On 13.05.2020, various departments of the NMPA hosted a webinar with a representative from Allergan, the US global pharmaceutical company that was recently acquired by AbbVie Inc, another US company. Allergan’s glaucoma drainage tube was approved by the NMPA on 26.03.2020 to become the first imported medical device utilizing real-world data to register in China.
The webinar topic was real world data research and how to use real world data in registration applications.
The authorities and persons involved were: Mrs. Xuan HE (China Pharmaceutical News), Mrs. Hong LU (reviewer from CMDE), Mrs. Ning ZHU (Vice Director of Hainan MPA), Prof. Xin SUN (Director of The Chinese Cochrane Center), Mr. Lipeng WAN (RA Director, Allergan Shanghai), and Mr. Jun XU (China Health Media Group).
Apart from sharing their views on the application and transformation of real-world data in China, some clarifications were provided about the latest definitions of real-world data, real-world study/research, and real-world evidence applicable in China:
RWD (Real-world data) refers to the data derived from health care settings and sources other than traditional clinical trials to reflect the patients’ health status and the delivery of health care.
RWS/RWR (Real-world study/research) refers to the study and research of RWD on scientific topics and the comprehensive use of medical methods from epidemiology, biostatistics, evidence-based medicine, etc.
RWE (Real-world evidence) refers to the clinical evidence regarding the usage and potential risks / benefits of a medical product derived from the analysis of RWD.
During the registration process of Allergan’s glaucoma drainage tube, the NMPA also utilized the real-world data collected in Hainan’s Boao Lecheng International Medical Tourism Pilot Zone to evaluate ethnic diversity among patients.
Mr. Wan of Allergan Shanghai was asked about his registration experience using real-world data but declined to provide any details about the registration, other than that communication is important and their team is hardworking.
We have separately reported about the sharp increase in products applying to enter the Hainan Pilot Zone.
By Jacky Li. Contact Cisema to learn more.