MAH制度呼之欲出: 国务院发布《药品上市许可持有人制度试点方案》（附法规中英文）

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随着国务院于2016年5月26日颁布《药品上市许可持有人制度试点方案》，药品上市许可持有人(Marketing Authorization Holder, MAH)制度以部分城市试点的方式落地，中国将逐步全面开启药品上市许可与生产许可分离的管理模式。与以往只有获得药品生产许可及GMP认证的药品生产企业才能申请药品注册的要求不同，根据试点方案，药品研发机构和研发人员可申请作为药品上市许可持有人，并委托药品生产企业进行商业化生产。MAH制度将实质性地提高从新药研发到商业化生产的速度。

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根据《药品上市许可持有人制度试点方案》，从即日起到 2018年11月4日，在北京、天津、河北、上海、江苏、浙江、福建、山东、广东、四川等10个省（市）开展药品上市许可持有人制度试点。试点药品范围包括新药、部分仿制药及试点方案实施前已批准上市的部分药品。

以下为《药品上市许可持有人制度试点方案》的中英文对照，英文仅供参考。

国务院办公厅关于印发药品上市许可持有人制度试点方案的通知
（国办发〔2016〕41号）

Circular of the General Office of the State Council on Issuing the Pilot Program Plan for the System of the Drug Marketing

Authorization Holders

(No. 41 [2016] of the General Office of the State Council)

各省、自治区、直辖市人民政府，国务院各部委、各直属机构：

The people's governments of all provinces, autonomous regions and municipalities; all ministries, commissions and subordinated institutions of the State Council:

《药品上市许可持有人制度试点方案》已经国务院同意，现予印发。

The Pilot Program Plan for the System of the Drug Marketing Authorization Holders has been approved by the State Council and is hereby issued as follows.

开展药品上市许可持有人制度试点是药品审评审批制度改革的一项重要内容，对于鼓励药品创新、提升药品质量具有重要意义。各有关地区要高度重视，按照试点方案要求，认真组织实施。食品药品监管总局要会同相关部门完善配套政策，加强组织指导，强化监督检查，稳妥有序推进试点工作，确保试点品种药品的质量和安全，重大情况和问题及时报告国务院。

Conducting the pilot program for the system of the drug marketing authorization holders is an important part of the reform of the drug review and approval system and is of great importance for encouraging the drug innovation and improving the drug quality. All relevant local governmentsshould pay high attention to and seriously implement the system of the drug marketing authorization holders pursuant to the requirements under the pilot program. China Food and Drug Administration ("CFDA") will work with relevant departments to improve the supporting policy, strengthen the organization and guidance, consolidate the supervision and inspection, implement the pilot program in good and steady order, ensure the quality and safety of the pilot drugs and report major issues and problems to State Council in a timely manner.

国务院办公厅

General Office of the State Council

2016年5月26日

May 26,2016

药品上市许可持有人制度试点方案

Pilot Program plan for the System of the Drug Marketing Authorization Holders

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根据《全国人民代表大会常务委员会关于授权国务院在部分地方开展药品上市许可持有人制度试点和有关问题的决定》，在北京、天津、河北、上海、江苏、浙江、福建、山东、广东、四川等10个省（市）开展药品上市许可持有人制度试点。现就做好试点工作制定以下方案。

According to the Decision of the Standing Committee of the National People's Congress on Authorizing the State Council to Conduct the Pilot Program for the System of Drug Marketing Authorization Holders in Certain Areas and the Relevant Issues, the pilot program for the system of drug marketing authorization holders (the "Pilot Program") will be held in following ten provinces and municipalities:Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan (collectively referred to as the "Pilot Area"). The following plan is made to ensure the implementation of the Pilot Program.

I.试点内容

The Content of the Pilot Program

试点行政区域内的药品研发机构或者科研人员可以作为药品注册申请人（以下简称申请人），提交药物临床试验申请、药品上市申请，申请人取得药品上市许可及药品批准文号的，可以成为药品上市许可持有人（以下简称持有人）。法律法规规定的药物临床试验和药品生产上市相关法律责任，由申请人和持有人相应承担。

Drug research and development institutions or scientific researchers in the Pilot Area are eligible to be the drug registration applicant (the "Applicant") to apply for drug clinical trialand marketing of drugs. If the Applicant obtains drug marketing authorization and drug approval numbers, the Applicant is qualifiedto be the drugmarketing authorization holder(the "Holder"). The Applicant and Holder shall assume corresponding legal liabilities for drug clinical trial and marketing of drugsunderthe laws and regulations.

