Analysis Of China's New Draft Of Drug Regulatory Data Protection Rule: A New Perspective On Innovative Drug Transactions
2025年3月19日，国家药监局综合司发布了《药品试验数据保护实施办法（试行，征求意见稿）》和《药品试验数据保护工作程序（征求意见稿）》（合称"《征求意见稿》"）。作为与专利链接制度并行的、保护药品创新性的重要手段，药品试验数据保护制度一旦切实落地，将对新药上市以及药品许可交易产生重要影响。本文拟对药品试验数据保护制度及其影响作简要分析，供业界参考。
On March 19, 2025, the Comprehensive Department of the National Medical Products Administration released the Measures for the Implementation of Drug Regulatory Data Protection (Trial, Draft for Comments) and the Procedures for Drug Regulatory Data Protection (Draft for Comments) (collectively referred to as the "Draft for Comments"). As an important mechanism for promoting pharmaceutical innovation, the drug regulatory data protection system, operating in parallel with the patent linkage system, is expected to have a significant impact on the marketing of New Drugs and drug licensing transactions once effectively implemented. This article provides a brief analysis of the drug regulatory data protection system and its implications for pharmaceutical industry.
一、我国药品试验数据保护制度
Drug Regulatory Data Protection System in China
（一）背景与介绍
Background and Introduction
药品试验数据保护（Regulatory Data Protection，简称"RDP"）是指含有新型化学成份的药品以及《征求意见稿》规定的其他药品（合称"新药"）获批上市时，国家药监局对申请人提交的自行取得且未公开的试验数据和其他数据提供保护，其他申请人未经同意，不得依赖这些数据申请药品上市许可或补充申请的制度安排（简称"RDP制度"）。
Drug regulatory data protection (the "RDP") refers to the protection granted by the National Medical Products Administration (the "NMPA") over trial data and other data submitted by applicants that were independently obtained and not publicly disclosed at the time of marketing approval for new chemical entities or other pharmaceuticals specified in the Draft for Comments (collectively referred to as the "New Drugs"). Without the consent of the original applicant, other applicants may not rely on these data to seek marketing authorization or supplementary applications (referred to as the "RDP system").
早在2002年，国务院发布的《药品管理法实施条例》中就已经对中国的RDP制度进行了原则性规定，该规定一直延续到现行有效的《药品管理法实施条例》中。但是由于长期缺乏操作细则，该制度一直未能得到落实；在2018年，国家药监局发布《药品试验数据保护实施办法（暂行）（征求意见稿）》并征求意见，规定了RDP制度落地的若干细则规定，但是其后并未正式生效。2025年，国家药监局发布了新《征求意见稿》，对RDP制度进行了进一步调整和完善。2025年版《征求意见稿》的更新主要体现在以下几个方面：
As early as 2002, the Regulations for the Implementation of the Drug Administration Law (2002) issued by the State Council established general provisions for China's RDP system, which have been retained in the current effective Regulations for the Implementation of the Drug Administration Law (2024). However, due to the long-standing absence of detailed operational rules, the system had not been fully implemented. In 2018, the NMPA released the Measures for the Implementation of Drug Regulatory Data Protection (Provisional) (Draft for Comments), setting out more detailed provisions for the practical implementation of the RDP system, though it was never formally enacted. In 2025, the NMPA issued a new Draft for Comments, further refining and improving the RDP system. The key updates in the 2025 version are summarized as follows:
- 保护对象：不仅包括创新药和改良型新药，还明确包括首仿药，且三者均包括化学药品和生物制品，有助于更好地实现仿创平衡。
- Protected subjects: in addition to innovative drugs and improved new drugs, the scope of protection extends to first generic drugs, with all three categories covering chemical drugs and biological products, contributing to a more balanced approach between encouraging innovation and promoting generics.
- 保护期限：将创新药的保护期统一调整为六年，并对改良型新药和首仿药分别给予三年保护期；对于"境外已上市但境内未上市药品"，引入了"六年/三年减去境外首次上市与国内受理时间差"的保护期计算方式，旨在鼓励药品尽早在中国注册上市。
- Protection period: the protection period for innovative drugs is uniformly set at six years, with improved new drugs and first generic drugs each receiving three years of protection; for drugs already marketed overseas but not yet approved in China ("drugs marketed overseas but not yet marketed domestically"), a time-differential-based calculation method has been introduced: the protection period is calculated as six years (for innovative drugs) or three years (for improved new drugs) minus the interval between the date of first overseas marketing approval and the date of domestic application acceptance, which aims to incentivize earlier registration and market entry of drugs in China.
