| Request for Public Comments on the Medicinal Product Administration Law (Amendment Bill) | | 药品管理法（修正草案）征求意见 |
| (11/1/2018–12/1/2018) | | （2018-11-01至2018-12-01） |
| The Standing Committee of the Thirteenth National People's Congress deliberated at its 6th session the Medicinal Product Administration Law of the People's Republic of China (Amendment Bill). The Medicinal Product Administration Law of the People's Republic of China (Amendment Bill) is hereby published on the website of the National People's Congress, and the public may directly post comments on the website of the National People's Congress (www.npc.gov.cn) or submit comments by mail to the Legislative Affairs Commission of the Standing Committee of the National People's Congress (at 1 Qianmen West Avenue, Xicheng District, Beijing, 100805. Please mark on the envelope “Request for Public Comments on the Medicinal Product Administration Law Amendment Bill”). Comments must be received on or before December 1, 2018. | | 第十三届全国人大常委会第六次会议对《中华人民共和国药品管理法（修正草案）》进行了审议。现将《中华人民共和国药品管理法（修正草案）》在中国人大网公布，社会公众可以直接登录中国人大网（www.npc.gov.cn）提出意见，也可以将意见寄送全国人大常委会法制工作委员会（北京市西城区前门西大街1号，邮编：100805。信封上请注明药品管理法修正草案征求意见）。征求意见截止日期：2018年12月01日。 |
| Medicinal Product Administration Law (Amendment Bill) | | 中华人民共和国药品管理法（修正草案） |
| I. One article is added as Article 5: “The state shall implement a marketing authorization holder system for medicinal products. Marketing authorization holders shall ensure the safety and efficacy of medicinal products, and be responsible for the whole process of research, development, manufacture, distribution, and use of medicinal products. | | 一、增加一条，作为第五条：“国家实行药品上市许可持有人制度。药品上市许可持有人应当保证药品安全、有效，对药品研制、生产、经营、使用全过程依法承担责任。 |
| “The research, development, manufacture, distribution, and use of medicinal products shall comply with laws, regulations, standards, and specifications, and the authenticity, accuracy, integrity, and traceability of data during the whole process shall be ensured.” | | “从事药品研制、生产、经营、使用活动，应当遵守法律、法规、标准和规范，保证全过程数据真实、准确、完整和可追溯。” |
| II. Article 5 is renumbered as Article 6, paragraphs 2 and 3 of which are amended to read: “The department charged with the supervision and administration of medicinal products of a local people's government at or above the county level shall undertake the supervision and administration of medicinal products within its administrative region. The relevant departments of a local people's government at or above the county level shall be responsible for supervision and administration related to medicinal products within their respective functions. | | 二、第五条改为第六条，将第二款、第三款修改为：“县级以上地方人民政府负责药品监督管理的部门承担本行政区域内的药品监督管理工作。县级以上地方人民政府有关部门在各自的职责范围内负责与药品有关的监督管理工作。 |
| “The medicinal product regulatory department of the State Council shall cooperate with the relevant departments of the State Council in implementing the general plans for pharmaceutical industry development and industry policies formulated by the state." | | “国务院药品监督管理部门应当配合国务院有关部门，执行国家制定的药品行业发展规划和产业政策。” |
| III. One article is added as Article 7: “Local people's governments at and above the county level shall be responsible for the supervision and administration of medicinal products within their respective administrative regions, lead and organize in a unified manner the supervision and administration of medicinal products as well as medicinal product safety emergency response work within their respective administrative regions, establish and improve their supervision and administration working mechanisms and information sharing mechanisms for medicinal products, include medicinal product safety work in the national economic and social development plans at their respective levels, list the funding for medicinal product safety work in their respective budgets, strengthen their capacity building for supervision and administration of medicinal products, and provide guarantees for medicinal product safety work.” | | 三、增加一条，作为第七条：“县级以上地方人民政府对本行政区域内的药品监督管理工作负责，统一领导、组织本行政区域内的药品监督管理工作以及药品安全突发事件应对工作，建立健全药品监督管理工作机制和信息共享机制，将药品安全工作列入本级国民经济和社会发展规划，将药品安全工作经费纳入本级政府预算，加强药品监督管理能力建设，为药品安全工作提供保障。” |