持有人不具备相应生产资质的，须委托试点行政区域内具备资质的药品生产企业（以下称受托生产企业）生产批准上市的药品。持有人具备相应生产资质的，可以自行生产，也可以委托受托生产企业生产。

If the Holder does not have corresponding drug production qualifications, it should authorize a qualified drug production enterprise in the Pilot Area (the "Authorized Production Enterprise") to produce the drug approved for marketing. If the Holder has correspondingdrug production qualifications, it can produce by itself or authorize anAuthorized Production Enterprise to producethe drugs.

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在药品注册申请审批期间或批准后，申请人或持有人可以提交补充申请，变更申请人、持有人或者受托生产企业。

During the review period of the drug registration application or after getting the approval, the Applicant or Holder can submit supplemental application for changing the Applicant, Holder or Authorized Production Enterprise.

Ⅱ.试点药品范围

The Scope of Pilot Drugs

本方案实施后批准上市的新药。具体包括：1.按照现行《药品注册管理办法》注册分类申报的化学药品第1-4类、第5类（仅限靶向制剂、缓释制剂、控释制剂），中药及天然药物第1-6类，治疗用生物制品第1类、第7类和生物类似药；2.化学药品注册分类改革实施后，按照新的化学药品注册分类（以下简称新注册分类）申报的化学药品第1-2类。

New drugs approved for marketing after the implementation ofthis plan, including: (i)Class 1-4 and Class 5 (limited to targeting delivery, sustained release and controlled release preparations) of chemical drugs, Class 1-6 of traditional Chinese medicines and natural medicines, Class 1 and Class 7 of biological products for medical treatment and bio-similars that are applied for registration according to the existing registration classification under the Drug Registration Administrative Rules; and (ii)after the implementation of the classification reform of chemical drugs, Class 1-2 of chemical drugsthat are applied for registration according to new registration classification of chemical drugs (the “New Registration Classification”).

按与原研药品质量和疗效一致的新标准批准上市的仿制药。具体包括：化学药品注册分类改革实施后，按照新注册分类申报的化学药品第3-4类。

Generic drugs approved for marketing according to the new standards which have the same quality and treatment effectas the original drugs, including: Class 3-4 of chemical drugsthat are applied for registration according to New Registration Classificationafter the implementation of the classification reform of chemical drugs.

本方案实施前已批准上市的部分药品。具体包括：1.通过质量和疗效一致性评价的药品；2.试点行政区域内，药品生产企业整体搬迁或者被兼并后整体搬迁的，该企业持有药品批准文号的药品。

Certain drugs approved for marketing before the implementation of this plan,including: (i)drugs passed the consistency evaluation of quality and treatment effect; (ii)in the Pilot Area, drugs held by the enterprise which owns thedrug approval numbersas a result of the integral relocation of the drug producing enterprise, or integral relocation from the merger of the drug production enterprise.

麻醉药品、精神药品、医疗用毒性药品、放射性药品、预防用生物制品、血液制品不纳入试点药品范围。

Narcotics, psychotropic substances, toxic drugs for medicinal use, radioactive drugs, biological products for prevention and blood products are not within the scope of pilot drugs.

Ⅲ.申请人和持有人条件

Requirements for the Applicant and Holder

药品研发机构或者科研人员成为申请人和持有人的条件：

The requirements for the drug research and development institutions and scientific researchers to be the Applicant and Holder are set forth as follows:

1. 基本条件

Basic Requirements

(1)

属于在试点行政区域内依法设立且能够独立承担责任的药品研发机构，或者在试点行政区域内工作且具有中华人民共和国国籍的科研人员。

The drug research and development institutions should be duly established according to the applicable laws and regulations and could independently undertake liability in the Pilot Area;the scientific researchers should have Chinese nationality and work in the Pilot Area.