- 保护机制：在数据保护期内不批准尚未上市的（其他）仿制药的上市申请（除非适用《征求意见稿》中的例外情形），但在保护期届满前一年开放受理相关申请，以稳定企业预期。
- Protection mechanism: during the data protection period, marketing applications for (other) generic drugs that have not yet been marketed will not be approved (unless exceptions specified in the Draft for Comments apply). However, to provide predictability for industry stakeholders, such applications may be accepted within one year before the expiration of the protection period.
（二）RDP与专利链接制度
RDP and Patent Linkage System
为鼓励新药研发并推动高水平仿制药发展，我国近年来建立了具有中国特色的药品专利链接制度。该制度通过衔接仿制药上市审评审批程序与相关药品专利纠纷解决程序，旨在注册阶段早期解决专利纠纷。RDP制度的最终落地，能够在一定程度上与传统专利链接制度相配合，共同保护药品的创新性，并增强仿制药上市的可预期性。
To encourage new drug research and development and promote the advancement of high-quality generic drugs, China has established a unique drug patent linkage system in recent years. This system aims to address patent disputes at an early stage of the drug registration process by linking the review and approval of generic drug with the resolution of related patent conflicts. The final implementation of the RDP system is expected to complement the traditional patent linkage system, jointly protecting drug innovation while enhancing the predictability of generic drug market entry.
首先，二者的适用对象不同。专利链接制度主要针对已在中国上市药品专利信息登记平台登记相关专利信息的专利权，并为药企的知识产权保护和药品专利纠纷的早期解决提供有效平台。RDP制度则主要用于保护试验数据和其他数据，从而使被保护药品获得更多的市场空间。二者并行适用，共同构筑了药品创新保护制度体系。
First, the two systems have different applicable subjects. The patent linkage system primarily applies to patents registered on the China Marketed Drug Patent Information Registration Platform, providing an effective platform for pharmaceutical companies to protect intellectual property and to resolve drug patent disputes at an early stage. In contrast, the RDP system focuses on the protection of trial data and other data, thereby securing a period of market exclusivity for New Drugs. These two systems jointly establish a comprehensive framework for protecting pharmaceutical innovation.
其次，二者在效果方面互补。专利链接制度的实施基于有效的专利权，而该等专利权可能受限于过期或其他可能使其无效的司法程序或行政裁决，从而影响专利链接制度的可行性和实际效果。此外，因专利链接制度所提起的司法程序和行政裁决存在耗时长、成本高昂等特点，也可能对已上市药品的商业化产生较大影响。RDP制度能够在一定程度上弥补该等局限。举例来说，RDP是由国家药监局根据上市药品的注册分类直接授予，该等保护无需通过任何司法程序或行政裁决即可获得，可以更稳定地延缓（其他）仿制药的上市进程，从而有助于提升药品市场收益的稳定性和可预期性。
Second, the two systems are complementary in terms of effectiveness. The implementation of the patent linkage system is based on valid patent rights, which may be subject to expiration or judicial proceedings or administrative rulings that could result in invalidation or expiration, thereby affecting the feasibility and practical effectiveness of the patent linkage system. Moreover, the judicial and administrative processes under the patent linkage system can be lengthy and costly, potentially impacting the commercialization of marketed drugs. In this regard, the RDP system can serve as a valuable complement. For example, RDP is directly granted by the NMPA based on the registration classification of marketed drugs, and such protection can be obtained without any judicial proceedings or administrative rulings, allowing for a more predictable and stable delay in the marketing of other generic drugs, thereby enhancing the stability and predictability of market returns.
但需要注意的是，专利链接制度与RDP制度如何协调运行，仍有待监管部门进一步明确。例如，如果《征求意见稿》以其现有文本正式生效，专利链接程序（例如专利权人提起的司法程序和行政裁决）是否必须等到试验数据保护期届满前一年方可启动？这一点仍有待进一步厘清。
However, questions remain regarding the harmonization and practical implementation of the patent linkage system and the RDP system. For instance, if the current text of the Draft for Comments is finalized, it is still unclear whether patent linkage procedures (such as judicial proceedings or administrative rulings initiated by patent holders) shall await the final year of the data protection period before being initiated.
