The Center for Drug Evaluation (CDE), Hainan Medical Products Administration (HNMPA), and Bo’Ao Lecheng Medical Tourism Pilot Zone management bureau have jointly released a set of “Real-world Drug Research Implementation Measures.” The new rules take effect immediately, aiming to streamline the process for conducting real-world studies of clinically urgent imported drugs.
Implementation Details
The CDE will establish a communication and exchange working group for drugs in the pilot zone, while the HNMPA and Lecheng bureau will set up internal special work teams. These teams will be responsible for communication, question answering, and other services related to the research. The document clarifies that marketing authorization holders (MAHs) or agents can submit filings and protocols to the HNMPA or Lecheng bureau for preliminary review. The HNMPA will complete this review within 15 working days, and studies that pass will be forwarded to the CDE for final review within 30 working days.
Regulatory Process
Studies that meet the requirements after CDE review will be included in the pilot program, and real-world research will be conducted under the supervision and guidance of the HNMPA. After completing the real-world research, applicants can apply to the CDE for communication and exchange. Both parties can apply for registration after reaching a consensus on the research results. This policy is expected to bolster clinical studies and marketing approvals for clinically urgent imported drugs in China.
Future Implications
The implementation of these measures marks a significant step in accelerating the approval process for clinically urgent imported drugs. By facilitating real-world studies, the policy aims to provide faster access to essential medications for patients in need, enhancing public health outcomes.-Fineline Info & Tech