(2)

具备药品质量安全责任承担能力。

The drug research and development institutions or scientific researchers should be capable of assuming the responsibility for the quality and safety of drugs.

2.申报资料

Application Documents

(1) 资质证明文件

Qualification documents

药品研发机构应当提交合法登记证明文件（营业执照等）复印件。

The drug research and development institutions should provide the copies of incorporation documents (i.e. business license).

科研人员应当提交居民身份证复印件、个人信用报告、工作简历（包含教育背景、药品研发工作经历等信息）以及诚信承诺书。

The scientific researchers should provide copy of resident identification card, personal credit report, working resume (including educational background, working experience in the drug research and development field and other information) and statement of integrity.

(2) 药品质量安全责任承担能力相关文件

Supporting documents evidencing the capacity to assume the responsibility for the quality and safety of drugs

科研人员申请药物临床试验的，应当提交药物临床试验风险责任承诺书，承诺在临床试验开展前，向其所在地省级药品监督管理部门提交与担保人签订的担保协议或者与保险机构签订的保险合同。

Scientific researchers applying for drug clinical trial should provide the undertaking letter for the responsibility of the risks in drug clinical trial and undertake to submit the guarantee agreement entered into with guarantor or the insurance contract entered into with insurance company to the provincial CFDA where it is located before conducting the drug clinical trial.

药品研发机构或者科研人员申请成为持有人的，应当提交药品质量安全责任承诺书，承诺在药品上市销售前，向其所在地省级药品监督管理部门提交与担保人签订的担保协议或者与保险机构签订的保险合同；对于注射剂类药品，应当承诺在药品上市销售前提交保险合同。

Drug research and development institution or scientific researchers applying to be the Holders should provide letter of commitment on the quality and safety of drugs and undertake to submit the guarantee agreement entered into with guarantor or insurance contract entered into with insurance company to the provincial CFDA where it is located before putting the drug into the market for sale; for the injection drugs, it should undertake to submit insurance contract before the marketing and sales of the drugs.

Ⅳ. 受托生产企业条件

Requirements for Authorized Production Enterprise

受托生产企业为在试点行政区域内依法设立、持有相应药品生产范围的《药品生产许可证》以及药品生产质量管理规范（GMP）认证证书的药品生产企业。

Authorized Production Enterprise should be duly established in the Pilot Area in accordance with applicable laws and regulations, and hold drug production license with corresponding production scope of the drugs and the GMP certificate.

Ⅴ.申请人和持有人的义务与责任

Obligations and Responsibilities of the Applicant and Holder

履行《中华人民共和国药品管理法》（以下简称《药品管理法》）以及其他法律法规规定的有关药品注册申请人、药品生产企业在药物研发注册、生产、流通、监测与评价等方面的相应义务，并且承担相应的法律责任。

Carry out corresponding obligations as drug registration applicant and drug production enterprise under the Drug Administration Law of the People's Republic of China (the "Drug Administration Law") in respects of drug research and development and registration, production, distribution, supervision and evaluation, etc., and take corresponding legal responsibilities.

持有人应当与受托生产企业签订书面合同以及质量协议，约定双方的权利、义务与责任。

The Holder should enter into a written agreement and qualification agreement with Authorized Production Enterprise to specify the rights, obligations and responsibilities of both parties.

持有人应当委托受托生产企业或者具备资质的药品经营企业代为销售药品，约定销售相关要求，督促其遵守有关法律法规规定，并落实药品溯源管理责任。

The Holder should entrust the Authorized Production Enterprise or qualified drug trading enterprise to sell drugs, specify the relevant sales requirements and cause the Authorized Production Enterprise or qualified drug trading enterprise to act in compliance with applicable laws and regulations and implement drug traceability management responsibilities.

持有人应当通过互联网主动公开药品上市许可批准信息、药品说明书、合理用药信息等，方便社会查询。

The Holder should publicize information on the drug marketing approval, the instruction of the drugs, information about proper usage of the drugs via internet for the convenience of public enquiry.