二、2025《征求意见稿》对许可交易的启发
2025 Draft for Comments: Implications for Licensing Transactions
对于许可方和被许可方而言，理解RDP制度对许可交易的潜在影响，并提前布局交易安排，将有助于更好地把握风险与收益，实现交易价值的最大化。基于此，我们拟从条款设计和交易策略两个维度，探讨《征求意见稿》对许可交易的具体启示：
For both licensors and licensees, understanding the potential impact of the RDP system on licensing transactions and proactively structuring deal arrangements are essential to effectively manage risks and optimize returns. To this end, this section explores the implications of the Draft for Comments on licensing agreements focusing on two key areas: contractual clause design and transactional strategy:
（一）在条款设计方面
From the perspective of contractual clause design
01 监管独占期
01 Regulatory Exclusivity
特许权使用费期限（Royalty Term）与许可协议的期限（Term）密切相关，且通常以下列三个节点较早/晚者确定：（1）许可产品的最后一项有效权利要求到期（Last Valid Claim）；（2）首次商业化销售（First Commercial Sale）之日起一定时间；（3）所有监管独占期到期。在既往的大陆许可交易实践中，尽管监管独占期（例如RDP）常被写入协议，但由于RDP制度未实际落地，该条作用通常相对有限。
The royalty term is closely related to the term of the license agreement and is typically determined by the earliest or latest of the following three events: (1) the expiration of the last-to-expire patent right (Last Valid Claim); (2) a certain period after the first commercial sale of the licensed product; and (3) the expiration of all Regulatory Exclusivity. In past drug licensing transactions in Chinese mainland, although Regulatory Exclusivity (such as RDP) was often incorporated into agreements, its practical effect was usually limited, as the RDP system had not yet been implemented.
若《征求意见稿》能最终落地，相关条款未来有望产生切实的影响，能够给许可方带来巨大的商业利益。特别是在约定特许权使用费期限于三个节点较晚者届满，且专利保护期届满但RDP还有效的情况下，需要许可交易双方根据商业安排予以评估。从许可方的角度，RDP制度的落地将潜在延长特许权使用费期限，以收取更多特许权使用费，因此许可方需要尽可能将监管独占期纳入期限计算的考量因素；而从被许可方的角度，为了减少监管独占期的影响，可争取约定上述三个时间点较早者为特许权使用费期限届满日。
If the Draft for Comments is eventually implemented, the relevant provisions are expected to have practical impact in the future and could generate significant commercial benefits for licensors. In particular, when the royalty term is set to expire at the latest of the aforementioned three specified events, and the patent protection period has expired but the RDP remains in effect, both parties of the licensing transaction shall assess such scenario based on their commercial arrangements. From the licensor's perspective, the implementation of the RDP system could potentially extend the royalty term, allowing for higher royalty payments; thus, the licensor should seek to include the Regulatory Exclusivity as a factor in calculating the royalty term. From the licensee's perspective, to mitigate the impact of the Regulatory Exclusivity, it may seek to set the earliest of the three specified events as the end date of the royalty term.
除此以外，监管独占期还可能影响特许权使用费的调整。通常在许可交易中，特许权使用费可能因特定原因予以调减，例如专利有效期（Valid Claim）的届满、仿制药（Generic Version）上市等。许可交易双方需要对仿制药上市的可能时点和特许权使用费产生的商业效果进行进一步讨论。
In addition, the Regulatory Exclusivity may also affect royalty adjustments. In licensing transactions, royalties are typically subject to reduction for certain circumstances, such as the expiration of the Last Valid Claim or the market entry of a generic drug. As a result, both parties of a licensing transaction should carefully assess the potential timing of generic entry and its commercial impact on royalty payments.
