中国医药行业投资新机遇

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In recent years, China's healthcare and pharmaceutical industry has continuously introduced various incentive policies to optimize the environment for foreign investment. Under the dual stimulation of the internal market and policies, China's healthcare and pharmaceutical industry has achieved rapid development. In 2022, China ranked among the top in the world in terms of active pharmaceutical transactions, with the total transaction value reaching 34.6 billion USD, up by 10% year-on-year[1].

This article reviews the new regulations and policies in China's healthcare and pharmaceutical industries in recent years from five aspects: (1) Reform of the regulatory system of drugs and medical devices in China; (2) Addition of new entries of the pharmaceutical industry to the Catalogue of Encouraged Foreign Investment Industries (鼓励外商投资产业目录); (3) New regulations on online drug sales; (4) Implementation of Internet hospital supervision policies; and (5) Allowance of Hong Kong and Macao MAHs (as defined below) to entrust cross-border production.

In August 2015, the State Council of the PRC issued the Opinions on the Reform of the Evaluation and Approval System for Drugs and Medical Devices (关于改革药品医疗器械审评审批制度的意见), which kicked off the regulatory system reform of drugs and medical devices. In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council further issued the Opinions on Deepening the Reform of the Evaluation and Approval System and Encouraging the Innovation of Drugs and Medical Devices (关于深化审评审批制度改革鼓励药品医疗器械创新的意见), which accelerated China's reform of the regulatory system of drugs and medical devices.

Echoing this development, the National Medical Products Administration of the PRC ("NMPA") joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ("ICH") in 2017 and was elected as a member of the ICH Management Committee in 2018, further aligning China's drug registration and administration system with international standards.

Prior to the implementation of the Plan for the Pilot Plan on Drug Marketing Authorization Holder System (药品上市许可持有人制度试点方案) ("Pilot Plan") issued in 2016, China's drug marketing authorization and manufacture license were bound to each other. In other words, only enterprises with the capacity to manufacture drugs or medical devices may be granted marketing authorization for their drugs or medical devices. After the issuance of the Pilot Plan, ten provinces (municipalities), including Beijing, Shanghai, and Guangdong, implemented a new drug marketing authorization holder system on a trial basis, under which the marketing authorization and the manufacture license are independent of each other ("MAH System"). After the new Drug Administration Law of the People's Republic of China ("Drug Administration Law") came into force on December 1, 2019, China fully implemented the MAH System nationwide.

Under the MAH system, an enterprise or a drug research and development institution without manufacturing capacity can also be a drug marketing authorization holder ("MAH"). Except for drugs that are explicitly prohibited by law from manufacture entrustment[2], MAHs are allowed to entrust enterprises with the corresponding manufacturing qualifications to manufacture all other drugs. However, MAHs still need to be responsible for non-clinical research, clinical trial, manufacture and distribution, post-marketing research, and monitoring, reporting and handling of adverse drug events, etc[3].

Similar to the drug MAH System, the newly revised Regulations on the Supervision and Administration of Medical Devices (医疗器械监督管理条例), which came into force on June 1, 2021, also implemented, on a nationwide basis, a medical device registrant (filing applicant) system under which the marketing authorization and the manufacture license are independent of each other. In addition, the Drug Administration Law newly revised in 2019 has, for the first time, clarified the transferability of drug marketing authorizations on the legislative level[4], making marketing authorization of drugs one of the newest forms of transferrable assets. However, up to now, there is no explicit legal basis for the transfer of marketing authorizations for medical devices in China.

In recent years, in addition to the fundamental laws and regulations in the regulatory system of drugs and medical devices, NMPA has revised and improved a series of supporting regulations, including Provisions for Drug Registration (药品注册管理办法), Provisions for the Supervision and Administration of Drug Manufacturing (药品生产监督管理办法), Provisions for Medical Device Registration and Filing (医疗器械注册与备案管理办法), Provisions for Supervision and Administration of Medical Device Manufacturing (医疗器械生产监督管理办法), etc. Today, China's regulatory system of drugs and medical devices has undergone profound changes and is further in line with international practices.

1.What preferential policies are foreign investors entitled to by investing in the industries set out in the Catalogue of Encouraged Foreign Investment Industries?

The industrial regulatory policies for foreign investment in China include not only the "negative list" for prohibited and restricted industries, but also the "encouraged catalogue". As one of China's major policies to promote foreign investment, foreign investors investing in the industries listed in the Catalogue of Encouraged Foreign Investment Industries can mainly benefit from the following three policies[5]:

2.What are the changes in the pharmaceutical industries in the latest version of the Catalogue of Encouraged Foreign Investment Industries?

The latest version of the Catalogue of Encouraged Foreign Investment Industries ("Catalogue 2022") was issued by the PRC National Development and Reform Commission and the PRC Ministry of Commerce on October 26, 2022 and came into force on January 1, 2023. The main structure of Catalogue 2022 remains unchanged compared with the 2020 version and consists of two parts: (1) the National Catalogue of Encouraged Industries for Foreign Investment (全国鼓励外商投资产业目录), which applies to foreign investment in the whole country; and (2) the Catalogue of Industries for Foreign Investment in Central and Western China (中西部地区外商投资优势产业目录), which applies to foreign investment in the central and western regions, north-east regions, and Hainan Province.

Compared with the 2020 version, the Catalogue 2022 has 239 newly-added entries, among which the newly-added entries related to the pharmaceutical industry are partially listed below:

After a lengthy period of exploration by the State Administration for Market Regulation, Provisions for Supervision and Administration of Online Drug Sales (药品网络销售监督管理办法) ("Provisions for Online Drug Sales") came into force on December 1, 2022. As the departmental rule specifically regulates online drug sales, its implementation provides guidance on how to carry out online drug sales in compliance in China.

1.What entities can carry out online drug sales in China?

According to the Provisions for Online Drug Sales, entities entitled to engage in online drug sales include[8]:

2.Which kinds of drugs are prohibited from being sold online?

In China, not all drugs can be sold online. According to the Provisions for Online Drug Sales, vaccines, blood products, narcotics, psychotropic substances, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals and other drugs under special management by the country are prohibited from being sold online. The specific catalogue of such drugs is formulated by the NMPA. On November 30, 2022, the NMPA issued the List of Drugs Prohibited from Selling Online (the First Edition) (药品网络销售禁止清单（第一版）), implementing a "negative list" for the administration of drugs sold online. 

3.What special regulatory requirements are imposed on selling prescription drugs online?

The Provisions for Online Drug Sales expressly permit selling of prescription drugs online at the departmental rule level for the first time, and set out compliance requirements for selling of prescription drugs online, specifically:

The outbreak of COVID-19 has accelerated the development of "Internet Plus" medical services, an emerging business model combining information technology with traditional healthcare industries. Statistics from the PRC National Health Commission show that by the end of 2021, the number of China's online medical users reached 298 million, a surge of 83.08 million from 2020, accounting for 28.9% of the total number of Internet users. With more patients and users becoming aware of online medical treatment, the market for Internet-based medical services will continue to expand steadily.

On July 17, 2018, the PRC National Health Commission, together with the National Administration of Traditional Chinese Medicine, formulated the Administrative Measures for Internet-Based Diagnosis (for Trial Implementation) (互联网诊疗管理办法（试行）), the Administrative Measures for Internet Hospitals (for Trial Implementation) (互联网医院管理办法（试行）) and the Good Practices for Telemedicine Services (for Trial Implementation) (远程医疗服务管理规范（试行）), establishing a basic legal framework for China's Internet-based medical services sector. On February 8, 2022, the Detailed Regulatory Rules for Internet-Based Diagnosis (Trial) (互联网诊疗监管细则（试行）) ("Detailed Regulatory Rules") was issued, further elaborating on the regulations on Internet-based medical services. The Detailed Regulatory Rules specify that the basic principle for the regulation of Internet-based diagnosis is to carry out online and offline regulation in an integrated manner with localized supervision as the main task, offline medical institutions as the basis and information technologies as the support. The Detailed Regulatory Rules also highlight the core position of offline medical institutions in the Internet-based diagnosis, and the regulatory requirement that the Internet-based diagnosis services should be of the same quality as those provided by offline medical institutions.

1.What are the operation models of Internet hospitals in China?

According to Administrative Measures for Internet Hospitals (for Trial Implementation), Internet hospitals currently have two main operation models: (1) an independent Internet hospital affiliated to an offline medical institution set up by a third-party institution (usually an Internet information technology company, a medicaldevice company, etc.), and (2) an associated Internet hospital under an offline medical institution. The second model is divided into two sub-modes: (1) an associated Internet hospital independently set up by an offline medical institution, and (2) an associated Internet hospital jointly set up by an offline medical institution and a third-party institution.

2.Are there restrictions on foreign investment in Internet hospitals in China?

According to the Special Administrative Measures (Negative List) for Foreign Investment Access (Edition 2021) (外商投资准入特别管理措施（负面清单）（2021年版）) and the Interim Measures for the Administration of Sino-Foreign Equity and Cooperative Joint Venture Medical Institutions (中外合资、合作医疗机构管理暂行办法), only Sino-foreign joint venture medical institutions are allowed in China, and the equity or interests owned by the foreign investors must be capped at 70%. However, in practice, the above restrictions may be disapplied in certain parts of China and to certain kinds of investors. For example, (1) in a Sino-foreign joint venture medical institution established in Sichuan province, the foreign investor's equity interest is capped at 90% (instead of 70%)[10]; (2) service providers from Hong Kong SAR, Macao SAR and Chinese Taiwan may establish wholly-owned medical institutions in Chinese mainland[11]; and (3) foreign medical institutions may establish wholly foreign-owned medical institutions in the China (Shanghai) Pilot Free Trade Zone upon approval by relevant authorities[12].

On June 27, 2022, the Department of Comprehensive Affairs of the NMPA issued the Notice of the Department of Comprehensive Affairs of the National Medical Products Administration on Further Strengthening Services Provided to Foreign Invested Enterprises (关于进一步加强外资企业服务工作的通知) (the "Notice"), which supports Hong Kong and Macao drug MAHs and medical device registrants (collectively, the "Hong Kong and Macao MAHs") to manufacture their drugs and medical devices by qualified enterprises incorporated in the nine mainland cities of the Greater Bay Area (Guangzhou, Shenzhen, Zhuhai, Foshan, Huizhou, Dongguan, Zhongshan, Jiangmen and Zhaoqing in Guangdong Province).

On June 29, 2022, two days after the issuance of the Notice, the Department of Comprehensive Affairs of the NMPA issued the Implementation Plan for Supporting Hong Kong and Macao Drug Marketing Authorization Holders to Produce Drugs in the Nine Mainland Cities of the Greater Bay Area (支持港澳药品上市许可持有人在大湾区内地9市生产药品实施方案) and the Implementation Plan for Supporting Hong Kong and Macao Medical Device Registrants to Produce Medical Devices in the Nine Mainland Cities of the Greater Bay Area (支持港澳医疗器械注册人在大湾区内地9市生产医疗器械实施方案) (collectively the "Implementation Plans"). The Implementation Plans clarified the scope of application, entrustment procedures, application procedures, documentary requirements, etc., for Hong Kong and Macao MAHs to entrust the manufacture of drugs or medical devices in the nine mainland cities of the Greater Bay Area. The specific plans for entrusting the manufacture of drugs and medical devices by Hong Kong and Macao MAHs across the border have finally been implemented.

