China's New Regulatory Data Protection Regime Becomes Effective Immediately
On May 15, 2026, China's National Medical Products Administration ("NMPA") announced the Implementation Measures for Regulatory Data Protection (the "Measures"), which took effect on the same day, ushering in China's clinical data exclusivity framework for pharmaceuticals.
The Measures establish a tiered regulatory data protection ("RDP") regime granting up to six years of data exclusivity, reshaping the competitive landscape for innovative and generic drugs. The regime covers chemical drugs and biologics, including therapeutic and preventive biologics. Notably, the Measures afford imported and domestically manufactured drugs equal protection.
Tiered RDP Periods
The Measures establish a tiered RDP duration following the NMPA approval categories (see Tables 1–3 below):
- Six years of RDP for innovative drugs (Category 1) and overseas-marketed originator drugs first launched domestically (Category 5.1 for innovative chemical drugs, or Category 3.1 for biologics);
- Four years of RDP for improved drugs (Category 2, or Category 5.1 for overseas-marketed improved chemical drugs); and
- Three years of RDP for first-to-file generic drugs of overseas-marketed but domestically unavailable originator drugs (Category 3 and 5.2 for chemical drugs, or Category 3.2 for biologics).
In addition, when a globally novel indication for an overseas-marketed originator drug is approved with a complete data package, the RDP duration is six years.
Protected data encompasses pharmacological, nonclinical, and clinical trial data used to demonstrate safety, efficacy, and quality, but excludes bioavailability, bioequivalence, and vaccine immunogenicity data.
Operational Principles
During the data protection period, NMPA will not approve marketing applications for improved or generic drugs that rely on the protected data without the holder's consent. Applications relying on protected data may be accepted within one year only before the protection period expires. Applicants who independently generate their own data remain unaffected. Note that data protection is not automatically granted but must be applied for simultaneously with marketing authorization applications.
Transitional Provisions
For drugs that have already been approved or are currently under review as of the effective date of May 15, 2026, marketing authorization holders or applicants may submit a data protection application to the Center for Drug Evaluation within 15 working days of the effective date, i.e., no later than June 5, 2026.
Table 1: Registration Classification and Data Protection Period for Chemical Drugs
Table 2: Registration Classification and Data Protection Period for Preventive Biological Products
Table 3: Registration Classification and Data Protection Period for Therapeutic Biological Products