批准上市药品造成人身损害的，受害人可以向持有人请求赔偿，也可以向受托生产企业、销售者等请求赔偿。属于受托生产企业、销售者责任，持有人赔偿的，持有人有权向受托生产企业、销售者追偿；属于持有人责任，受托生产企业、销售者赔偿的，受托生产企业、销售者有权向持有人追偿。具体按照《中华人民共和国侵权责任法》等的规定执行。

If the drug approved for marketing causes personal injury, the victim is entitled to claim for compensation from the Holder, Authorized Production Enterprise or the drug trading company. If the injury is due to the responsibility of Authorized Production Enterprise and the drug trading company, the Holder is entitled to pursue them for recovering its losses after providing the compensation. If the injury is due to the responsibility of the Holder, Authorized Production Enterprise or the drug trading company is entitled to pursue the Holder for recovering its losses after providing the compensation. The specific compensating procedures should be handled according to the Tort Law of People’s Republic of China and other regulations.

Ⅵ.受托生产企业的义务与责任

The obligation and responsibility of Authorized Production Enterprise

履行《药品管理法》以及其他法律法规规定的有关药品生产企业在药品生产方面的义务，并且承担相应的法律责任。

fulfill the obligations of drug production enterprises according to Drug Administration Law and other laws and regulations and take the corresponding legal responsibilities.

履行与持有人依法约定的相关义务，并且承担相应的法律责任。

fulfill the obligations agreed with the Holder and take the corresponding legal responsibilities.

Ⅶ.持有人的申请

Application by the Holder

新注册药品

Newly registered drugs

对于本方案实施后的新注册药品，符合试点要求的，申请人可以在提交药物临床试验申请或者药品上市申请的同时，申请成为持有人。

As to the newly registered drugs after the implementation of this plan, the Applicant can apply to be the Holder at the same time when applying for drug clinical trial or marketing of drugs if meeting the requirements of the pilot plan.

对于本方案实施前已受理临床试验申请或者上市申请、尚未批准上市的药物，符合试点要求的，申请人可以提交补充申请，申请成为持有人。

As to the drugs applied for drug clinical trial or drug marketing but have yet to be approved for marketing before the implementation of this plan, the Applicant can submit supplemental application for becoming the Holder if it meets the requirements of the pilot plan.

申请人拟委托受托生产企业生产的，在提交药品上市申请或者补充申请的同时，应当提交受托生产企业信息。

If the Applicant plans to entrust the Authorized Production Enterprise for production, it shall provide the information of the Authorized Production Enterprise at the same time of applying for drug marketing or submitting the supplemental application.

已批准上市药品

Drugs approved for marketing

对于本方案实施前已批准上市的药品，符合试点要求的，申请人可以提交补充申请，申请成为持有人。

As to the drugs that have been approved for marketing before the implementation of this plan, the Applicant can submit supplemental application to apply for being the Holder if it meets the requirements of the pilot plan.

申请人拟委托受托生产企业生产的，在提交补充申请的同时，应当提交受托生产企业信息。

变更申请

Application for alternation

持有人的药品上市申请获得批准后，可以提交补充申请，变更持有人及受托生产企业。在已受理药物临床试验申请或者药品上市申请、尚未批准阶段，申请人可以提交补充申请，变更申请人及受托生产企业。

After the Holder gets the drug marketing approval, it can submit supplemental application to change the Holder and the Authorized Production Enterprise. With respect to drug clinical trial or drug marketing application that has been accepted but yet to be approved, the Applicant can submit supplementary application to change the Applicant and the Authorized Production Enterprise.

变更持有人或者申请人的，由转让和受让双方共同向受让方所在地省级药品监督管理部门申请，由省级药品监督管理部门报食品药品监管总局审批；变更受托生产企业的，由持有人或者申请人向其所在地省级药品监督管理部门申请，由省级药品监督管理部门报食品药品监管总局审批。

In the event of change of the Applicant or the Holder, the transferor and transferee should apply to the provincial CFDA in the place where the transferee is located and the provincial CFDA should transfer the application to CFDA for approval. In the event of change of the Authorized Production Enterprise, the Holder or the Applicant should apply to the provincial CFDA and the provincial CFDA should transfer the application to CFDA for approval.

