The China NMPA (National Medical Products Administration) is seeking input on whether real world data can be used for Clinical Evaluation Reports. This is a potentially very significant development and Cisema will submit a proposal to the NMPA before the consultation period ends on 13 January 2020. Please provide to us your opinions on the guidelines as soon as possible and in any event prior to the deadline so we can together submit a strong submission to the NMPA.
On 13.12.2019, the NMPA released a draft of The Technical Guidelines for the Application of Real-World Data in Clinical Evaluation of Medical Devices. As part of the medical device registration, companies have to submit a Clinical Evaluation Report (CER). Identifying qualified clinical data for this report has been one of the biggest obstacles for foreign medical device companies in China. In order to avoid clinical trials in China, other clinical data sources have been introduced in the past years, including predicate devices and data derived from abroad.
Now, the NMPA is seeking public input on a new regulation that allows the use of real-world data for the creation of a CER. Once adopted, real-world data becomes the potential resource to a huge volume of clinical evaluation reports. Real-world data refers to data from real medical cases rather than clinical medical trials, and could include information from registry databases, hospital electronic medical records, regional health care data, medical insurance data, health records, etc.
In April 2019, NMPA initiated the first research project, “Research on How to Apply Real-World Data in Clinical Evaluation of Medical Device Scientifically”, to be led by the Department of Medical Device Registration and Department of Medical Device Regulation, both under the umbrella of the CMDE (Center for Medical Device Evaluation).
The easily and rapidly accessible real-world data allows for the use of the EBM (Evidence Based Method) in the clinical evaluation of medical devices and avoids the need for lengthy clinical research. Once adopted, real-world data becomes the potential resource to a huge volume of CERs, and your product can be shipped quicker to the Chinese market.
In collaboration with Sichuan University, Zhejiang University, Peking University, and the Food and Drug Administration of Hainan, CMDE will explore the feasibility and methodology of applying real-world data for taking regulatory decisions. Also, the research project aims to find a solution to government reforms in the approval system of medical devices, as well as enhance the speed to market for new innovations.
If you have any opinions on the technical guidelines, keep in mind to submit them before the public consultation ends on 13.01.2020. Feel free to contact us for submissions on your behalf.
Download the English version of the Announcement
Download the English version of the Technical Guidelines