China's Pharmaceutical Regulatory Update: Faster Routes to Market, Stronger IP and Data Protection

Authors: 

• Alison Wong (Joint Managing Partner, Greater China, APAC Head of Life Sciences & Healthcare)
• Lily Zhang (Partner, Twobirds Lawjay Association Team)

On 27 January 2026, the State Council promulgated the revised Implementing Regulations of the Drug Administration Law of the People’s Republic of China (hereinafter referred to as the "Regulations"), which will take effect on 15 May 2026.

The Regulations elaborate and refine key provisions under the Drug Administration Law of the People’s Republic of China (the "Drug Administration Law"), in force since 1 December 2019, and are designed to ensure its effective implementation.

This long‑anticipated update brings clarity to major aspects of pharmaceutical regulation and will enable companies to better plan their strategies for the China market. By strengthening innovation incentives — including enhanced data protection and data exclusivity — the Regulations underscore China’s commitment to fostering a more innovation‑friendly pharmaceutical ecosystem.

Key Provisions of the Regulations

Stronger support for innovation and accelerated market access pathways

The Regulations emphasise support for drug research and innovation guided by clinical value. Drug regulatory authorities may employ accelerated market access mechanisms — including breakthrough therapy designation, conditional approval, priority review and approval, and special approval procedures — for eligible drug registration applications to expedite market authorisation.

Qualifying paediatric medicines — Up to 2 years of market exclusivity

New paediatric drug varieties, paediatric medicines using novel dosage forms or specifications, and medicines with expanded paediatric indications that meet specified criteria will be eligible for a market exclusivity period of up to 2 years.

Orphan drugs — Up to 7 years of market exclusivity

Orphan drugs that meet the relevant criteria may receive market exclusivity of up to 7 years, provided the marketing authorisation holder (the "MAH") commits to ensuring supply. Exclusivity may be terminated if the MAH fails to meet this supply obligation.

Medicinal products containing novel chemical entities — Up to 6 years of data protection

The Regulations establish a medicinal product trial data protection regime designed to safeguard independently obtained, undisclosed trial data submitted by MAHs. This sends a strong signal in favour of innovation and R&D investment.

Protection applies to undisclosed trial data and other data independently generated and submitted by MAHs for medicinal products containing novel chemical entities and other eligible products. No party may improperly commercialise such data during the protection period, which may extend up to 6 years from the date of marketing authorisation.

During this period, drug registration applications relying on such protected data may not be approved without the MAH’s consent, unless the applicant submits independently obtained data.

Regulators may not disclose protected data except where necessary in the public interest or where measures have been taken to ensure the data will not be improperly exploited.

On 19 March 2025, the National Medical Products Administration (NMPA) initiated a two‑month public consultation on the Implementation Measures for the Protection of Drug Trial Data (Trial, Draft for Comments) and the Working Procedures for the Protection of Drug Trial Data (Draft for Comments).

At the National Drug Supervision and Administration Work Conference on 6 January 2026, Li LI, Commissioner of the NMPA, stated that the agency would advance implementation of the drug trial data protection system in 2026. Further details — for example, whether the 6‑year protection period will apply to biologics — are expected later in the year.

Our Preliminary Recommendations

Capitalise on opportunities arising from regulatory and system reforms

Make full use of accelerated market access pathways such as breakthrough therapy designation, conditional approval, and priority review mechanisms. For innovative drugs addressing life‑threatening conditions or rare diseases, these expedited routes can significantly shorten the path to commercialisation.

Seek market exclusivity and data protection where applicable

For products containing novel chemical entities, ensure full understanding of data protection policies to benefit from up to 6 years of protection. For paediatric medicines and rare disease treatments, pursue market exclusivity to secure return on R&D investment.

If you have any questions regarding specific provisions or implementation details under the Drug Administration Law or the Regulations, or if you require support with compliance assessments, system enhancements, or licensing applications, please feel free to contact us.