护的中药品种分为一、二级。
Protected traditional Chinese medicine varieties are divided into Grade 1 and Grade 2.
符合下列条件之一的中药品种，可以申请一级保护：
Traditional Chinese medicine varieties meeting one of the following conditions may apply for Grade 1 protection:
(一)对特定疾病有特殊疗效的；
(1) Having special therapeutic effects on specific diseases;
(二)相当于国家一级保护野生药材物种的人工制成品；
(2) Being artificially manufactured products equivalent to Grade 1 nationally protected wild medicinal species;
(三)用于预防和治疗特殊疾病的。
(3) Being used for the prevention and treatment of special diseases.
符合下列条件之一的中药品种，可以申请二级保护：
Traditional Chinese medicine varieties meeting one of the following conditions may apply for Grade 2 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；
(1) Varieties that meet the conditions of Article 6 of these Regulations or varieties for which Grade 1 protection has been lifted;
(二)对特定疾病有显著疗效的；
(2) Having significant therapeutic effects on specific diseases;
(三)从天然药物中提取的有效物质及特殊制剂。
(3) Effective substances extracted from natural medicines and special preparations thereof.
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。
New drugs approved by the drug regulatory department of the State Council shall be granted protection in accordance with the protection period prescribed by the drug regulatory department of the State Council; among them, those meeting the conditions of Articles 6 and 7 of these Regulations may reapply for protection in accordance with these Regulations six months before the expiration of the protection period approved by the drug regulatory department of the State Council.
申请办理中药品种保护的程序：
The procedures for applying for protection of traditional Chinese medicine varieties are as follows:
(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。
(1) A traditional Chinese medicine production enterprise may submit an application for a traditional Chinese medicine variety it produces that meets the requirements of Articles 5, 6, 7, and 8 of these Regulations to the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located. The drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall conduct a preliminary examination and, after signing its opinion, report to the drug regulatory department of the State Council. Under special circumstances, the traditional Chinese medicine production enterprise may also directly submit an application to the drug regulatory department of the State Council.
(二)国务院药品监督管理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作出审评结论。
(2) The drug regulatory department of the State Council shall entrust the National Traditional Chinese Medicine Variety Protection Review Committee to be responsible for the review of traditional Chinese medicine varieties applying for protection. The National Traditional Chinese Medicine Variety Protection Review Committee shall make a review conclusion within six months from the date of receiving the application report.
(三)根据国家中药品种保护审评委员会的审评结论，由国务院药品监督管理部门决定是否给予保护。批准保护的中药品种，由国务院药品监督管理部门发给《中药保护品种证书》。
(3) Based on the review conclusion of the National Traditional Chinese Medicine Variety Protection Review Committee, the drug regulatory department of the State Council shall decide whether to grant protection. For traditional Chinese medicine varieties approved for protection, the drug regulatory department of the State Council shall issue a "Certificate of Protected Traditional Chinese Medicine Variety."
国务院药品监督管理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药品监督管理部门聘请中医药方面的医疗、科研、检验及经营、管理专家担任。
The drug regulatory department of the State Council shall be responsible for organizing the National Traditional Chinese Medicine Variety Protection Review Committee, whose members shall be appointed by the drug regulatory department of the State Council from experts in traditional Chinese medicine medical treatment, scientific research, testing, operation, and management.
申请中药品种保护的企业，应当按照国务院药品监督管理部门的规定，向国家中药品种保护审评委员会提交完整的资料。
An enterprise applying for protection of a traditional Chinese medicine variety shall submit complete materials to the National Traditional Chinese Medicine Variety Protection Review Committee in accordance with the provisions of the drug regulatory department of the State Council.
对批准保护的中药品种以及保护期满的中药品种，由国务院药品监督管理部门在指定的专业报刊上予以公告。
For traditional Chinese medicine varieties approved for protection and those whose protection period has expired, the drug regulatory department of the State Council shall announce them in designated professional newspapers and periodicals.
