Acceptance of Foreign Clinical Trial Data

Enhanced Acceptance of Foreign Clinical Trial Data.

On 08.10.2017, the CPC Central Committee and State Council published “Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices (Draft for Comment)”. According to this, NMPA plans to accept foreign clinical trial data if it complies with Chinese requirements.

NMPA comments on the following aspects of clinical trial management:

1. Speeding up the review and approval of market entry
2. Promoting drug innovation and generic drug development
3. Strengthening the lifecycle management of pharmaceutical and MD
4. Improving technical support
5. Strengthening organization and implementation