Introduction

On 15 May 2026, the National Medical Products Administration (NMPA) officially promulgated the Implementation Measures for Protection of Drug Trial Data (the Implementation Measures) via Announcement No. 47 of 2026, which took effect on the same day. This marked the culmination of a legislative journey spanning more than two decades, transforming China’s drug trial data protection (also known as Regulatory Data Protection (RDP)) framework from a statutory principle into an enforceable operational regime. Concurrently, the NMPA issued the Working Procedures for Drug Trial Data Protection (the Working Procedures), establishing detailed procedural mechanisms for implementation. This article provides a comprehensive overview of China’s new drug trial data protection regime, analysing its scope, duration, procedural requirements and practical implications.

Legislative evolution: from principle to practice

The legislative history of China’s drug trial data protection regime can be divided into four phases: conceptual inception, renewed attempts, legislative reset and formal implementation.

Conceptual inception (2002–2016)

Article 35 of the Implementing Regulations of the Drug Administration Law first introduced data protection in 2002, meaning that the state would protect independently obtained and undisclosed trial data submitted by manufacturers or sellers of drugs containing new chemical entities. Within six years of marketing approval, the drug regulatory authority would not approve applications by other applicants using that data without the original applicant’s consent. This principle was carried forward and given more concrete procedural form in article 20 of the 2007 Drug Registration Measures, which specified a six-year protection period and reaffirmed the regulatory authority’s obligation to withhold approval for unauthorised use of protected data. However, for more than a decade, the drug regulatory authorities were unable to accept or process any data protection applications due to the absence of implementing rules, leaving the system effectively inoperative.

Renewed attempts (2017–2019)

In October 2017, the General Offices of the CPC Central Committee and the State Council issued the Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices, explicitly calling for “improving and implementing the drug trial data protection system”. In April 2018, the NMPA issued a draft Implementation Measures for Drug Trial Data Protection (Provisional), which outlined a preliminary systematic framework.

Legislative reset (2020–2025)

The phase one US–China Economic and Trade Agreement signed in January 2020 required both parties to provide effective protection for undisclosed trial data. At the same time, the Drug Registration Measures promulgated in July 2020 – a comprehensive revision of the 2007 version – did not retain the data protection provision that had previously been included. This omission was not a retreat but reflected a legislative realignment: as a substantive intellectual property right, data protection was considered more appropriately addressed in the Implementing Regulations of the Drug Administration Law rather than in a procedural regulation. The provision, which had remained largely inoperative due to the absence of implementing rules, was deferred pending the revision of the higher-level regulation, with a view to rebuilding the system on a firmer legal footing.

Formal implementation (2026)

On 16 January 2026, State Council Order No. 828 promulgated the revised Implementing Regulations of the Drug Administration Law, whose article 22 formally established the data protection regime. The Implementing Regulations took effect on 15 May 2026, on which date the NMPA issued the Implementation Measures for Protection of Drug Trial Data and Working Procedures for Protection of Drug Trial Data – marking the journey from principle to rule, and from text to practice.

Scope of protection
Protected subject matter

Article 3 of the Implementation Measures defines the protected subject matter as “trial data and other data submitted by applicants that have been independently obtained and not disclosed”. It further provides that, during the data protection period, the NMPA will not approve any applications submitted by other applicants that rely on such data without the consent of the marketing authorisation holder (MAH). The data protection period shall not exceed six years, calculated from the date on which the drug registration application is approved within the territory of China.

“Undisclosed”: with the development of the industry and the need to protect the public’s right to know, drug regulatory authorities in major countries and regions generally require the disclosure of clinical trial result summaries or reports. “Undisclosed” under the Implementation Measures means that the relevant trial data have not been fully disclosed. If only a part of the trial data has been disclosed, the trial data as a whole remain undisclosed.

“Independently obtained”: this includes drug trial data obtained by applicants through conducting research themselves, commissioning research or through purchase or obtaining exclusive authorisation.

