NMPA's Releases Draft Measures for Data Protection (Data Exclusivity)
In March 2025, China's National Medical Products Administration (NMPA) released yet another set of draft implementation measures on data protection.1 Key highlights of these new measures include the following:
- A maximum of six years of data exclusivity for innovative drugs, vaccines, and biologics.
- A maximum of three years of data exclusivity for modified new drugs, vaccines, and biologics and for first generic/biosimilar of an overseas original drug
- Deductions in protection periods for drugs first approved overseas, based on the time difference between overseas approval and domestic approval
A Bit of History
China's journey toward a comprehensive pharmaceutical data protection framework has been ongoing for over two decades, a roller coaster ride from its initial commitments upon joining the World Trade Organization (WTO) to its most recent draft regulations.
WTO Accession (2001) and Early Provisions (2002)
When China joined the WTO in 2001, it signed the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). In line with its WTO obligations, China incorporated data exclusivity into its domestic law in 2002 through the Regulations for the Implementation of the Drug Administration Law. These regulations provided a six-year data exclusivity period for undisclosed trial data and other independently obtained data for drugs containing new chemical entities (NCEs). This marked the first formal recognition of data exclusivity in Chinese law, aiming to prevent unfair commercial use of such data.
CDA/NMPA Draft Measure 2018
In April 2018, the China Drug Administration (then CDA, now NMPA) published “Measures for the Implementation of Data Protection for Pharmaceutical Tests (Interim) (Draft)”. Although never finalized or implemented, this Draft aimed to expand the scope of exclusivity beyond just NCEs to cover a broader range of products, including innovative drugs, orphan drugs, pediatric drugs, and biologics.
Notably, the 2018 draft proposed:
- Up to 6 years of data exclusivity for innovative drugs approved in China
- Up to 12 years for innovative therapeutic biologics
- 6 years market exclusivity for orphan drugs and pediatric drugs, regardless of data source or filing timing
- Data exclusivity for first generics that successfully challenged a patent to enter the market first
- Reducing exclusivity periods for drugs approved overseas first or drugs using overseas clinical trial data without Chinese patient data.
China’s Patent Linkage System arrives with First Generic Exclusivity
In 2020, the fourth amendment of the patent law (which introduced patent linkage) passed into law. Soon after, the Implementation Measure of the Patent Linkage System2 came down in 2021, giving 12-month market exclusivity to the first small molecule generic drug applicant to successfully invalidate a listed drug’s patent and get approval.
NMPA Draft Regulations 2022
In May 2022, the NMPA released the Draft Regulations for the Implementation of the Drug Administration Law3 (‘2022 draft regulations’) for public comments. This draft proposed market exclusivity periods for specific categories of drugs:
- New orphan drugs could receive up to seven years of market exclusivity.
- New pediatric drugs could receive up to 12 months of market exclusivity.
- First-approved generic drugs that successfully challenged an innovator patent could receive up to 12 months of market exclusivity
It also included more details on data exclusivity for confidential data, including providing 6 years data exclusivity for undisclosed experimental data and other data from “newly approved drugs.” The change in terminology from “new chemical entity” to “newly approved drug” implied that the NMPA was possibly broadening its data exclusivity protection, clarifying that protection was given to any “newly approved drug,” not just new chemical drugs. Furthermore, “newly approved” seemed to imply newly approved by the NMPA, which gave room for foreign drugs previously approved in other jurisdictions.
Unfortunately, the 2022 draft regulations were never finalized either. In 2024, a third revision of Regulations for the Implementation of the Drug Administration Law was officially issued, but none of the changes mentioned above were included.
Which brings us to today . . . .
Current Draft Measures (2025)
In March 2025, the NMPA released two new draft measures: “Implementation Measures for Data Protection (Draft for Comments)” and the “Pharmaceutical Trial Data Protection Work Procedure (Draft for Comments).”4[4]
The Framework
Key aspects of the proposed data protection periods include:
- Up to 6 Years for Innovative Drugs, Vaccines, Biologics: Innovative drugs, vaccines, and biologics can receive six years of data exclusivity from the date of the first domestic marketing authorization. For innovative drugs, vaccines, and biologics already approved overseas but not yet in China, the protection period is six years minus the time difference between the overseas approval date and the Chinese (NMPA) approval date.
- Up to 3 Years for Modified New Drugs: Modified new drugs, vaccines, or biologics can receive three years of data exclusivity from the date of the first domestic marketing authorization. Similar deductions apply for drugs, vaccines, or biologics already marketed overseas.
- 3 Years for First Generic/Biosimilar of Overseas Original Drugs: A first generic drug approved in China (including those produced overseas) or a first biological product that is a generic of an originator drug marketed overseas but not yet in China can receive three years of data exclusivity.
What Kind of Data is Protected?
For innovative drugs, the scope of protected data includes “undisclosed trial data and other data” used to demonstrate safety, efficacy, and quality control. For modified new drugs and generics, protection includes new clinical trial data demonstrating significant clinical advantages, but explicitly excludes bioavailability, bioequivalence, and vaccine immunogenicity data.
This restriction does not apply if other applicants independently obtain their own data. Additionally, applicants who wish to use the data can apply up to one year before the data expires, allowing approval to occur right at the expiration date of the data exclusivity period.
Unlike in the 2018 data protection draft and 2022 draft regulations, data/market exclusivity for specific drug categories like orphan and pediatric drugs is not included in these March 2025 draft measures.
At the end of the article are charts provided by the NMPA (translated into English) that summarize the various data exclusivity periods.
EIP Thoughts
In general, it is encouraging to see that the NMPA is working hard to create a version of data exclusively that strikes a balance between the domestic generics market, the growing domestic innovative drug industry, and the desire to bring more foreign drugs into China faster.
Bringing Foreign Drugs Into China
The deductions for overseas-approved drugs reflect China’s strategy to attract more new foreign drugs to seek marketing approval in China shortly after—or even concurrently with applying for marketing in other jurisdictions. It is understandable why China wants to encourage foreign companies to enter the China market sooner. However, such measures won’t encourage older foreign drugs that have been marketed overseas for years to enter China at all, unless if the market size and financial calculus are attractive enough to overcome such disadvantages.
It’s also quite clear that many of the draft provisions are designed to bring more foreign drugs into China. Aside from the deductions mentioned above, applicants who apply to bring into China generic drugs, vaccines, and biologics that are not yet available in China can get at least 3 years data exclusivity, and possibly up to 6 years if they bring into China a biologic or vaccine was previously only manufactured and marketed overseas.
Building Up Domestic Industries
China wants to build up its own domestic drug manufacturing capabilities, offering 3 years data exclusivity for domestic drug manufacturers who “imitate original drugs that have been marketed overseas but not yet in China.” Furthermore, applicants who apply to manufacture and market a generic biologic or vaccine that is currently not available in China can get 3 years data exclusivity.
These draft measures will indeed benefit modified drugs and generics because these two categories often struggle to obtain patent protection. As a result, having that (up to) 3 years data exclusivity fills the gap and provides another form of protection from the day of obtaining marketing approval.
For innovative drugs, although (up to) 6 years of data protection could be significantly shorter than the protection offered by the EU and (sometimes) the US, data protection offers an alternate form of protection that does not rely at all on patents. Furthermore, the draft also proposes that “[f]or innovative drugs that have been successively approved for multiple indications but share the same approval number, each indication shall be granted data protection separately according to the registration class, and the scope of data protection for new indications shall include the clinical trial data supporting their marketing.” In other words, if an innovative drug is approved for a new indication, the data related to the new indication can be protected separately, e.g., as a modified drug. This encourages research in new indications.
Orphan and Pediatric Drugs
The removal of additional data/market exclusivity for orphan and pediatric drugs (which was present in the 2018 data protection draft and 2022 draft regulations) is unfortunate, but perhaps the NMPA plans to release such provisions later. Of note, China does provide certain privileges for orphan and pediatric drugs. According to the latest Drug Administration Law (2019), expedited review and approval are available specifically for orphan and pediatric drugs.
A Few Unclear Points
There are some aspects of the draft measures that require clarification. For example, the term “undisclosed trial data and other data” is used to describe the types of data that can be protected with data exclusivity. It’s unclear whether such “undisclosed data” refers to data that has never been publicly disclosed anywhere, or just never disclosed in a Chinese marketing authorization application. If it means the former, then clinical trial data previously submitted in foreign MA applications could face significant challenges in getting any data protection in China.
The 2-month comment period closed at the end of May 2025. We’ll keep a close eye on any updates.
Table 1
Registration Classification and Data Protection Period for Chemical Drugs
Classification | Content | Data Protection Period |
Class 1 | Innovative drugs that have not been marketed in China or overseas. | 6 years |
Class 2 | Modified new drugs that have not been marketed in China or overseas. | 3 years |
Class 3 | Drugs manufactured by domestic applicants by imitating the original drugs that have been marketed overseas but not yet in China. | 3 years |
Class 4 | Drugs manufactured by domestic applicants by imitating the original drugs that have been marketed in China. | None |
Class 5 | Drugs that have been marketed overseas and are under application for marketing in China. | |
5.1 | Original drugs that have been marketed overseas and are under application for marketing in China. | 6 years - (Acceptance Date in China - Marketing Date Overseas) |
Modified drugs that have been marketed overseas and are under application for marketing in China. | 3 years - (Acceptance Date in China - Marketing Date Overseas) | |
5.2 | Generic drugs that have been marketed overseas and are under application for marketing in China. | 3 years |
Table 2
Registration Classification and Data Protection Period for Preventive Biological Products
Classification | Content | Data Protection Period |
Class 1 | Innovative vaccines | 6 years |
Class 2 | Modified vaccines | 3 years |
Class 3 | 3.1 Vaccines manufactured overseas that have been marketed overseas but not yet in China and are under application for marketing in China | 6 years - (Acceptance Date in China - Marketing Date Overseas) |
3.2 Vaccines that have been marketed overseas but not yet in China and are under application for manufacture and marketing in China | 3 years | |
3.3 Vaccines that have been marketed in China | None |
Table 3
Registration Classification and Data Protection Period for Therapeutic Biological Products
Classification | Content | Data Protection Period |
Class 1 | Innovative biological products | 6 years |
Class 2 | Modified biological products | 3 years |
Class 3 | 3.1 Biological products manufactured overseas that have been marketed overseas but not yet in China and are under application for marketing in China | 6 years - (Acceptance Date in China - Marketing Date Overseas) |
3.2 Biological products that have been marketed overseas but not yet in China and are under application for manufacture and marketing in China | 3 years | |
3.3 Biosimilars | None | |
3.4 Other biological products | None |
If you would like to have more information on this matter or would like to have our advice, please feel free to contact us at [email protected].
This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.
Implementation Measures for Data Protection (Draft for Comments) and the Pharmaceutical Trial Data Protection Work Procedure (Draft for Comments)
↩︎https://www.cnipa.gov.cn/art/2021/7/4/art_527_175022.html
↩︎https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20220509222233134.html?type=pc&m=
↩︎https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20250319181537196.html?type=pc&m=
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