| IV. Article 8 is renumbered as Article 10, subparagraph (4) of which is amended to read: “It has the rules and regulations to assure quality of medicinal products, and complies with the requirements of the Good Manufacturing Practice for Medicinal Products (“GMP”) developed by the medicinal product regulatory department of the State Council in accordance with this Law.“ | | 四、第八条改为第十条，将第四项修改为：“具有保证药品质量的规章制度，并符合国务院药品监督管理部门依据本法制定的《药品生产质量管理规范》的要求”。 |
| V. Article 9 is renumbered as Article 11 and amended to read: “One engaged in the manufacture of medicinal products must comply with the GMP, establish and improve a manufacturing quality management system, and ensure the continuing compliance of the whole process of manufacture of medicinal productions with the statutory requirements. | | 五、第九条改为第十一条，修改为：“从事药品生产活动，必须符合《药品生产质量管理规范》，建立健全生产质量管理体系，保证药品生产全过程持续符合法定要求。 |
| “The legal representative or the primary person in charge of a manufacturer of medicinal products shall be fully responsible for the enterprise's manufacture of medicinal products.” | | “药品生产企业的法定代表人或者主要负责人对本企业的药品生产活动全面负责。” |
| VI. Article 10 is renumbered as Article 12, and Article 52 is renumbered as Article 57, in which "manufacturers of medicinal products" is deleted. | | 六、第十条改为第十二条，第五十二条改为第五十七条，删去其中的“药品生产企业”。 |
| Article 54 is renumbered as Article 59, Article 58 is renumbered as Article 63, and Article 92 is renumbered as Article 107, in which "manufacturer" is replaced with "marketing authorization holder, manufacturer.” | | 第五十四条改为第五十九条，第五十八条改为第六十三条，第九十二条改为第一百零七条，将其中的“生产企业”修改为“上市许可持有人、生产企业”。 |
| Article 55 is renumbered as Article 60, and Article 56 is renumbered as Article 61, in which “price department” is replaced with “medicinal product price department,” and “manufacturer” is replaced with “marketing authorization holder, manufacturer.” | | 第五十五条改为第六十条，第五十六条改为第六十一条，将其中的“价格主管部门”修改为“药品价格主管部门”，将其中的“生产企业”修改为“上市许可持有人、生产企业”。 |
| Article 68 is renumbered as Article 78, Article 70 is renumbered as Article 80, and Article 71 is renumbered as Article 82, in which “manufacturers of medicinal products” is replaced with “marketing authorization holders, manufacturers of medicinal products.” | | 第六十八条改为第七十八条，第七十条改为第八十条，第七十一条改为第八十二条，将其中的“药品生产企业”修改为“药品上市许可持有人、药品生产企业”。 |
| Article 90 is renumbered as Article 105, in paragraph 1 of which “manufacturer” is replaced with “marketing authorization holder or manufacturer,” and in paragraph 2 of which “manufacturer of medicinal products” is replaced with “marketing authorization holders, manufacturers of medicinal products.” | | 第九十条改为第一百零五条，将第一款中的“生产企业”修改为“上市许可持有人、生产企业”，将第二款中的“药品生产企业”修改为“药品上市许可持有人、药品生产企业”。 |
| VII. Article 11 is renumbered as Article 13, and one paragraph is added as paragraph 2: “In the manufacture of medicinal products, the suppliers of raw materials and inactive ingredients, among others, shall be examined as required to ensure that the raw materials and inactive ingredients, among others, purchased and used satisfy the requirements for medicinal use and the relevant requirements of the GMP.” | | 七、第十一条改为第十三条，增加一款作为第二款：“生产药品，应当按照规定对原料、辅料等进行供应商审核，保证购进、使用的原料、辅料等符合药用要求和《药品生产质量管理规范》的有关要求。” |
| XIII. Article 12 is renumbered as Article 14 and amended to read: “A marketing authorization holder or a manufacturer of medicinal products must conduct quality inspection and review on its medicinal products; and those in nonconformity with the national medicinal product standards or not processed in accordance with the processing specifications developed by the medicinal product regulatory department of the people's government of a province, autonomous region, or municipality directly under the Central Government shall not leave the factory or be marketed. | | 八、第十二条改为第十四条，修改为：“药品上市许可持有人、药品生产企业必须对药品进行质量检验、审核；不符合国家药品标准或者不按照省、自治区、直辖市人民政府药品监督管理部门制定的中药饮片炮制规范炮制的，不得出厂、上市。 |