“Reliance”: under normal circumstances, the marketing of a new drug requires the submission of complete pharmaceutical, non-clinical study and clinical trial data. Modified new drugs and generic drugs, however, use the marketed originator drug as a reference and generally do not need to repeat clinical trials. Instead, they adopt a comparative approach against the marketed originator drug to provide supplementary evidence of safety and efficacy that demonstrates clinical advantages, or use bioequivalence studies and other indirect methods to prove pharmaceutical consistency and therapeutic equivalence. “Reliance” under the Implementation Measures refers to the situation where other applicants, when applying for marketing authorisation, cite or refer to the trial data of the MAH that prove the drug’s safety and efficacy, without repeating the same trials.

Scope by drug classification

Innovative drugs (Class 1): article 5 provides that the scope of data protection for innovative drugs covers all trial data in the drug marketing authorisation application materials used to prove the safety, efficacy and quality controllability of the drug, with a protection period of six years from the date of first marketing approval in China. This encompasses pharmaceutical data (active pharmaceutical ingredient (API)/formulation research, manufacturing process, quality standards and methodological studies, stability studies, packaging material compatibility studies, etc), non-clinical study data (pharmacodynamic studies, pharmacokinetic studies, toxicological studies, safety pharmacological studies, etc) and clinical study data (early-phase clinical (Phase I/II) data, pivotal clinical (Phase III) data, etc).

Modified new drugs (Class 2): article 6 limits the scope of data protection for modified new drugs to new clinical trial data demonstrating obvious clinical advantages over drugs containing known active ingredients (marketed biological products), while excluding bioavailability, bioequivalence and immunogenicity data for vaccines, with a protection period of four years.

First generic drugs (chemical drugs Class 3 and Class 5.2 and biological products Class 3.2): article 8 provides that the scope covers necessary clinical trial data supporting approval, likewise excluding bioavailability, bioequivalence and vaccine immunogenicity data, with a protection period of three years.

Originator drugs marketed overseas applying for marketing approval in China (chemical drugs Class 5.1 and biological products Class 3.1): these receive a six-year protection period under article 5, with the same scope as Class 1 drugs.

Indication-level protection

Articles 5 and 7 establish a tiered protection mechanism for indications. For multiple indications successively approved for the same innovative drug under the same approval number, each indication receives data protection according to its registration class. For an originator drug marketed overseas applying for marketing approval in China, when a registration application is first filed for a new indication that has not been approved for marketing either within or outside China, supported by complete trial data, a six-year data protection period is granted. For subsequent added indications, a four-year protection period applies.

Key exclusions from protection

The following data types are excluded from trial data protection:

bioavailability and bioequivalence study data;
vaccine immunogenicity data; and
post-marketing clinical trial data generated under conditional approvals (these serve as supplementary evidence to earlier approval conclusions and do not constitute new data proving clinical safety and efficacy).

Key features of the 2026 regime

Significant extension of protection periods
Compared to the 2025 draft Implementation Measures, the final Implementation Measures substantially extended protection periods for several drug classes:

modified new drugs: protection period increased from three years to four years; and
originator drugs marketed overseas applying for marketing approval in China and modified drugs: the complex calculation formula deducting the time difference between overseas first approval and domestic application acceptance has been eliminated. These drugs now receive the full six-year and four-year protection periods respectively, without reduction.

The “global new indication” provision

Article 7 introduces a significant provision addressing a previously ambiguous area: for an originator drug marketed overseas but not in China, when the first application in China is for a new indication that has not been approved for marketing either within or outside China, the drug receives a six-year data protection period – the same as Class 1 innovative drugs – despite technically falling under Class 2.4 (modified new drug) in registration classification.

This provision addresses a critical gap in the earlier draft. Under the previous framework, if a drug already approved for a first indication overseas sought approval in China for the same indication as its first-ever entry into China, it would be treated as a Class 5.1 drug and receive six years of data protection (minus a time-based deduction). However, if the same drug – still never approved in China – sought approval in China for a globally new indication (ie, not yet approved anywhere in the world), it would technically fall under Class 2.4 (modified new drug) and receive only three years of data protection (also subject to deduction), under article 6.

This created a perverse outcome: in both scenarios, the drug was entering China for the first time and required the submission of a fully disclosed trial data, but the protection term differed significantly – not because of any difference in the data submitted, but purely because of the registration classification assigned based on the indication’s approval status abroad.

