As China’s first framework to protect pharmaceutical trial data, independent of the patent system, is widely considered a boost for drug development, some lawyers say disputes may arise if companies are ill-prepared.
The Implementation Measures for Drug Trial Data Protection (the measures), issued by the National Medical Products Administration (NMPA), formally took effect on 15 May 2026. Under the rules, eligible chemical drugs and biologics will receive up to six years of data protection on receiving marketing approval. It covers self-generated, and undisclosed trial and other data submitted by the applicant.
Innovative drugs not previously marketed within or outside China are eligible for the longest protection period of six years. Original drugs already marketed overseas, but approved in China for the first time will also enjoy six years’ protection.
For generics, where the originator has been marketed abroad but not in China, the first generic approved domestically will be granted three years of protection.
Aaron Gu, a partner at Han Kun Law Offices in Shanghai, told China Business Law Journal: “The new rules inject fresh momentum into innovative drug development and significantly enhance the pipeline value of innovative products. In licensing transactions, the data protection period may also enable innovative drug companies to command higher royalties.”
He advised innovative drug companies to adopt a “comprehensive, multi-tiered” patent strategy aimed at maximising delay of the patent cliff.
Regarding products with multiple potential indications, he said: “[The company] should carefully choose the first indication for launch in China to secure the maximum six-year protection period and optimise returns.”
Zhou Hanshuo, a partner at Jingtian & Gongcheng in Shanghai, said: “Innovative drug companies can deploy layered protection strategies, covering core compound patents, formulation improvement patents and indication expansion patents. They may consider separating different indications into independent filing units to obtain separate data protection periods. This can prevent exposure of data for one indication from affecting others.”
Yan Chunhui, a partner at Zhong Lun Law Firm in Beijing, said: “The data protection period can be used independently or in combination with patent terms and fixed contractual periods to determine the revenue?sharing term in business development transactions.”
For generic drug companies, Zhou said: “The immediate impact of the new rules is that generics can no longer simply rely on publicly available originator data for registration, raising R&D costs and lengthening market entry timelines.”
She said that, in addition to competing for first?generic status, companies should “prepare on multiple fronts”, including seeking data reference rights or licences from originators.
Gu agreed that the rules posed hurdles for generics, advising companies to monitor the expiry of originators’ data protection periods, and align development and launch timelines accordingly.
Yan added that, while generic companies should pay close attention to products whose protection would expire within a year to secure an early filing window, they should also strengthen their own data generation capabilities. “Biosimilars themselves do not enjoy data protection. The evidentiary threshold for independently demonstrating safety and efficacy may instead become a competitive barrier,” he said.
Some provisions in the measures remained uncertain, including whether subsequent generic applications would be deemed to rely on data from the first generic, and how the boundary of “undisclosed” data would be defined, Yan said.
“Such determinations will directly affect the scope of protection and are likely to become a hotspot for future disputes,” he said. The measures also did not clearly address whether generics might circumvent protection by carving out protected indications, he added.
In its policy guidance, the NMPA said that “undisclosed” meant that the relevant trial data had not been fully disclosed; even partial disclosure did not render the overall dataset disclosed.
Zhou said, however, that in practice, disputes were unlikely to turn on a literal “all or part” distinction, but rather on whether the specific data claimed as exclusive by the originator had been substantially disclosed – particularly clinical study reports, key appendices, methodologies and safety details.
“In the event of a dispute, pharmaceutical companies must clearly delineate between publicly disclosed fragments and the protected data package, and maintain a robust chain of title for self?generated data. Otherwise, claims of ‘undisclosed’ status may be vulnerable to challenge by generics,” she said.
For multinational pharmaceutical companies marketing products in China, Zhou said: “Foreign firms must treat China filing materials as independent assets and protect core data carefully to avoid losing exclusivity.”
She also said: “The essence of this new regime is to protect the data package submitted in China, rather than to penalise prior launches in the US or Europe.”
Yan said foreign companies should reassess their global filing strategies by advancing China submissions to a stage before overseas data disclosure, or by generating China-specific bridging data to meet the “first approval in China” requirement.
