CHINA: An Introduction to Healthcare (PRC Firms)
Healthcare in China
Driving Global Expansion Through Innovation
The transaction market within the PRC healthcare industry is experiencing robust recovery in 2024, with pharmaceutical companies gaining global recognition for local innovation achievements and acceptance of clinical trial data. While the USA and EU continue to be mature markets, the Middle East is emerging as a promising frontier. In addition, PRC time-tested products are also finding their positions in emerging regions such as Southeast Asia and Latin America due to their accessibility. Simultaneously, PRC pharmaceutical companies are energetically exploring diverse globalisation strategies, including joint ventures, public-private BOT models, and NewCo structures with the collaboration and support of overseas capital, responding to localisation trends across international markets while driving sustainable growth.
Optimising the Business Environment for Foreign Investors
The PRC authorities have rolled out various favourable policies to expand market access for foreign investment and optimise fair competition. These include macro-level commitments to continued opening-up in the healthcare sector, as well as specific initiatives that allow foreign-invested enterprises to participate in the development and application of human stem cells, gene diagnostics, and treatment technologies within pilot zones, while restrictions on wholly foreign-owned hospitals have been lifted, leading to eased burdens, broadened overseas financing channels and enhanced cross-border collaboration.
Localised manufacturing of imported products has become a cornerstone of multinational pharmaceutical companies’ strategies in the PRC. Market authorisation applications for imported innovative drugs (including chemical and biological products) transferred to domestic manufacturing entities are eligible for streamlined approval processes. Similar support is being studied on the state legislative level for the localised manufacturing of imported medical devices, a move designed to enhance industrial opening-up, optimise the foreign investment environment, activate high-quality domestic production capacity, and improve drug and medical device accessibility.
Aligning Legislation with Industry Evolution
The PRC legislation authority is advancing legislation to strengthen both regulation and development in the healthcare industry. Substantive progress has been made in drafting first foundational law on medical device regulation in the PRC, providing targeted support to medical device innovation with favourable policy support such as permitting transfer of marketing approvals, intensifying responsibility of local deputy of imported device, and establishing a vigilance system to align with international prevailing practices. These reforms aim to invigorate the medical device industry and optimise resource allocation.
In parallel, the PRC is refining its outbound data transfer regulations to ensure data security and privacy protection while facilitating cross-border data flows. Building on existing mechanisms – such as security assessments, standard contract filing, and certification for personal information protection – PRC cyberspace administration authorities newly issued regulations and supporting guidelines to provide exemptions for certain cross-border data transfer scenarios. This evolving mechanism reflects the government’s efforts to balance data security with reduced burdens, fostering an environment conducive to cross-border data flows.
Fostering Fair Competition through a Compliant Business Environment
In 2024, legislative improvement and intensification of enforcement are driving the optimisation of a compliant business environment. Relevant regulations and policies have been optimised pertaining to commercial bribery, corporate internal corruption, pharmaceutical procurement and sales, and medical insurance fund management, etc, with further clarification on the legal applicability and punishment standards for violations. With cross-departmental enforcement collaboration, initiatives such as industry irregularities rectification, unannounced inspection, and intensified internal reporting mechanism further enhanced regulatory effectiveness. Authorities maintain a continuous focus on comprehensive governance across the industry’s entirety and throughout its entire chain of operations, which provides clearer compliance guidelines, promotes market competition, and injects vitality into business environment.
To regulate market order and promote fair competition, the drafts of Anti-Monopoly Guidelines for the Pharmaceutical Sector and the Compliance Guidelines for Pharmaceutical Companies on Preventing Commercial Bribery Risks were issued by the market regulation authorities for public comments. The former provides clearer guidance for anti-monopoly enforcement and compliance by operators in the pharmaceutical industry by addressing prominent monopoly issues, elaborating on the manifestations of monopolistic conducts, enforcement principles, and criteria for determination. The latter, as the first set of nationwide compliance guidelines targeting the prevention of commercial bribery in the healthcare industry, offers practical guidance for the establishment of corporate compliance systems, as well as for identifying, preventing, and managing compliance risks related to commercial bribery.
Furthermore, industry associations also respond to compliance regulatory requirements to promote the orderly development of digital healthcare by issuing compliance guidelines, which for the first time, provides guidance for interactions between pharmaceutical companies and patients/patient organisations within digital interaction scenarios, thereby offering valuable practical reference.
Encouraging and Empowering In-depth Pharmaceutical Innovation
The PRC government is implementing comprehensive supporting measures for the development of pharmaceutical innovation, with multiple local governments releasing policies to support the high-quality development of innovative pharmaceuticals. The National Medical Products Administration (NMPA) has made efforts to improve the efficiency of clinical trial approvals to accelerate the research and development process for innovative pharmaceuticals. Furthermore, significant emphasis has been placed on “transformation mechanism of scientific and technological achievements” and “reform of empowering employee-invented technologies”. Certain key municipalities are further proposing support for the foreign-invested R&D centers.
Cell and gene therapy has emerged as an important “new playing field” in the innovative drug industry, with CAR-T (Chimeric Antigen Receptor T-cell) therapy serving as a quintessential example. The inherent quality risks and individualised nature of CAR-T cell therapy products make requisite strict oversight across their research, manufacturing, operation, and use. The NMPA and certain corresponding local authorities have both issued technical guidance principles and special rules in this field, to regulate the manufacturing, distribution, and quality management of CAR-T cell therapy products.
中国医疗健康领域概要指南
创新产品扬帆出海
2024年中国医药交易市场回暖趋势增强。一方面，中国药企本土创新成果及临床数据逐步获得国际药企及海外投资人认可，除了传统的美国、欧盟市场以外，中东市场崭露头角；中国药企的成熟产品因其药品可及性而在东南亚、拉美等新兴市场获得青睐。另一方面，中国药企也在积极探索出海的深度及新模式应对全球多国本地化趋势，包括企业和企业的合资企业、企业和当地政府合作的BOT模式、本土企业及海外资本合作的NewCo模式。
外资营商环境持续向好
中国监管部门发布一系列扩大外资市场准入、优化公平竞争环境的利好政策。不仅在宏观方向上强调持续推进医疗领域的扩大开放，还明确聚焦生物技术与独资医院领域的扩大开放试点工作，允许外商投资企业在试点区域内从事人体干细胞、基因诊断与治疗技术开发和技术应用，并放开设立外商独资医院的限制，从而进一步减轻外资企业负担，助力企业扩宽海外融资渠道，促进海内外医疗资源和经验的交流协作。
“地产化”已成为诸多跨国药企战略部署的重要一步，目前进口原研药（包括化学药品和生物制品）转移至境内生产的上市注册申请已纳入现行药品优先审评审批适用范围，进口医疗器械产品在中国境内企业生产事项也已进一步征求意见，旨在深入推进产业对外开放水平，优化外商投资环境、激活境内优质产能、促进医药行业高质量发展、提高药品及器械可及性。
立法工作进一步契合行业发展
在加强监管与促进发展并举的背景下，我国首部对医疗器械监管的基本法的立法工作有了实质性进展，对创新医疗器械提供利好的政策性支持，此外允许注册证转让、强化境内代理责任、建立医疗器械警戒制度等，进一步体现与国际通行规则对接的趋势。这将有助于激发医疗器械领域市场主体活力，优化市场资源配置。
为进一步保障数据安全，保护个人信息主体权益，促进数据依法有序自由流动，在既有的数据出境安全评估、个人信息出境标准合同备案和个人信息保护认证的数据出境三大路径的基础上，互联网信息监管部门通过规范数据跨境流动相关规定及其配套文件，进一步为部分数据出境情形提供了监管流程方面的豁免。这一动态调整既符合实践发展需求，推动了对中国数据出境监管体系的发展，又在降低潜在数据安全风险与减轻企业负担之间实现了平衡。
合规营商环境的有序性促进公平竞争
2024年进一步聚焦关键领域，通过立法完善与执法深化，推动合规营商环境实现优化。在商业贿赂、企业内部腐败、医药购销和医保基金管理等领域，优化相关法规政策、明确违规行为的法律适用和处罚标准；相关执法行动精准发力，加强医疗监督跨部门执法联动工作，通过行业乱象整治活动、飞行检查高风险领域、强化内部举报机制等，进一步提升监管效能。其中，监管机构持续聚焦医药领域生产、供销和使用等重点环节，对医药行业全领域、全链条、全覆盖系统治理。该等措施不仅为企业提供了更明晰化的合规指引，还能促进市场竞争秩序规范化，为营商环境的有序发展注入活力。
为进一步规范市场秩序，营造诚实守信、公平竞争的市场环境，市场监督管理部门先后就药品领域反垄断指南和医药企业防范商业贿赂风险合规指引征求意见。前者针对药品领域突出垄断问题，进一步细化垄断行为在药品领域的行为表现、执法原则和认定标准、为药品领域反垄断执法和经营者合规提供更为明晰的指引；后者作为首个针对医疗行业防范商业贿赂的全国性合规指引，为企业合规体系建设，识别、预防、应对在商业贿赂方面的合规风险提供具有操作性的指导。
进一步的，行业协会积极响应合规监管要求，为推动数字医疗有序发展，发布了数字医疗合规分项指南，在数字化互动场景下，首次针对医药企业与患者及患者组织的互动提出行为指引，对企业业务开展具有现实参考价值。
鼓励、赋能创新医药的纵深推进
国务院在政府工作报告中首次提及“创新药”，并落实全链条支持创新药发展，全国多地陆续响应，发布支持创新药高质量发展政策。此外，国家药品监督管理局出台试点方案提升临床试验审批效能，加速创新药研发进程。为深化医药卫生体制改革、科技体制改革，国家高度重视“深化科技成果转化机制”“深化职务科技成果赋权改革”全国推进，部分典型地区进一步提出支持外资研发中心落地发展并融入创新体系。
细胞与基因治疗已发展成为创新药领域重要“新赛道”，以CAR-T（嵌合抗原受体 T 细胞）为典型代表的细胞治疗产品因其质量风险大、个体定制化等特点，其研发、生产、经营、使用等环节均需要严格管控，国家药品监督管理局发布多项细胞与基因治疗领域技术指导原则，地方相关部门也相继出台专项监管规定，对规范CAR-T细胞治疗药品生产流通和质量管理发挥了重要作用。