On March 19, 2025, China’s National Medical Products Administration (NMPA) released draft measures and procedures for drug trial data protection, soliciting public opinions until May 18, 2025. The initiative aims to foster drug innovation and meet public medication needs, in line with relevant pharmaceutical regulations.
Data Protection Framework
The draft measures define data protection as safeguarding trial data and other independently obtained, undisclosed information when approving drugs with new chemical components or other eligible criteria. The NMPA will grant a data protection period of up to six years, during which other applicants cannot use the protected data for marketing authorization or supplementary applications without the holder’s consent, except for those who have independently obtained the data.
Protection Periods by Drug Type
The NMPA has outlined varying data protection periods for different drug categories:
- Innovative Drugs (Chemical 1, Preventive Biological 1, Therapeutic Biological 1): 6 years
- Improved New Drugs (Chemical 2, Preventive Biological 2, Therapeutic Biological 2): 3 years
- Generic Drugs Developed by Domestic Applicants (Chemical 3): 3 years
- Generic Drugs Based on Already Marketed Original Drugs (Chemical 4): No protection
- Original Drugs Marketed Abroad (Chemical 5.1, Preventive Biological 3.1, Therapeutic Biological 3.1): Protection period calculated as 6 years minus (Domestic NDA time – Foreign marketing time)
- Improved Drugs Marketed Abroad (Chemical 5.1, Preventive Biological 3.2, Therapeutic Biological 3.2): 3 years
- Biosimilar Drugs (Therapeutic Biological 3.3): No protection
- Other Biological Products (Therapeutic Biological 3.4): No protection
Implementation Process
Under NMPA guidance, the Center for Drug Evaluation (CDE) will oversee data protection implementation. When accepting marketing authorization applications for chemical drugs and biological products, the CDE will concurrently review data protection applications, determining eligibility and specifying the scope and duration of protection.-Fineline Info & Tech
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