| “A manufacturer of medicinal products shall establish the rules and procedures for the release of ex-factory medicinal products, specify the standards and conditions for ex-factory release, and conduct quality inspection on medicinal products; and those meeting the standards and conditions may be released upon signature of the qualified person. | | “药品生产企业应当建立药品出厂放行规程，明确出厂放行的标准、条件，对药品进行质量检验；符合标准、条件的，经质量负责人签字后方可放行。 |
| “A marketing authorization holder shall establish the rules and procedures for the release of medicinal products to be placed on the market, review the ex-factory medicinal products released by a manufacturer of medicinal products, and grant release only upon signature of the qualified person.” | | “药品上市许可持有人应当建立药品上市放行规程，对药品生产企业出厂放行的药品进行审核，经质量负责人签字后方可放行。” |
| IX. Article 13 is deleted. | | 九、删去第十三条。 |
| X. Article 14 is renumbered as Article 15, in paragraph 1 of which “local medicinal product regulatory department at or above the county level” is replaced with “department charged with the supervision and administration of medicinal products of a local people's government at or above the county level,” and in paragraph 3 of which “Article 15” is replaced with “Article 16.” | | 十、第十四条改为第十五条，将第一款中的“县级以上地方药品监督管理部门”修改为“县级以上地方人民政府负责药品监督管理的部门”，将第三款中的“第十五条”修改为“第十六条”。 |
XI. Article 15 is renumbered as Article 16, subparagraph (4) of which is amended to read: “It has the rules and regulations to assure quality of the medicinal products distributed, and satisfy the requirements of the Good Supply Practice for Medicinal Products | | 十一、第十五条改为第十六条，将第四项修改为：“具有保证所经营药品质量的规章制度，并符合国务院药品监督管理部门依据本法制定的《药品经营质量管理规范》的要求”。 |
| XII. Article 16 is renumbered as Article 17 and amended to read: “One engaged in the distribution of medicinal products must comply with the GSP, establish and improve a quality management system for the distribution of medicinal products, and ensure the continuing compliance of the whole process of distribution of medicinal productions with the statutory requirements. | | 十二、第十六条改为第十七条，修改为：“从事药品经营活动，必须符合《药品经营质量管理规范》，建立健全经营质量管理体系，保证药品经营全过程持续符合法定要求。 |
| “The legal representative or the primary person in charge of a distributor of medicinal products shall be fully responsible for the enterprise's distribution of medicinal products.” | | “药品经营企业的法定代表人或者主要负责人对本企业的药品经营活动全面负责。” |
| XIII. Article 29 is renumbered as Article 30 and amended to read: “For the research and development of a new medicinal product, the research and development methods, quality indicators, results of pharmacological and toxicological tests, and other relevant information and samples must be truthfully reported in accordance with the rules of the medicinal product regulatory department of the State Council, and a clinical trial may be conducted only upon approval of the medicinal product regulatory department of the State Council. The medicinal product regulatory department of the State Council shall, within 60 working days of accepting an application for a clinical trial, decide whether to grant the application and notify the applicant, and shall be deemed to have granted the application if the applicant is not notified within the time limit. | | 十三、第二十九条改为第三十条，修改为：“研制新药，必须按照国务院药品监督管理部门的规定如实报送研制方法、质量指标、药理及毒理试验结果等有关资料和样品，经国务院药品监督管理部门批准后，方可进行临床试验。国务院药品监督管理部门应当自受理临床试验申请之日起六十个工作日内决定是否同意并通知申请人；逾期未通知的，视为同意。 |
| “Pharmaceutical clinical trials shall be conducted in clinical trial institutions which meet the corresponding conditions. Pharmaceutical clinical trial institutions shall be subject to recordation management, and the specific measures shall be developed jointly by the medicinal product regulatory department of the State Council and the health department of the State Council.” | | “开展药物临床试验，应当在具备相应条件的临床试验机构进行。药物临床试验机构实行备案管理，具体办法由国务院药品监督管理部门、国务院卫生行政部门共同制定。” |
