China's New Draft Rule on Regulatory Data Exclusivity for Drugs

On 19 March 2025, the National Medical Products Administration (NMPA) issued the Draft Implementation Measures for Drug Trial Data Protection (Trial) and the accompanying Draft Procedures for Drug Trial Data Protection for public comment (collectively, the “2025 Draft for Comment”). Comments are due on 18 May 2025.₁

Since the release of the Implementation Measures for Drug Trial Data Protection (Interim) (Draft for Comment) (the “2018 Draft for Comment”)₂ in 2018, industry stakeholders have been keenly focused on the timing and approach for implementing China's regulatory data exclusivity regime. In 2024, the NMPA also sought opinions from certain trade associations and companies on a small scale to draft internal amendments based on the 2018 Draft for Comment. The emergence of the 2025 Draft for Comment, now issued for public comment, marks a new milestone in this legislative effort.

This article aims to provide an in-depth analysis and commentary on the 2025 Draft for Comment from the perspectives of historical development, key points, and suggestions for improvement.

Historical Development and Sources of Law of China’s Regulatory Data Exclusivity

• In 2001, China joined the World Trade Organization (WTO) and signed the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)₃, where the regulatory data exclusivity regime was first introduced to China through this international agreement.

• In 2002, the Regulations for the Implementation of the Drug Administration Law₄ incorporated the principle of regulatory data exclusivity into Chinese domestic law for the first time. It provided protection for undisclosed trial data and other data independently obtained for drugs containing new chemical entities, with a protection period of six years.

• In 2013, China signed the China-Switzerland Free Trade Agreement₅, which provided a broader scope of protection for the data protection period compared to the Regulations for the Implementation of the Drug Administration Law, including both chemical drugs and biological products.

_{1 The Draft Implementation Measures for Drug Trial Data Protection (Trial) and the Draft Procedures for Drug Trial Data Protection were issued by the General Office of the NMPA on 19 March 2025 for public comments, https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20250319181537196.html
2 The Implementation Measures for Drug Trial Data Protection (Interim) (Draft for Comment) was issued by the Office of the NMPA on 25 April 2018 for public comments, https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/zhqyj/zhqyjyp/20180426171801468.html
3 The TRIPS Agreement is one of the fundamental agreements signed by China upon joining the WTO in 2001, http://ipr.mofcom.gov.cn/zhuanti/law/conventions/wto/trips.html
4 The Regulations for the Implementation of the Drug Administration Law (Decree No. 360 of the State Council) issued on 4 August 2002, https://www.gov.cn/gongbao/content/2002/content_61719.html
5 The China-Switzerland Free Trade Agreement was signed and issued by the governments of China and Switzerland on 6 July 2013, http://fta.mofcom.gov.cn/article/chinaswitz/chinaswitznews/201509/28692_1.html}