02 药品开发上市计划
02 Drug Development and Market Entry Plan
同一种许可产品在不同区域上市的先后顺序，往往影响着许可产品可在大陆申请的不同注册类型。而根据当前的《征求意见稿》，不同注册类型的药品各自对应不同的RDP期限，这就要求许可方和被许可方将RDP制度的商业影响纳入考量，并就许可产品在全球的上市计划达成共识。
The sequence in which the same licensed product is marketed in different regions often affects its applicable registration classification in Chinese mainland. According to the current Draft for Comments, different registration categories are associated with varying RDP periods, which requires both the licensor and licensee to take into account the commercial implications of the RDP system and align on a coordinated global market entry strategy for the licensed product
例如，对化学药品交易的被许可方而言，如果计划让许可产品在中国取得1类创新药的地位（获得6年RDP），则其应当与许可方沟通上市计划，要求许可方不得在被许可方提交中国境内NDA之前获得美国或其他司法辖区的NDA批准，以确保被许可方达成在中国取得1类创新药地位的目标。此外，如果被许可方拟让许可产品作为5.1类化学药品进行申报，则需要与许可方沟通许可产品境内外上市的时间差。原因是，就5.1类化学药品而言，RDP期限取决于境内受理时间与境外首次上市的时间差，如果境外过早上市，而境内提交上市申请时间过于滞后，则许可产品将无法获得较长的RDP期限。
For example, in the case of a chemical drug transaction, if the licensee intends for the licensed product to qualify as a Class 1 innovative drug (eligible for a 6-year RDP period) in China, it should coordinate with the licensor on the global development and marketing timeline to ensure that the licensor does not obtain NDA approval in the United States (or in other jurisdictions) before the licensee submits the NDA in China, a critical step in securing the Class 1 innovative drug status in China. Alternatively, if the licensee intends to register the licensed product as a Class 5.1 chemical drug, it is advisable to align with the licensor on the timing of domestic and overseas market entry. For Class 5.1 chemical drugs, the RDP period is determined by the length of interval between the date of first overseas marketing approval and the date of domestic application acceptance; if the product is marketed overseas too early and the Chinese NDA submission is significantly delayed, the licensed product may fail to qualify for an adequate RDP period.
03 各方的勤勉义务与责任
03 Diligence Obligations and Responsibilities of the Parties
考虑到RDP制度的商业影响和实际落地情况，能否取得某类注册地位（例如3类和5.2类下的首仿药），往往需要遵循监管所要求的严格时间安排以及程序要求。在这种情况下，许可协议双方及相关合作方（如CRO、CDMO等）可以在相关协议中就时间表、任务分工和勤勉义务做出明确约定，从而有助于各方形成一致预期，降低因执行节奏不一或责任不清而产生潜在争议的风险。
Given the commercial impact and practical implementation of the RDP system, obtaining a specific registration status (e.g., first generic drug under Class 3 or 5.2) often requires strict adherence to regulatory timelines and procedural requirements. In such cases, both parties and related collaborators (e.g., CROs, CDMOs) may clearly define timelines, task allocations, and diligence obligations in relevant agreements. This helps align expectations and reduce the risk of potential disputes arising from inconsistent timelines or unclear responsibilities.
例如，在许可交易双方之间，约定哪一方负责申请药品上市和RDP，由此产生的费用如何承担；在申请上市前和上市审评期间各方的权利义务以及合规保证；未获得RDP的各方责任等。此外，为使各方及时知晓RDP制度正式落地情况，还可约定某一方在确认RDP制度的可行性后，立即通知另一方，并提交至JxC就其申请策略进行讨论。
For example, between the licensor and licensee, the agreement may specify which party is responsible for applying for marketing approval and RDP, how associated costs will be borne, and the rights and obligations of all parties during the pre-marketing application and review period. It may also set out provision regarding liabilities in case RDP is not obtained. Additionally, to ensure timely awareness of the formal implementation of the RDP system, it may be agreed that one party shall immediately notify the other upon confirming the feasibility of the RDP and submit it to JxC for discussion on application strategy.
（二）在交易策略方面
From the perspective of transactional strategy
重新评估财务条款
01 Re-evaluate financial terms
若《征求意见稿》能够切实落地，原研药和部分仿制药的市场独占地位将在RDP制度下得到强化，从而影响药品定价和市场收益。具体而言，RDP制度可能产生延长新药市场独占期的效果，可能有助于提高许可产品上市后现金流的可预期性，在测算首付款、里程碑付款以及特许权使用费比例等条款时，许可交易双方可以将RDP制度的价值纳入考量，据此进一步调整首付款、里程碑付款和销售收入分成比例。
If the Draft for Comments is effectively implemented, the market exclusivity of brand-name drugs and certain generic drugs will be potentially prolonged under the RDP system, thereby affecting drug pricing and market revenue. Specifically, the extended market exclusivity period for New Drugs may enhance the predictability of cash flows after product marketing. As a result, the parties of a licensing transaction should factor the value of the RDP system into structuring financial terms, including upfront payments, milestone payments, and royalty rates, and adjust accordingly.