The Drug Administration Law newly revised in 2019 and the Regulations on the Supervision and Administration of Medical Devices newly revised in 2021 do not explicitly prohibit manufacture entrustment across the border. However, prior to the issuance of the Implementation Plans, pursuant to the Administrative Measures for Changes after Drug Marketing (for Trial Implementation) (药品上市后变更管理办法（试行）) and the Announcement of National Medical Products Administration on Matters Concerning the Manufacturing of Imported Medical Devices by Enterprises within the Territory of China (国家药监局关于进口医疗器械产品在中国境内企业生产有关事项的公告), if a drug MAH and medical device registrant outside Chinese mainland intend to manufacture drugs or medical devices that have been registered as imported drugs or imported medical devices in Chinese mainland, such drug or medical device shall first be registered as a domestic drug or medical device in Chinese mainland before it can be domestically produced.

The Implementation Plans removed such restrictions to a certain extent. Except for drugs and medical devices explicitly prohibited from being manufactured by entrustment under the Implementation Plans, Hong Kong or Macao MAHs which have obtained imported drug/medical device registration certificates for the Chinese patent medicines, chemical medicines and medical devices, may entrust enterprises with corresponding manufacturing qualifications and registered addresses and manufacturing sites located in the nine mainland cities of the Greater Bay Area to manufacture the registered Chinese patent medicines, chemical medicines and medical devices.

China attaches great importance to the development of the healthcare and pharmaceutical industries, encourages foreign investment in the healthcare and pharmaceutical industries, and continuously improves the investment environment in many aspects, such as innovating regulatory methods, speeding up review and approval, expanding market opening, and promoting the transformation of international rules. As opportunities and challenges are concurrent, China's healthcare and pharmaceutical industries will be subject to more comprehensive, detailed and stricter supervision with Chinese characteristics. For the enterprise interested in investing in China, it is strongly advised to engage a PRC law firm with rich experience in the healthcare and pharmaceutical industry to ensure full compliance in the investment, operation, exist and other aspects in order to secure ideal investment returns.

*Any reference to "Hong Kong" or "Hong Kong SAR" and "Macao" or "Macao SAR" shall be construed as a reference to "Hong Kong Special Administrative Region of the People's Republic of China" and "Macao Special Administrative Region of the People's Republic of China".

我国医药行业近年来不断出台各类鼓励政策，优化外商投资环境，在市场和政策的双重激励下，我国医药行业得到快速发展。2022年中国区医药交易活跃度居于世界前列，交易总金额达到346亿美元，同比增长10%[13]。

本文梳理了我国医药行业近年来值得关注的新规新政，并将主要围绕如下五点展开介绍：（1）中国药品、医疗器械监管制度改革；（2）《鼓励外商投资产业目录》增加医药产业条目；（3）药品网络销售新规出台；（4）互联网医院监管政策落地实施；以及（5）允许港澳MAH（见下文定义）跨境委托生产。

中国国务院于2015年8月发布的《关于改革药品医疗器械审评审批制度的意见》拉开了药品和医疗器械管理制度改革的帷幕。中共中央办公厅、国务院办公厅进一步于2017年10月发布《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》，中国的医药监管制度改革进入加速阶段。

与此相呼应，中国国家药品监督管理局（“NMPA”）于2017年加入国际人用药品注册技术协调会（International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use，“ICH”）、并于2018年当选为ICH管委会成员，中国药品注册管理制度加速与国际接轨。

在2016年发布的《药品上市许可持有人制度试点方案》（“《试点方案》”）实施之前，中国实行上市许可与生产许可绑定的药品/医疗器械管理模式，即只有具备药品/医疗器械生产能力的企业方可申请取得药品/医疗器械的上市许可。《试点方案》出台后，中国在北京、上海、广东等10个省市试点推行上市许可与生产许可相分离的新药品上市许可持有人制度（“MAH制度”）。而2019年12月1日施行的新《中华人民共和国药品管理法》（“《药品管理法》”），正式将MAH制度确立为在中国全国通行的药品管理制度。

在MAH制度下，不具备生产能力的企业或药品研制机构亦可以成为药品上市许可持有人（“MAH”），除法律明确规定不得委托生产的药品外[14]，MAH可以委托有资质的企业生产药品，但MAH仍需要对药品的非临床研究、临床试验、生产经营、上市后研究、不良反应监测及报告与处理等承担责任[15]。

