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NMPA Notice: Guideline Draft on the Usage of Real-world Data in Clinical Evaluation
2019-12-17 18:00


On December 13, National Medical Product Administration (NMPA) of China released a draft "Guideline on the use of real-world data in clinical evaluation". NMPA has formerly launched an China Regulatory's Scientific Action Plan to improve existing medical device governance system with the objectives to open new ways to foster innovations and support the growth of medical device industry in China.  


In April 2019, NMPA initially introduced a research project to investigate the use of real-world data for clinical evaluation of medical devices. It is believed that new solutions can increase the efficiency of the review system and accelerate the market launch of innovative medical devices. The project is led by the NMPA's device registration and administration departments, and executed by Center of Medical Device Evaluation (CMDE). Sichuan University, Zhejiang University, Peking University, and Hainan province's NMPA jointly collaborated in this project.


Real-world data (RWD) definition by NMPA

Real-world data is the data derived from sources of real-time medical environments, apart from traditional clinical trial, which reflects patient’s health conditions and medical procedure during the actual diagnosis and treatment cycle. 


Following are some examples medical device manufacturers can consider to supplement real-world data to NMPA:

  1. Clinical evaluation path with predicate (provide predicate's clinical/ registration data)

  2. Reference device's clinical data, design feature, intented use as a supportive evidence to support product registration

  3. RWD-generated from licensed use of clinically urgent-need imported medical devices in China as a supportive evidence to support product registration

  4. Support the change of intended use and indication for use

  5. Long-term safety and effectiveness evaluation of high-risk implants

  6. Post-market surveillance of medical device

       ...


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