Article 7 corrects this by granting six years of data protection for an originator drug that is already marketed overseas but not in China, where its first application in China is for a new indication that has not been approved anywhere in the world – even though it technically falls under Class 2.4. This six-year term aligns with what Class 1 innovative drugs receive, reflecting the fact that the applicant has submitted a complete data package for the drug’s initial entry into China. For subsequent indications added after the drug is already on the Chinese market – which would not require a full data package – the shorter protection period under Class 2.4 would remain appropriate.

Simultaneous application and review process

Article 9 of the Implementation Measures provides that an applicant intending to apply for data protection shall simultaneously submit a data protection application when filing the drug marketing authorisation application. The Working Procedures further clarify the detailed process:

Formal review: upon accepting the marketing registration application, the Centre for Drug Evaluation (CDE) conducts a formal review of the data protection application and marks the product after acceptance.
Technical evaluation: during the technical evaluation, the CDE determines whether data protection should be granted and clarifies the period of protection.
Publication: for drugs granted data protection, the NMPA annotates data protection information in the drug approval certificate, and the CDE establishes a data protection column on its website to publish relevant information.

The “one-year window” rule

Article 12 of the Implementation Measures provides: after a drug obtains data protection, other applicants may submit drug marketing applications or supplementary applications relying on the protected data within one year before the expiration of the data protection period; the CDE shall suspend the review time after completing technical evaluation and approve the relevant drugs after the data protection period expires.

This provision allows generic applicants to file applications before the data protection period expires, with approval deferred until after the data protection period ends – analogous to the Bolar exemption in other jurisdictions.

Protection and exceptions
Rights during the protection period

During the data protection period, without the consent of the MAH, the NMPA shall not approve any marketing authorisation application or supplementary application submitted by other applicants that relies on the protected data. For the protected data of modified new drugs and first generic drugs, the scope of protection is limited to chemical generics and biosimilars that rely on such protected data. For protected data of innovative drugs and originator drugs marketed overseas applying for marketing approval in China, the scope of protection extends to modified new drugs, chemical generics and biosimilars.

Exceptions to protection

Independently obtained data: other applicants submitting drug registration applications with independently obtained data shall be approved if they meet the requirements, but shall not be granted a data protection period, and such data may not be relied upon by subsequent applicants.

Public interest: in the event of a public health emergency, or where public interest so requires, relevant provisions shall apply.

Early filing provision: generic manufacturers may file applications relying on protected data within one year before the data protection period expires, with approval deferred until the period ends.

Termination of data protection
Data protection shall terminate if:

the drug approval certificate is revoked, withdrawn or cancelled;
the MAH voluntarily waives data protection; and
other circumstances prescribed by laws and regulations.

Upon termination, the NMPA shall issue a notice and the CDE shall update the data protection column accordingly. From the date of the notice, the NMPA may accept or approve drug registration applications relying on the protected data.

Regulatory strategy and commercial planning

While the Implementation Measures establish a comprehensive framework for drug trial data protection, several interpretive issues have emerged in industry discussions that merit closer examination. These issues, though not explicitly addressed in the current regulatory text, have significant implications for regulatory strategy and commercial planning.

The scope of six-year data protection for Class 2.4 chemical drugs and its coverage of other salt forms
Under the Implementation Measures, a Class 2.4 chemical drug may obtain six-year data protection only in the special circumstance where the product is an originator drug marketed overseas that has not yet been approved in China, and the application first seeks approval of a globally new indication that has not previously been approved either in China or overseas, supported by a complete set of data demonstrating safety, efficacy and quality controllability. In such a case, the six-year data protection is essentially tied to the globally new indication, and its protection scope should extend to the active moiety and related forms, including the free acid/base and other salt forms.

By contrast, for a regular modified new drug, it would generally not qualify for the above-mentioned six-year data protection. Instead, it may only receive four-year data protection based on new clinical trial data demonstrating significant clinical advantages. The scope of such protection is much narrower: it only prevents generic applicants from relying on such protected clinical trial data. For example, a Class 2.1 chemical drug of a new salt would not block approvals of drugs containing other salt forms or the free acid/base forms, because those drugs would not rely on the Class 2.1 salt data, but rather on the data (if any) associated with the underlying Class 1 drug.