与药品MAH制度相类似，2021年6月1日施行的新《医疗器械监督管理条例》同样在全国范围内确立了上市许可与生产许可相分离的医疗器械注册人/备案人制度。不同的是，2019年新修订的《药品管理法》首次在法律层面上明确了药品上市许可的可转让性[16]，使得药品上市许可转让成为药品资产转让的新交易模式之一；但截至目前，在中国转让医疗器械的上市许可尚无明确的条文依据。

除药品和医疗器械监管领域的基本大法外，NMPA近年来陆续对《药品注册管理办法》《药品生产监督管理办法》《医疗器械注册与备案管理办法》《医疗器械生产监督管理办法》等配套规定进行了修订和完善，时至今日，中国药品、医疗器械的监管制度已发生深刻变革并进一步与国际接轨。

1. 外商投资《鼓励外商投资产业目录》中的产业可享受哪些优惠政策？

我国对外商投资的产业监管政策，不仅有禁止、限制类的“负面清单”，也有“鼓励目录”。作为中国重要的外商投资促进政策之一，外商在中国投资《鼓励外商投资产业目录》内的行业领域，主要可以享受的优惠政策包括如下三项[17]：

2. 最新版《鼓励外商投资产业目录》在医药领域有哪些变化？

最新版《鼓励外商投资产业目录》（“《鼓励目录（2022版）》”）由国家发展和改革委员会和商务部于2022年10月26日共同发布并于2023年1月1日起施行。《鼓励目录（2022版）》延续了2020年版的结构，由两大部分组成：一是《全国鼓励外商投资产业目录》，适用于全国；二是《中西部地区外商投资优势产业目录》，适用于中西部地区、东北地区以及海南省。

《鼓励目录（2022版）》与2020年版相比总条目增加了239条，其中医药领域新增的产业不完全列举如下：

经过国家市场监督管理总局的漫长探索并多方征求意见后，《药品网络销售监督管理办法》（“《药品网售办法》”）于2022年12月1日起施行，作为一部专门规制药品网络销售活动的部门规章，其落地为如何在中国合规开展药品网络销售活动指明了方向。

1. 哪些主体可以在中国开展网上售药活动？

根据《药品网售办法》的相关规定，有资格开展药品网络销售的主体包括以下几类[20]：

2. 哪些药品在中国禁止通过网络销售？

在中国，并非所有药品均可通过互联网进行销售，《药品网售办法》明确规定：疫苗、血液制品、麻醉药品、精神药品、医疗用毒性药品、放射性药品、药品类易制毒化学品等国家实行特殊管理的药品不得在网络上销售，具体目录由NMPA组织制定。对此，2022年11月30日NMPA正式发布了《药品网络销售禁止清单（第一版）》，对网售药品种实施“负面清单”管理。

3. 网售处方药有哪些特殊监管要求？

《药品网售办法》首次在部门规章层面明确允许通过网络销售处方药，同时明确规定了对网售处方药活动的合规监管要求，具体而言：

新冠疫情的爆发加速了“互联网+医疗服务”这一新兴业态的发展，国家卫健委统计的数据显示，截至2021年底，我国在线医疗用户规模达到2.98亿人，比2020年增长了8308万人，在线医疗用户占网民总数的28.9%。随着越来越多患者和用户开始了解互联网医疗，互联网医疗市场空间仍在稳步增大。

2018年7月17日，国家卫生健康委员会联合国家中医药管理局组织制定了《互联网诊疗管理办法（试行）》《互联网医院管理办法（试行）》《远程医疗服务管理规范（试行）》，构建了互联网医疗的监管框架；2022年2月8日，《互联网诊疗监管细则（试行）》（“《细则》”）出台，进一步对互联网医疗相关规定进行细化。《细则》明确了互联网诊疗监管的基本原则是以属地化监管为主线、以实体医疗机构为依托、以信息化为支撑开展线上线下一体化监管，强调了实体医疗机构在互联网诊疗中的核心位置以及与实体机构诊疗服务“同质化”的监管要求。

