Recently, the National Medical Products Administration (NMPA) issued the draft version of 'Implementation Measures for Drug Trial Data Protection (hereinafter referred to as the 'Draft for Comments'), aiming to clarify the registration categories and corresponding regulatory data protection periods for chemical drugs and biologics. The Draft for Comments is currently open for public consultation by May 18, 2025.
Innovative or improved new chemical drugs, innovative and improved biologics as well as first-to-market generics will each enjoy a period of regulatory data exclusivity up to six years. The scope of protection includes undisclosed CMC and clinical data in the initial NDA or BLA application dossiers. During the exclusivity period, the NMPA will not approve follow-on pharmaceutical products that rely on the originator’s regulatory data without the originator’s permission.
According to the Draft for Comments, the registration categories and data protection periods for chemical drugs and biologics are as follows:
Registration Categories and Data Protection Periods for Chemical Drugs
- Innovative Drugs (Category 1): Innovative drugs that have not been marketed domestically or internationally, with a data protection period of six years.
- Improved New Drugs (Category 2): Improved new drugs that have not been marketed domestically or internationally, with a data protection period of three years.
- Generic Drugs (Category 3): First-to-market generics in China, with a data protection period of three years.
- Generic Drugs (Category 4): Follow-up generics, with no data protection period.
- Imported New Drugs (Category 5):
- Imported originator drugs: Data protection period of six years minus the time difference between the date of acceptance of the NDA application in China and the date of the marketing authorization in the first approval country.
- Imported improved new drugs: Data protection period of three years minus the time difference between the date of acceptance of the NDA application in China and the date of the marketing authorization in the first approval country.
- Imported generics: Data protection period of three years.
Registration Categories and Data Protection Periods for Prophylactic Biologics
- Innovative Vaccines (Category 1): Data protection period of six years.
- Improved Vaccines (Category 2): Data protection period of three years.
- Vaccines Produced Internationally (Category 3):
- Imported originator vaccines: Data protection period of six years minus the time difference between the date of acceptance of the NDA application in China and the date of the marketing authorization in the first approval country.
- Imported originator vaccines for domestic manufacturing and BLA application: Data protection period of three years.
- Domestically marketed vaccines: No data protection period.
Registration Categories and Data Protection Periods for Therapeutic Biologics
- Innovative biologics (Category 1): Data protection period is six years.
- Improved biologics (Category 2): Data protection period is three years.
- Imported biologics (Category 3):
- Imported originator biologics: Data protection period is six years minus the time difference between the date of acceptance of the NDA application in China and the date of the marketing authorization in the first approval country.
- Imported originator biologics for domestic manufacturing and BLA application: Data protection period is three years.
- Biosimilars or other biologics: No data protection period.
The Center of Drug Evaluation (CDE) will ascertain the relevant regulatory data exclusivity periods during the NDA or BLA review and such exclusivity will be published on the CDE’s website. Follow-on applicants can submit the marketing authorization applications that rely on the originator’s regulatory data within the last year before the exclusivity expires and the marketing authorizations will be approved when the originator’s regulatory data exclusivity ends.
The publication of this draft for public comment aims to provide clearer guidance for pharmaceutical companies on data protection in China. However, specific implementation details and the final version still require further observation. We encourage relevant companies and stakeholders to actively participate in feedback to address existing ambiguities in the Draft for Comments.
