China releases draft of new working procedures for pharmaceutical trial data protection

On 19 March  2025, China’s National Medical Products Administration (NMPA) released a draft of the draft Implementing Measures for Pharmaceutical Trial Data Protection for trial implementation (covered in this previous Law-Now article). According to these Draft Measures, innovative drugs, improved new drugs, and first generic drugs can apply for a data protection period of three to six years.

Alongside the Draft Measures, the NMPA also released the draft Working Procedures for Drug Trial Data Protection on the same day, serving as a companion implementation document to the Draft Measures. These Draft Procedures provide the detailed process for data protection applications, the handling of generic drug applications during the data protection period, and the consequences of data protection period expiration or termination.

The following article outlines the key parts of the Draft Procedures:

1. Data protection application process

Innovative drugs, improved new drugs, and first generic drug may apply for data protection through the following procedures:

• Timing of application: Applicants must submit a data protection application simultaneously with their drug marketing authorisation application. The Centre for Drug Evaluation (CDE) under the guidance of NMPA will review both applications concurrently.
• Application publication and objections: Data protection application details will be published by the CDE.  During the technical review period, other applicants will have the opportunity to raise objections to the CDE and submit relevant supporting documents.
• Publication of data protection status: For drugs granted data protection upon approval, the CDE will publish key information, including the drug name, approval number, specifications, marketing authorisation holder, approval date, data protection period, scope of protection, and expiration date.

2. Handling of generic drug applications during the data protection period

During the data protection period, unless the original holder's consent is obtained or independently acquired data is submitted, the CDE will in principle not accept or approve marketing authorisation or supplemental applications from other applicants relying on the protected data. Specifically:

• Time restrictions: Once a drug has been granted data protection, generic drug applicants may only submit a marketing authorisation or supplemental application relying on the protected data within one year before the data protection period expires.
• Exceptions: Applicants who have independently obtained trial data or have received the MAH’s consent to rely on protected data may submit an application at any time.
• Review suspension: If the CDE completes the technical review of the generic drug while the relevant trial data is still within the data protection period and the applicant has not received the MAH’s consent to rely on protected data, the review will be suspended until the protection period expires.

3. Consequences of data protection expiration or termination

After the data protection period expires or is terminated, relevant applications for generic drugs may be resumed. Specifically:

• Expiration: Fourteen days before the data protection period expires, the review of previously suspended generic drug applications will resume.
• Termination: If data protection is terminated before its expiration date, from the date the termination decision is made the CDE may begin accepting generic drug applications from other applicants relying on the previously protected data. The review of previously suspended generic drug applications will also resume.

Conclusion

While these Draft Procedures provide a foundational framework for the implementation of the pharmaceutical trial data protection regime, several key details, such as the duration of the publication period and the process for challenging data protection applications, remain unaddressed. These specifics are expected to be clarified in the final version of the text and during the implementation phase.

CMS will closely monitor the progress of the public consultation and any subsequent updates.

For more information on China’s pharmaceutical data protection policies, contact your CMS client partner or one of these CMS experts: