С 15 мая 2026 года в Китае вступил в силу новый режим защиты клинических данных лекарственных препаратов

On May 15, 2026, a substantial revision of China’s Implementing Regulations of the Drug Administration Law (the Regulations or Implementing Regulations) took effect, introducing, among other items, a formal data protection framework. On the same day, China’s National Medical Products Administration (NMPA) issued the Implementing Measures for Drug Trial Data Protection (the Measures), giving operational effect to the Regulations’ data-protection article for the first time since China accepted the underlying obligation upon World Trade Organization (WTO) accession. Until 2026, an innovator’s return in China depended almost entirely on patents and price. It now depends on a four-layer architecture, and a China clinical dataset has become a defined, publicly recorded, and contractually transferable regulatory asset. This GT Advisory covers the exclusivity side of China’s 2026 reforms. A companion Advisory covers the cost side — the rebuilt Good Clinical Practice standard, which takes effect Sept. 1, 2026. I. The Four-Layer Protection Architecture China introduced regulatory data protection in 2002 upon WTO accession, but the principle sat in the text for two decades without implementing machinery. The competitive consequence was notable: as we discussed in our July 2025 GT Advisory, at least 23 Chinese companies were developing semaglutide biosimilars by January 2025, notwithstanding that the originator’s compound patent remained in force. The Implementing Regulations, published Jan. 16, 2026, and effective May 15, 2026, closed that gap. Two articles of the Regulations are particularly relevant here. Article 22 of the Regulations protects self-obtained, undisclosed trial, and other data submitted by holders of drugs containing new chemical entities and other qualifying drugs. It also prohibits unfair commercial use, giving effect to a principle the Measures implement. Article 21 of the Regulations establishes market exclusivity for the first time at administrative regulation level: up to two years for qualifying pediatric drugs and up to seven years for qualifying rare disease drugs conditioned on a supply commitment; failure to satisfy that commitment terminates the exclusivity. Article 10 of the Regulations separately codifies acceptance of overseas research data meeting NMPA requirements. The distinction between the last two layers cuts in favor of the fourth. Data protection blocks only reliance; a competitor with its own complete dataset may still be approved. Market exclusivity blocks approval of the same variety regardless of the data source, making it the closest Chinese analogue to U.S. new chemical entity and orphan exclusivity. For a rare disease molecule, it may deliver more than the six-year data protection term, and the two can run in parallel. How the Layers Compare With the United States and Europe For sponsors accustomed to Hatch-Waxman Act, the Biologics Price Competition and Innovation Act (BPCIA), and the EU incentive framework, the following places China’s new architecture in context. The European position is stated as it currently stands; the reform package agreed in 2026 restructures it further, with most provisions expected to apply from around 2028. Two features distinguish China from both benchmarks. The pediatric term is standalone market exclusivity rather than an add-on to something the sponsor already holds, which means it is available to a product with no remaining patent or exclusivity runway. Additionally, China conditions its rare disease term on continuing supply — which is not a Chinese peculiarity: the EU reform likewise ties market protection extensions to genuine commercial presence and timely launch across Member States. Both jurisdictions are moving toward exclusivity earned by availability rather than granted on approval, while the United States does not condition its orphan term in the same way. Sponsors used to treating exclusivity as a fixed entitlement may instead need to underwrite supply commitments in two of their three major markets. Two questions under Article 21 of the Regulations remain open. First, nothing states whether an asset approved between May 15, 2026, and the date China’s implementing measures issue can claim exclusivity retroactively — though the Regulations’ own six-year look-back for new chemical entities is a helpful, if non-binding, precedent. Second, the Implementation Regulations set only maximum exclusivity periods — “up to” seven years for rare disease drugs and “up to” two years for pediatric drugs. They do not establish clear standards for how long exclusivity will actually be granted for the specific drug. In addition, the exclusivity is only available to “qualifying” rare disease drugs (subject to a supply-commitment condition), yet the specific qualifications or conditions that must be met have not been defined. Both the standards for determining the actual duration of exclusivity and the detailed eligibility criteria therefore still await clarification in subsequent implementing rules. At present, it remains unclear how rare disease drugs or pediatric drugs may apply for or obtain market exclusivity, as the detailed implementing measures have not yet been issued. To preserve optionality, sponsors may wish to begin assembling the designation, epidemiology, and supply-capacity record now; raise retroactivity on a named asset through the CDE communication channel; and submit substantive comments when the draft measures are released. II. What Changed Between the Draft and the Final Rule NMPA issued the Measures under its Announcement No. 47 on May 15, 2026, effective immediately, and released the CDE Working Procedures and a transition notice the same day. Three changes from the March 19, 2025 consultation draft analyzed in our July 2025 GT Advisory materially alter the analysis. - The reduction formula was abandoned. The draft would have cut the term for an ex-China originator by the interval between first overseas approval and China acceptance. Our July 2025 Advisory flagged that “first overseas approval” was never defined. The final Measures resolve that by deleting the formula: Article 5 of the Measures grants a flat six years from first China marketing authorization, whatever the prior overseas history. - Improved drugs moved from three years to four, and Article 6 of the Measures extends the same term to improved drugs already marketed outside China that are filing in China for the first time. - Rare disease and pediatric protection did not land here. Both surface instead as Regulations’ Article 21 market exclusivity — a different and stronger mechanism, on a separate timetable. A Worked Example: The Case for Filing China First On July 22, 2026, the NMPA approved Takeda’s Orzeyful (oveporexton) for narcolepsy type 1 — the first approval of the product anywhere in the world. The company’s China application was accepted in January 2026 and granted priority review; the U.S. application was approved on Aug. 5, 2026, and the Japanese application remains under review. A product not marketed anywhere before its China approval falls in Chemical Class 1 and attracts the full six years, with protected scope covering the entire dossier demonstrating safety, efficacy, and quality controllability. The approval rested substantially on global Phase III data, which Article 10 of the revised Regulations now expressly permits. China has become a jurisdiction in which a first-in-world approval is achievable on a global data package, on a timeline competitive with the United States and Japan, with six years attaching on approval. That warrants a review of sequencing assumptions rather than a default that China follows. Three Definitions That Help Decide Eligibility - “Undisclosed” means not completely disclosed. Per the NMPA’s May 15, 2026, policy interpretation on the Measures, partial disclosure leaves the dataset as a whole still undisclosed; only publication of the complete dataset defeats protection. Registry postings and summary results therefore do not defeat protection; publication of the complete dataset does. Disclosure discipline is now a legal control, not a communications preference. - “Self-obtained” includes acquired data. The NMPA confirms it covers commissioned research and data acquired by purchase or exclusive license. In-licensed datasets can therefore carry protection in the licensee’s hands, which raises the value of clean, exclusive, documented data rights in diligence — including for Chinese investigator-initiated trial data now increasingly used in global rare disease programs. - The protected scope reaches manufacturing and quality data. Article 5 of the Measures protects all dossier data demonstrating safety, efficacy, and quality controllability, the third limb capturing the CMC package. Articles 6 and 8 of the Measures are narrower, confined to clinical data and excluding bioavailability, bioequivalence, and vaccine immunogenicity data. Article 4 additionally requires the data to be first used in China for a marketing authorization application, and to be complete. III. Protection Terms Chemical Drugs Vaccines and Therapeutic Biologics Where an innovative drug obtains several indications under one approval number, each is protected separately by registration category, with the added-indication scope limited to the data supporting it. Under Article 7 of the Measures, an ex-China originator filing first in China for an indication not approved anywhere receives six years across the dataset; later indications receive four. What Protection Does and Does Not Do - It withholds approval; it does not bar filing. Article 12 of the Measures permits reliant applications in the final 12 months, with the CDE completing technical review, suspending the clock, and approving upon expiration. China is a reliance-blocking regime, not an application-blocking one. - The block is asymmetric. Article 5 of the Measures blocks improved new drugs, generics, and biosimilars. Articles 6 and 8 of the Measures block only generics and biosimilars — so a four-year improved-drug term does not exclude a competing improved new drug. - Independent-data entry is permitted but not rewarded. Article 3 of the Measures permits independent data entry but grants it no reward: such an entrant receives no data-protection period of its own, and its data is walled off from later applicants; Article 12 of the Measures refuses an application where a self-obtained claim proves false on review — i.e., where the applicant in fact relied on another’s protected data without consent. - Protection is a status, not a vested term. Article 3 of the Measures contains a public health emergency and public interest override, and Article 13 of the Measures terminates protection on revocation, cancellation, deregistration, or voluntary waiver, with a published announcement after which reliant applications may proceed. IV. The Manufacturing-Location Cliff An important feature for multinationals sits in the appendix tables of the Measures rather than the operative articles. For vaccines and therapeutic biologics, classification turns on where the product is made: products manufactured overseas and filed for China marketing fall in Class 3.1 at six years; products filed for manufacture inside China fall in Class 3.2 at three years. A non-originator import also receives three years’ worth of protection. The full term goes to the originator that imports and is halved for the one that localizes from the outset — running against the direction of travel in China market strategy, including the device localization pathway we analyzed in July 2025. Two structurally different maneuvers may easily be conflated, but the distinction decides the answer. Transferring manufacturing under an existing marketing authorization by supplemental application is not yet resolved: under the Measures, Article 3 fixes the clock at approval and Article 13’s termination grounds do not include a site change, which supports the term surviving, but the CDE could equally treat the transfer as converting the product into the category the tables assign three years. A separate application by a licensee to manufacture and market in China is a distinct Class 3.2 registration drawing its own three-year term from its own approval date. Sequenced Localization An originator that first obtains approval as an import secures six years of data protection. It may then transfer production to a China manufacturer (with the required consent). Under the official interpretation of the Measures, the domestically manufactured product may continue to benefit from the remaining term of the original data-protection period rather than starting an independent new term. During that period, the NMPA will not approve reliant generic or biosimilar applications that rely on either the imported or the domestically produced originator data without the holder’s consent. Choosing local manufacture as the first and only filing therefore carries a real consequence: the product may receive only the shorter three-year protection available to a first Class 3.2-type application. Treating localization as a subsequent step after an import approval, by contrast, allows the sponsor to lock in the full six-year term and then transfer production while preserving that protection. Stakeholders may therefore consider first seeking marketing approval in China as an import, rather than first localizing production. V. Interaction With Patent Linkage The final-year filing window provided under the Measures and the nine-month stay under the 2021 patent linkage measures both operate on administrative approval rather than acceptance or technical review, so they stack: a challenger filing in the final year and then triggering a stay faces two independent suspensions, and approval waits for the later of the two to lift. Another important point is the gap in scope. The nine-month stay is available only for chemical generic applications; it does not extend to biosimilars. For a therapeutic biologic, the six-year data protection term is therefore the only approval-blocking layer in the architecture until the implementing measures for Article 21 of the Regulations issue. Patents remain enforceable but require litigation and do not stop the NMPA granting approval. Sponsors of biologics may wish to treat the accuracy of the protection request and the maintenance of protection status as carrying more weight than the equivalent step for a small molecule. VI. Procedure and the Closed Transition Windows Protection is not automatic. The request must be filed simultaneously with the marketing authorization application; the CDE flags the variety at acceptance, fixes scope and term during technical review, annotates the approval certificate, and publishes on its portal. Article 9 permits communication meetings on data protection questions before filing or during review, and unresolved disputes are escalated to the NMPA — so a proposed term or scope is contestable during review rather than after it is fixed. Under the Measures, certain products that were approved or under review as of May 15, 2026, had a short, one-time opportunity (until June 5, 2026) to apply for data protection. The transition windows have now closed. Stakeholders should therefore consider: (i) for already marketed or previous pending products, auditing eligibility, timely filing and formal recording of any data protection, rather than assuming a further opportunity remains; and (ii) for future products: filing any data-protection request simultaneously with the marketing authorization application, as protection is not granted automatically. One point on the second row requires care in any audit. Announcement No. 47 provides 15 days, which on a calendar-day reading closed on May 30, 2026. The CDE’s published a question-and-answer set on June 5, 2026, for the retroactive already marketed Chemical Class 1 route, and PRC commentators have read the 15-day period as 15 working days, which would align all three categories at June 5. The public materials do not resolve which basis the CDE applied to the earlier categories. Any request filed between May 30, 2026, and June 5, 2026, should therefore be confirmed with the CDE rather than assumed timely. A late request is a deemed waiver for that application and cannot be revived. The remaining prospective route is Article 5 of the Measures: because each indication is protected separately by registration category, a future supplemental application for a new indication may carry its own protection request even where the original approval did not. Sponsors may wish to confirm in writing which China-approved products currently carry recorded protection and which do not. VII. The Consent to Data Reliance Agreement Under the CDE Working Procedures, a reliant application may be accepted where the holder consents and the parties execute a Consent to Data Reliance Agreement in a prescribed form. Consent is therefore now a discrete, documented right with immediate regulatory effect — it can be granted, withheld, priced, staged, or traded, and it does not depend on the holder’s continuing cooperation once given. Agreements predating May 15, 2026 may not address the point, and stakeholders should consider resolving that where the counterparty is a potential competitor in the same molecule. In practice, stakeholders may wish to include consent to reliance on the deal sheet as a named closing deliverable and a separately negotiated right, in the same way as a right of reference — not assumed to travel with the marketing authorization. To that end, stakeholders may wish to consider the following steps when drafting transaction agreements: VIII. Next Steps For companies with China filings or China-facing transaction and localization plans, the new regime may require coordinated review across regulatory, IP, business development, and technical operations functions. Accordingly, stakeholders may wish to consider the following: Conclusion China has spent a decade working to make itself a more attractive jurisdiction for clinical trials. The May 2026 package is the first to make the resulting data legally valuable. As a next step, stakeholders should consider completing an audit of which China assets carry recorded protection, re-examining their filing sequence now that the late-filing penalty is gone, and contemplating their manufacturing footprint decision with the Class 3.1 and 3.2 differential in view. Our companion Advisory addresses the other half of the regulations: the rebuilt GCP and the contract and site changes it requires. We operate a free-to-view policy, asking only that you register in order to read all of our content. Please login or register to view the rest of this article.