其他要求

Other requirements

试点品种药品的批准证明文件应当载明持有人、受托生产企业等相关信息，并且注明持有人应当按照相关要求向其所在地省级药品监督管理部门提交与担保人签订的担保协议或者与保险机构签订的保险合同。

The approval certificate of pilot drug should indicate the relevant information of the Holder and the Authorized Production Enterprise and specify that the Holder should provide to the provincial CFDA guarantee agreement entered into with the guarantor or insurance contract entered into with the insurance company according to the relevant requirements.

试点品种药品的说明书、包装标签中应标明持有人信息、生产企业信息等。

The instruction and packaging labels of the pilot drugs should include information of the Holder and drug production enterprise.

试点工作期间核发的药品批准文号，试点期满后，在药品注册批件载明的有效期内继续有效。

After the pilot period expires, the drug approval number granted during the pilot period will still be valid within the valid term indicated on the drug registration approval certificate.

Ⅷ. 监督管理

Supervision and Administration

1.上市后监管。

Post-market Supervision

持有人所在地省级药品监督管理部门负责对持有人及批准上市药品的监督管理，对不在本行政区域内的受托生产企业，应联合受托生产企业所在地省级药品监督管理部门进行延伸监管。加强对持有人履行保证药品质量、上市销售与服务、药品监测与评价、药品召回等义务情况的监督管理，督促持有人建立严格的质量管理体系，确保责任落实到位。

Provincial CFDA in the place where the Holder is located is in charge of supervising the Holder and drug approved for marketing, and should coordinate with the provincial CFDA in the place where the Authorized Production Enterprise is located to extend supervision if the Authorized Production Enterprise is outside its administrative area. The provincial CFDA should strengthen its supervision and administration over the fulfillment of the Holder’s obligations in relation to drug qualities, marketing sales and services, drug monitoring and valuation and drug recall, and should supervise the Holder’s establishment of stringent quality management system and ensure that undertaking of responsibilities is in place.

生产企业所在地省级药品监督管理部门应当加强对药品生产者在药品GMP条件下实施生产的监督检查，发现生产、经营环节存在风险的，及时采取控制措施。

Provincial CFDA in the place where the drug production enterprise is located should strengthen the supervision and inspection of drug production enterprise’s production activities pursuant to the GMP standards, and should take controlling measures if it finds risks in the production and trading process.

药品监督管理部门发现批准上市药品存在质量风险的，应根据实际情况对持有人及相关单位采取约谈、发告诫信、限期整改、修订药品说明书、限制使用、监督召回药品、撤销药品批准证明文件以及暂停研制、生产、销售、使用等风险控制措施。

If CFDA and its local branches find the quality risks of drugs approved for marketing, it should take interviews, send letters of caution, demand rectification within prescribed time period, revise the instruction of the drug, restrictions on the use, monitoring the recall of drugs, revocation of drug approvals and suspension of the development, production, sales, use and other risk control measures against the Holder and other relevant parties according to the actual conditions.

对于违反《药品管理法》等法律法规和本方案有关规定的持有人及受托生产企业，持有人所在地省级药品监督管理部门应当依法查处，追究相关责任人的责任。

In the event of violation of Drug Administration Law and other laws and regulations by the Holder and the Authorized Production Enterprise, the provincial CFDA in the place where the Holder is located should conduct investigation according to laws and ascertain the liability of relevant in-charge person.

2. 信息公开。

Information disclosure

食品药品监管总局应当按规定主动公开试点品种药品的受理、审评、审批、上市后变更等相关信息。

CFDA should voluntarily publicize the relevant information of pilot drugs in respects of acceptance, review, approval and post-market alteration.

省级药品监督管理部门应当主动公开持有人履行义务情况、日常监督检查情况和行政处罚等监督管理相关信息。

Provincial CFDA should voluntarily publicize the relevant information of the status of the obligation fulfillment of the Holder, result of daily supervision and inspection, administrative penalties and other supervision and administration information.

Ⅸ.其他

Others

本方案自印发之日起，实施至2018年11月4日。试点行政区域内的药品生产企业参照本方案中持有人的有关规定执行。

This plan will be effective from the date of issuance until November 4, 2018. Drug production enterprises in the Pilot Area should refer to the relevant rules on the Holder in this plan.

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本方案由食品药品监管总局负责解释。

CFDA is in charge of interpreting this plan.

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