中药保护品种的保护
Protection of Protected Traditional Chinese Medicine Varieties
中药保护品种的保护期限：
The protection periods for protected traditional Chinese medicine varieties are as follows:
中药一级保护品种分别为三十年、二十年、十年。
Grade 1 protected traditional Chinese medicine varieties shall be 30 years, 20 years, or 10 years, respectively.
中药二级保护品种为七年。
Grade 2 protected traditional Chinese medicine varieties shall be 7 years.
中药一级保护品种的处方组成、工艺制法，在保护期限内由获得《中药保护品种证书》的生产企业和有关的药品监督管理部门及有关单位和个人负责保密，不得公开。
The prescription composition and technological process of Grade 1 protected traditional Chinese medicine varieties shall be kept confidential by the production enterprise that has obtained the "Certificate of Protected Traditional Chinese Medicine Variety," the relevant drug regulatory departments, and relevant units and individuals during the protection period, and shall not be disclosed.
负有保密责任的有关部门、企业和单位应当按照国家有关规定，建立必要的保密制度。
The relevant departments, enterprises, and units with confidentiality obligations shall establish necessary confidentiality systems in accordance with relevant state regulations.
向国外转让中药一级保护品种的处方组成、工艺制法的，应当按照国家有关保密的规定办理。
The transfer of the prescription composition and technological process of Grade 1 protected traditional Chinese medicine varieties to foreign countries shall be handled in accordance with the relevant state provisions on confidentiality.
中药一级保护品种因特殊情况需要延长保护期限的，由生产企业在该品种保护期满前六个月，依照本条例第九条规定的程序申报。延长的保护期限由国务院药品监督管理部门根据国家中药品种保护审评委员会的审评结果确定；但是，每次延长的保护期限不得超过第一次批准的保护期限。
If a Grade 1 protected traditional Chinese medicine variety needs to extend its protection period due to special circumstances, the production enterprise shall apply six months before the expiration of the protection period for that variety in accordance with the procedures specified in Article 9 of these Regulations. The extended protection period shall be determined by the drug regulatory department of the State Council based on the review results of the National Traditional Chinese Medicine Variety Protection Review Committee; however, each extension shall not exceed the initially approved protection period.
中药二级保护品种在保护期满后可以延长七年。
The protection period for Grade 2 protected traditional Chinese medicine varieties may be extended for 7 years after expiration.
申请延长保护期的中药二级保护品种，应当在保护期满前六个月，由生产企业依照本条例第九条规定的程序申报。
For Grade 2 protected traditional Chinese medicine varieties applying for extension of the protection period, the production enterprise shall apply six months before the expiration of the protection period in accordance with the procedures specified in Article 9 of these Regulations.
被批准保护的中药品种，在保护期内限于由获得《中药保护品种证书》的企业生产；但是，本条例第十九条另有规定的除外。
Approved protected traditional Chinese medicine varieties shall, during the protection period, be limited to production by the enterprise that has obtained the "Certificate of Protected Traditional Chinese Medicine Variety"; however, Article 19 of these Regulations provides otherwise.
国务院药品监督管理部门批准保护的中药品种如果在批准前是由多家企业生产的，其中未申请《中药保护品种证书》的企业应当自公告发布之日起六个月内向国务院药品监督管理部门申报，并依照本条例第十条的规定提供有关资料，由国务院药品监督管理部门指定药品检验机构对该申报品种进行同品种的质量检验。国务院药品监督管理部门根据检验结果，可以采取以下措施：
If a traditional Chinese medicine variety approved for protection by the drug regulatory department of the State Council was produced by multiple enterprises before approval, the enterprises that have not applied for the "Certificate of Protected Traditional Chinese Medicine Variety" shall, within six months from the date of the announcement, submit an application to the drug regulatory department of the State Council and provide relevant materials in accordance with Article 10 of these Regulations. The drug regulatory department of the State Council shall designate a drug testing institution to conduct quality testing of the same variety for the declared variety. Based on the test results, the drug regulatory department of the State Council may take the following measures:
(一)对达到国家药品标准的，补发《中药保护品种证书》。
(1) For those meeting the national drug standards, issue a "Certificate of Protected Traditional Chinese Medicine Variety" retroactively.