| XIV. Article 31 is renumbered as Article 32 and amended to read: “Medicinal products manufactured or sold in China must be subject to the approval of the medicinal product regulatory department of the State Council, except for traditional Chinese medicinal materials and decoction pieces not subject to approval management. The catalogs of traditional Chinese medicinal materials and decoction pieces subject to approval management shall be developed by the medicinal product regulatory department of the State Council in conjunction with the traditional Chinese medicine department of the State Council. In the process of approval, the medicinal product regulatory department of the State Council shall, in addition to the safety and efficacy of a medicinal product, examine the capabilities of quality management, risk prevention and control, and payment of damages, among others, to ensure the safety and efficacy of the medicinal product, and if conditions are met, issue a registration certificate for the medicinal product. One that has obtained a registration certificate for a medicinal product shall be the marketing authorization holder for the medicinal product. | | 十四、第三十一条改为第三十二条，修改为：“在我国境内生产、销售的药品，须经国务院药品监督管理部门批准，但是未实施审批管理的中药材和中药饮片除外。实施审批管理的中药材、中药饮片品种目录由国务院药品监督管理部门会同国务院中医药管理部门制定。国务院药品监督管理部门审批时，除审查药品的安全性、有效性外，还应当对申请人保障药品安全性、有效性的质量管理、风险防控和责任赔偿等能力进行审查，符合条件的，发给药品注册证书。取得药品注册证书的，为药品上市许可持有人。 |
| “Where a marketing authorization holder is an overseas enterprise, it shall set up a representative office in China or designate a corporate enterprise in China as its agent to perform the obligations of the marketing authorization holder and jointly assume the liabilities of the marketing authorization holder. | | “药品上市许可持有人为境外企业的，应当在我国境内设立代表机构或者指定我国境内企业法人作为代理人，履行药品上市许可持有人的义务，共同承担药品上市许可持有人的责任。 |
| “A manufacturer of traditional Chinese medicinal decoction pieces shall perform the relevant obligations of a marketing authorization holder, and be responsible for the manufacture and sale of and the reporting of adverse reactions to decoction pieces; and shall establish a quality traceability system of decoction pieces, implement the whole process management of the manufacture and sale of decoction pieces, and ensure the safety and efficacy of decoction pieces. | | “中药饮片生产企业履行药品上市许可持有人的相关义务，对中药饮片的生产、销售、不良反应报告等负责；建立中药饮片质量追溯体系，对中药饮片生产、销售实行全过程管理，保证中药饮片安全、有效。 |
| “The legal representative or the primary person in charge of a marketing authorization holder shall be fully responsible for medicinal product quality. | | “药品上市许可持有人的法定代表人或者主要负责人对药品质量全面负责。 |
| “The specific administrative measures for marketing authorization holders shall be developed by the medicinal product regulatory department of the State Council.” | | “药品上市许可持有人的具体管理办法由国务院药品监督管理部门制定。” |
| XV. One article is added as Article 33: “A marketing authorization holder shall obtain a manufacturing permit for medicinal products in accordance with the provisions of this Law if it manufactures the registered medicinal product itself; or if it outsources the manufacture of the registered medicinal product, select a manufacturer of medicinal products which meets the prescribed conditions. Marketing authorization holders may not outsource the manufacture of vaccines, blood products, narcotic drugs, psychotropic substances, and poisonous substances for medical use; except as permitted under the rules of the medicinal product regulatory department of the State Council. | | 十五、增加一条，作为第三十三条：“药品上市许可持有人自行生产药品的，应当依照本法规定取得《药品生产许可证》；委托生产的，应当选择符合条件的药品生产企业。疫苗、血液制品、麻醉药品、精神药品、医疗用毒性药品不得委托生产；但是，国务院药品监督管理部门规定可以委托生产的情形除外。 |
| “A marketing authorization holder shall meet the conditions for distribution of medicinal products as set forth in this Law if it distributes the registered medicinal product itself; or if it outsources the distribution, select a distributor of medicinal products which meets the prescribed conditions.” | | “药品上市许可持有人自行经营药品的，应当具备本法规定的药品经营的条件；委托经营的，应当选择符合条件的药品经营企业。” |
| XVI. One article is added as Article 34: “A marketing authorization holder shall develop a risk management and control plan for medicinal products, establish an annual reporting system, and annually report its manufacture and sale of medicinal products, post-market studies, risk management, and other information to the medicinal product regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government as required.” | | 十六、 |
