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Marking a milestone in China's drug regulatory landscape, the 2026 Revisions of China's Drug Administration Law introduce data exclusivity and market exclusivity into the regulatory framework, establishing a multi-dimensional protection system along with patent rights.
This expected development provides innovative drugs with new institutional protection beyond patents, we look at their practical implications.
On 27 January 2026, the State Council of the People's Republic of China released the Implementing Regulations of the Drug Administration Law (2026 Revisions), which will take effect on 15 May 2026.
We review the scope, terms, conditions and regulatory rationale of data exclusivity and market exclusivity under these revisions, and assesses their practical impact on pharmaceutical R&D and registration strategies.
Market exclusivity
The 2026 Revisions introduce market exclusivity to eligible pediatric medicines and orphan drugs.
- Pediatric m edicines: A market exclusivity period of up to two years may be granted to eligible new pediatric drugs, including those with new dosage forms, specifications, or expanded pediatric indications.
- Orphan drugs: A market exclusivity period of up to seven years may be granted for eligible orphan drugs, which is conditional on the Marketing Authorisation Holder (MAH) committing to a guaranteed drug supply. Otherwise, this exclusivity will be terminated early if the MAH fails to fulfill the supply obligations.
This is the first time that market exclusivity system has been introduced into China's drug regulatory framework, and the provisions reflect the policy inclination towards pediatric drugs and orphan drugs.
For pediatric drugs, the broad coverage of new dosage forms, specifications, and indications creates opportunities for enterprises with strengths in pediatric pharmaceutical innovation to consolidate their market position.
Subsequent supporting implementation rules will be further formulated by the National Medical Products Administration (NMPA).
Data exclusivity
The 2026 Revisions also establish a medicinal product trial data protection regime designed to safeguard independently obtained, undisclosed trial data submitted by MAHs. Data exclusivity prevents other applicants from unfairly relying on proprietary research data submitted in support of marketing authorisation.
Under the new regulations, a protection period of up to 6 years may be granted for undisclosed trial data and other data that is independently generated and submitted by MAHs for drugs containing new chemical component and other eligible drugs.
During this period, drug registration applications by other applicants relying on the same data without the MAH's consent willnot be approved. However, this restriction does not apply if the applicants submit independently obtained data.
Protected v unprotected data
The drug regulatory authority shall not disclose protected data except under the following circumstances:
- the disclosure is required for public interest
- measures have been taken to ensure that such data will not be improperly used for commercial purposes.
Detailed measures shall be formulated by NMPA in due course. Nonetheless, the 'Measures for the Implementation Measures for the Protection of Drug Trial Data (Trial, Draft for Comments)' issued by the National Medical Products Administration (NMPA) on March 19, 2025may offer insights into the future implementation approach.
Trial measures may offer implementation insights
Under the Trial Measures, data protection (ie, data exclusivity) applies to innovative drugs, improved new drugs, and generic drugs with respect to self-obtained and undisclosed trial data and other data submitted by an applicant. An application for data protection should be submitted simultaneously with the drug marketing authorisation application.
Innovative drugs
A 6-year data exclusivity period may be granted for innovative drugs from the date of their first marketing authorisation in China. For an original drug/biologic that has been marketed overseas before its marketing approval in China, the data exclusivity will be calculated as 6 years minus the period between domestic application acceptance date and oversea listing date.
For innovative drugs that have been approved for multiple indications under the same approval number, each indication will be given data protection according to the registration category.
Improved new drugs
A 3-year data exclusivity period may be granted for improved new drugs from the date of their first marketing authorisation in China. For an improved drug that has been marketed overseas before its marketing approval in China, the data exclusivity will be calculated as 3 years minus the period between domestic application acceptance date and oversea listing date.
Generic drugs
A 3-year data exclusivity period may be granted to the first approved generic drug (including those manufactured overseas) and biologic that have been marketed overseas but not in China. The data exclusivity period is calculated starting from the date on which the generic drug or biologic obtains marketing authorisation.
The Trial Measures
- classify data protection periods based on innovative drugs, improved new drugs, generic drugs, and biological products
- adjust the calculation mechanism for data protection periods, and
- include provisions such as deduction rules for the time gap between the first overseas listing and domestic marketing approvals, as well as incentives for first generic drugs.
We look forward to the detailed implementing rules and will continue to monitor for updates.
What this means for pharmaceutical R&D
The official introduction of data exclusivity and market exclusivity systems in the 2026 Regulations for the Implementation of the Drug Administration Law mark a significant advancement in China's drug regulatory reform.
These two forms of regulatory exclusivity enhance protection for innovative achievements, incentivise R&D in rare diseases and pediatrics, and support the high-quality development of the pharmaceutical industry.
How we can help
For pharmaceutical enterprises, a thorough understanding and strategic application of these new rules will be essential in optimising R&D planning, enhancing asset value, and strengthening competitiveness in both domestic and global markets.
Our teams in Hong Kong and Beijing are well versed in Chinese IP law and can assist with a wide range of filing prosecution and strategies. Should you have any questions regarding the regulatory exclusivity in China, please reach out to the authors or your Spruson & Ferguson contact.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