(二)对未达到国家药品标准的，依照药品管理的法律、行政法规的规定撤销该中药品种的批准文号。
(2) For those not meeting the national drug standards, revoke the approval number of the traditional Chinese medicine variety in accordance with the provisions of drug administration laws and administrative regulations.
对临床用药紧缺的中药保护品种的仿制，须经国务院药品监督管理部门批准并发给批准文号。仿制企业应当付给持有《中药保护品种证书》并转让该中药品种的处方组成、工艺制法的企业合理的使用费，其数额由双方商定；双方不能达成协议的，由国务院药品监督管理部门裁决。
The imitation of protected traditional Chinese medicine varieties that are in short supply for clinical use shall be approved by the drug regulatory department of the State Council and an approval number shall be issued. The imitating enterprise shall pay a reasonable usage fee to the enterprise that holds the "Certificate of Protected Traditional Chinese Medicine Variety" and transfers the prescription composition and technological process of the traditional Chinese medicine variety. The amount shall be negotiated by both parties; if the parties cannot reach an agreement, the drug regulatory department of the State Council shall make a ruling.
生产中药保护品种的企业应当根据省、自治区、直辖市人民政府药品监督管理部门提出的要求，改进生产条件，提高品种质量。
Enterprises producing protected traditional Chinese medicine varieties shall improve production conditions and enhance variety quality in accordance with the requirements put forward by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government.
中药保护品种在保护期内向国外申请注册的，须经国务院药品监督管理部门批准。
If a protected traditional Chinese medicine variety is to be registered abroad during the protection period, approval from the drug regulatory department of the State Council shall be obtained.
罚则
Penalty Provisions
违反本条例第十三条的规定，造成泄密的责任人员，由其所在单位或者上级机关给予行政处分；构成犯罪的，依法追究刑事责任。
If a person responsible for a leak of confidential information violates the provisions of Article 13 of these Regulations, the person's unit or superior authority shall impose administrative sanctions; if the act constitutes a crime, criminal liability shall be pursued in accordance with the law.
违反本条例第十七条的规定，擅自仿制中药保护品种的，由县级以上人民政府负责药品监督管理的部门以生产假药依法论处。
If anyone, in violation of the provisions of Article 17 of these Regulations, imitates a protected traditional Chinese medicine variety without authorization, the drug regulatory department at or above the county level shall punish the act as the production of counterfeit drugs in accordance with the law.
伪造《中药品种保护证书》及有关证明文件进行生产、销售的，由县级以上人民政府负责药品监督管理的部门没收其全部有关药品及违法所得，并可以处以有关药品正品价格三倍以下罚款。
If anyone forges a "Certificate of Protected Traditional Chinese Medicine Variety" or relevant supporting documents for production or sale, the drug regulatory department at or above the county level shall confiscate all related drugs and illegal gains, and may also impose a fine of not more than three times the price of the genuine related drugs.
上述行为构成犯罪的，由司法机关依法追究刑事责任。
If the above acts constitute a crime, the judicial authorities shall pursue criminal liability in accordance with the law.
当事人对负责药品监督管理的部门的处罚决定不服的，可以依照有关法律、行政法规的规定，申请行政复议或者提起行政诉讼。
If a party is dissatisfied with the penalty decision of the drug regulatory department, it may apply for administrative reconsideration or file an administrative lawsuit in accordance with the provisions of relevant laws and administrative regulations.
附则
Supplementary Provisions
有关中药保护品种的申报要求、申报表格等，由国务院药品监督管理部门制定。
The application requirements and application forms for protected traditional Chinese medicine varieties shall be formulated by the drug regulatory department of the State Council.
本条例自一九九三年一月一日起施行。
These Regulations shall come into force as of January 1, 1993.