02 安排药品同步/尽早在中国上市
02 Schedule simultaneous/early marketing of drug in China
根据《征求意见稿》，对于境外已上市而境内未上市的药品，原则上境内外药品的上市时间差越短，在境内可享受的试验数据保护期可能越长。为此，原研药许可双方应早做部署，例如国内被许可方可以提前引进境外新药，国外许可方也可以尽早寻求中国合作方展开合作；从仿制药企的角度，亦可以加大研发力度，在境外上市的原研药在境内上市之前通过审批，以获得对应的RDP。
According to the Draft for Comments, for drugs marketed overseas but not yet marketed domestically, the shorter the interval between the date of first overseas marketing approval and the date of domestic application acceptance, the longer the potential data protection period available domestically. Therefore, brand-name drug licensors and licensees should consider early planning—for example, domestic licensees may seek to introduce brand-name drugs to the Chinese market at an earlier stage, while overseas licensors may aim to find Chinese partners as early as possible; from the perspective of generic drug companies, they may also accelerate R&D timelines to secure regulatory approval prior to the domestic marketing of the brand-name drug, thereby obtaining an adequate RDP.
03 发掘数据本身的交易价值
03 Exploring the transactional value of data
当前的《征求意见稿》并没有禁止其他申请者经权利人同意，而使用试验数据和其他数据，原研药企或首仿药企或可通过授权其他药企使用相关数据的方式获得收益，充分发挥数据的经济价值，提升药品收益潜力。关于许可试验数据的可行性有待监管机关进一步明确。
The Draft for Comments does not prohibit other applicants from using trial data and other data with the consent of the rights holder. As a result, brand-name drug companies or first generic drug companies may potentially generate revenue by authorizing other pharmaceutical companies to use the relevant data, thereby maximizing the economic value of such data and enhancing the revenue potential of the drug. However, the feasibility of licensing trial data remains subject to further clarification by the regulatory authorities.
总体而言，与2018年《药品试验数据保护实施办法（暂行）（征求意见稿）》相比，《征求意见稿》保护药品范围更加广泛，包括创新药、改良型新药、首仿药（三者均包括化学药品和生物制品），且对属于同一个批准文号的创新药的不同适应症，按照注册类别分别给予保护，不再单独区分适应症。这意味在进行未来交易设计和布局时，许可交易的双方可以从各自的角度，更加充分考虑RDP制度可能带来的潜在机会和有利影响。
Overall, compared to the Measures for the Implementation of Drug Regulatory Data Protection (Provisional) (Draft for Comments) (2018), the Draft for Comments expands the scope of protected pharmaceuticals to include innovative drugs, improved new drugs, and first generic drugs (all of which include chemical drugs and biological products). For different indications of an innovative drug under a single approval number, RDP can be granted according to the respective registration categories, without separate distinction for each indication. This means that when designing and structuring future transactions, parties of a licensing transaction can further consider, from their individual perspectives, the potential opportunities and favorable impacts arising from the RDP system.
三、未来展望
Outlook
目前，《药品管理法》尚未对临床试验数据保护作出规定，仅在《药品管理法实施条例》中有所体现。若《征求意见稿》正式实施，原研药企可充分利用RDP制度带来的优势，加强创新成果保护，制定更具前瞻性的中国市场策略；仿制药企也可把握RDP和首仿药市场独占期带来的机遇，合理规划申报与上市时机，探索与原研药企的合作机会。此次《征求意见稿》的出台，充分表明中国正稳步构建更加系统化的药品创新保护体系，我们相信，专利链接与RDP制度的协同推进，将有助于进一步完善平衡创新激励与仿制药发展的法律框架，并推动中国医药产业迈向更高质量发展。
At present, the Drug Administration Law does not contain provisions on RDP, which is only reflected in the Regulations for the Implementation of the Drug Administration Law. If the Draft for Comments is formally implemented, brand-name drug companies will be better positioned to leverage the RDP system to strengthen the protection of innovative products and formulate forward-looking market strategies for the China market. At the same time, generic drug companies can also benefit from the market exclusivity period offered by RDP system for first generic drugs to strategically plan their regulatory submission timelines, while exploring collaboration opportunities with brand-name drug companies. The release of this Draft for Comments signals that China is steadily establishing a more systematic framework for the protection of pharmaceutical innovation. We believe that the coordinated development of the patent linkage system and the RDP system will further refine the legal balance between innovation incentives and generic drug development, ultimately driving China's pharmaceutical industry toward higher-quality and sustainable growth.
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