The extension of six-year data protection to the active moiety and related forms

Although there is no explicit provision directly addressing this issue, the regulatory framework suggests that the six-year data protection, regardless of being based on chemical drug Class 1, 2.4 or 5.1, would substantially cover the active moiety of the drug. This is because drugs containing optical isomers, esters, salts, modified acid radicals, bases, or metal elements of known active ingredients or other non-covalent derivatives, are classified as Class 2 chemical drugs and are generally considered to rely on Class 1 drugs under the data protection framework. Accordingly, the six-year data protection granted to a Class 1 drug (or a Class 2.4 or 5.1 drug) substantially extends to the active moiety and its related optical isomers, esters, salts, acid radicals, bases, metal elements and other non-covalent derivatives.

Multi-indication scenarios and the “umbrella effect”

The Implementation Measures establish a tiered protection mechanism for multiple indications successively approved for the same drug. The first indication for a Class 1 or Class 5.1 drug receives six-year protection, while subsequent added indications receive four-year protection. However, the interplay between these overlapping protection periods has significant practical implications.

Critically, once the six-year protection for the first indication remains valid, it continues to cover all subsequent supplementary indications (provided those supplementary indication applications are filed during the six-year term). In the scenario where a second indication receives only four-year data protection, after that four-year data protection expires, the six-year data protection of the first indication remains valid and continues to cover the second and further indications. This creates a practical “umbrella effect”: the six-year data protection of the first indication effectively extends protection over subsequent indications even after their own shorter protection periods have expired. Generic applicants must therefore track the expiration of the six-year data protection associated with the first indication, rather than the four-year data protection of subsequent indications, to determine when they may lawfully enter the market. The “one-year window” rule under article 12 allows generic applicants to file applications one year before the expiration of the data protection period, which, in this context, means one year before the six-year data protection expires.

Practical implications for industry
Impact on licensing and transactions

The Implementation Measures provide significant benefits for pharmaceutical companies and their licensing strategies.

Increased pipeline valuation: the data protection framework effectively mitigates the “patent cliff” impact by providing four to six years of data protection even if patents expire or are invalidated early. This enhances the valuation of innovative drug pipelines.

Extended royalty terms: the presence of an enforceable data protection period may extend royalty payment terms, as royalty terms in licensing agreements often extend until the latest of the last valid claim expiry, a specified period after first commercial sale and expiry of all regulatory exclusivities.

Commercialisation of reliance rights: data holders may commercialise the right to rely on protected data by permitting generic applicants to submit applications in advance of data protection period expiry.

Strategic considerations for new drug applications

First indication strategy: since the first indication for a Class 1 or Class 5.1 drug receives six-year protection while subsequent added indications receive only four years, companies should strategically consider which indication to file first in China to maximise protection.

Global new indication strategy: article 7 creates a significant incentive for global new indications in China – developing a new indication not yet approved anywhere in the world and filing it first in China can secure six-year protection. However, active ingredients already approved in China for any indication are ineligible for the six-year benefit for subsequent indications.

Production transfer: where an overseas-manufactured originator drug transfers production to China, the data protection period of the originator drug can be maintained. The domestic MAH must obtain the consent of the originator MAH.

Conclusion

The Implementation Measures, effective on 15 May 2026, mark a watershed moment in China’s pharmaceutical regulatory framework, transitioning the country’s data protection from an unenforceable principle to an operational system that provides up to six years of data protection for innovative drugs, modified new drugs in specific circumstances and first generics, while preserving access to affordable medicines through the one-year filing window and the independent data exception. Strategically, companies should reshape filing priorities – as indication sequencing affects protection length and the global new indication provision offers a valuable option – revalue licensing transactions given the predictability of exclusivity rights and closely track data protection status for generic market entry. Overall, for companies operating in or entering China, understanding the nuances of this new regimewill be essential to optimising regulatory and commercial strategies and securing a competitive edge.

This article was first published on IAM/WTR.