1. 中国的互联网医院有哪些模式？

根据《互联网医院管理办法（试行）》，目前互联网医院主要有两种设置模式：（1）第三方机构（通常为互联网信息技术公司、医疗器械公司）依托实体医疗机构独立设置的互联网医院，以及（2）作为实体医疗机构第二名称的互联网医院，其中第（2）种模式下又分为实体医疗机构独立设置的第二名称互联网医院以及第三方机构与实体医疗机构合作共建的第二名称互联网医院。

2. 外商投资中国的互联网医院是否有限制？

根据《外商投资准入特别管理措施（负面清单）（2021年版）》以及《中外合资、合作医疗机构管理暂行办法》，外商投资中国医疗机构仅限于中外合资形式，且外方所占股权比例或权益不得超过70%。但实践中由于地区差异以及投资主体差异，存在突破前述限制的可能，例如：（1）在四川省境内设立中外合资医疗机构，外方在该等医疗机构中所占的股权比例或权益不得超过90%（而非70%）[22]；（2）中国香港、澳门和台湾地区服务提供者可以在中国大陆地区设立独资医疗机构[23]；以及（3）外国医疗机构经中国政府主管部门批准可以在中国（上海）自由贸易试验区以独资形式设置的营利性医疗机构[24]。

2022年6月27日，国家药监局综合司发布《关于进一步加强外资企业服务工作的通知》（“《通知》”），支持港澳药品上市许可持有人、医疗器械注册人（合称“港澳MAH”）将持有的药品、医疗器械在粤港澳大湾区内地9市（广东省广州市、深圳市、珠海市、佛山市、惠州市、东莞市、中山市、江门市、肇庆市）符合条件的企业生产。

继《通知》发布后两天，2022年6月29日国家药监局综合司发布《支持港澳药品上市许可持有人在大湾区内地9市生产药品实施方案》和《支持港澳医疗器械注册人在大湾区内地9市生产医疗器械实施方案》（以下合称“《实施方案》”），明确了港澳MAH在大湾区内地9市委托生产药品、医疗器械的具体适用范围、工作程序、申报路径及资料要求等。港澳MAH跨境委托生产药品、医疗器械的具体实施方案落地。

虽然2019年新修订的《药品管理法》和2021年新修订的《医疗器械监督管理条例》并未明确禁止跨境委托生产，但根据《药品上市后变更管理办法（试行）》以及《国家药监局关于进口医疗器械产品在中国境内企业生产有关事项的公告》等规定，以往的监管口径是中国大陆以外地区的药品/医疗器械持证人，如拟在中国大陆生产已注册为进口药品或进口医疗器械的产品时，需要先将该进口产品在中国大陆重新申请注册为国产药品/医疗器械产品，之后方可在中国大陆生产。

因此，《实施方案》的出台在一定程度上突破了该等限制，即除《实施方案》中明确的禁止委托生产的药品/医疗器械产品外，对于由港澳MAH持有和生产的、已获得药品注册证/医疗器械注册证并在中国大陆注册上市的中成药、化药和医疗器械，可以委托注册地址和生产场地均在大湾区内地9市的、具备相应生产资质的企业生产该等已注册中成药、化药和医疗器械。

我国高度重视医药行业发展，鼓励外商投资医药领域，在创新监管方式、加快审评审批、扩大市场开放、推进国际规则转化等众多方面持续优化投资环境。机遇与挑战相伴相生，我国医药行业亦将受到更全面、细致、严格的监管，并具有中国特色。对于来华投资企业而言，聘请在医药行业有丰富经验的中国律所协助其把控投资、运营、退出等各个环节的合规风险，可以达到更佳的投资效果。

*本文对任何提及“香港”的表述应解释为“中华人民共和国香港特别行政区”；对任何提及“澳门”的表述应解释为“中华人民共和国澳门特别行政区”。

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封面图源：画作·林子豪