| XVII. One article is added as Article 35: “Marketing authorization holders, manufacturers and distributors of medicinal products, and medical institutions shall establish and implement a strict medicinal product quality and safety traceability system, and ensure the traceability of medicinal products. | | 十七、增加一条，作为第三十五条：“药品的上市许可持有人、生产企业、经营企业、医疗机构应当建立并实施严格的药品质量安全追溯制度，保证药品可追溯。 |
| “In the process of research, development, manufacture, and distribution of vaccines and vaccination, traceability information shall be collected and preserved by information technology means.” | | “在疫苗的研制、生产、流通、预防接种过程中应当采用信息化手段采集、留存追溯信息。” |
| XVIII. One article is added as Article 36: “The state shall implement a compulsory vaccine liability insurance system. The marketing authorization holder for a vaccine shall take out insurance in accordance with the relevant provisions issued by the state.” | | 十八、增加一条，作为第三十六条：“国家实行疫苗责任强制保险制度。疫苗的上市许可持有人应当按照国家有关规定投保。” |
| XIX Article 32 is renumbered as Article 37, in paragraph 1 of which “Article 10” is replaced with “Article 12,” and paragraph 3 of which is amended to read: “The medicinal product regulatory department of the State Council shall, in conjunction with the health department of the State Council, organize a pharmacopoeia committee responsible for the development and revision of the national medicinal product standards." | | 十九、第三十二条改为第三十七条，将第一款中的“第十条”修改为“第十二条”，将第三款修改为：“国务院药品监督管理部门会同国务院卫生行政部门组织药典委员会，负责国家药品标准的制定和修订。” |
| XX. Article 33 is renumbered as Article 38, to which one paragraph is added as paragraph 2: “A marketing authorization holder shall, according to the requirements of the medicinal product regulatory department of the State Council, conduct reevaluation of the safety and efficacy of the marketed medicinal products.” | | 二十、第三十三条改为第三十八条，增加一款作为第二款：“药品上市许可持有人应当按照国务院药品监督管理部门的要求，对已上市药品的安全性、有效性开展再评价。” |
| XXI. Article 34 is renumbered as Article 39 and amended to read: “Marketing authorization holders, manufacturers and distributors of medicinal products, and medical institutions must purchase medicinal products from marketing authorization holders or enterprises qualified for the manufacture or distribution of medicinal products; except for the purchase of traditional Chinese medicinal materials not subject to approval management.” | | 二十一、第三十四条改为第三十九条，修改为：“药品上市许可持有人、药品生产企业、药品经营企业、医疗机构必须从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品；但是，购进未实施审批管理的中药材除外。” |
| XXII. Article 39 is renumbered as Article 44, in paragraph 1 of which “registered certificate for the imported medicinal product” is replaced with “registration certificate for the medicinal product.” | | 二十二、第三十九条改为第四十四条，将第一款中的“进口药品注册证书”修改为“药品注册证书”。 |
| Article 42 is renumbered as Article 47, in which “approval numbers or registered certificates for the imported medicinal products” is replaced with “registration certificates for the medicinal products.” | | 第四十二条改为第四十七条，将其中的“批准文号或者进口药品注册证书”修改为“药品注册证书”。 |
| XXIII. Article 40 is renumbered as Article 45, in paragraphs 1 and 2 of which “medicinal product regulatory department of the place where the port is located” is replaced with “department charged with the supervision and administration of medicinal products of the place where the port is located,” and in paragraph 2 of which “and collect testing fees according to the provision of paragraph 2 of Article 41 of this Law” is deleted. | | 二十三、第四十条改为第四十五条，将第一款、第二款中的“口岸所在地药品监督管理部门”修改为“口岸所在地负责药品监督管理的部门”，删去第二款中的“并依照本法第四十一条第二款的规定收取检验费”。 |
| XXIV. Article 41 is renumbered as Article 46, paragraph 2 of which is deleted. | | 二十四、第四十一条改为第四十六条，删去第二款。 |
XXV. Article 43 is renumbered as Article 48 and amended to read: “The state shall implement a medicinal product reserve system, and establish medicinal product reserves at both central and local levels.
．．．．．． | | 二十五、第四十三条改为第四十八条，修改为：“国家实行药品储备制度，建立中央和地方两级药品储备。 |
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