The National Medical Products Administration (NMPA) has released a notification regarding the initiation of electronic certificates for biologic product releases and electronic approvals of narcotic drugs, as well as the establishment of a psychotropic substances study program. These measures aim to streamline regulatory processes and enhance efficiency in the management of biologic products and controlled substances.
Electronic Licenses Implementation
Electronic licenses for biologic products and narcotic drugs will be issued starting from November 1, 2022. Once implemented, a successful notification push will be considered a delivery, and in principle, no paper licenses will be issued. These electronic licenses carry the same legal effect as paper certificates and come equipped with features such as instant delivery, SMS reminders, license authorization, code scanning queries, online verification, and online sharing.
Registration and Access
Applicants are required to initially register with real-name verification at the NMPA’s official website https://zwfw.nmpa.gov.cn/web/index and maintain relevant account numbers, electronic certificates, and electronic approvals. Applicants can check and download their electronic licenses on the NMPA website or via the NMPA APP.
Future Outlook
The introduction of electronic certificates and approvals underscores the NMPA’s commitment to modernizing regulatory processes. By leveraging digital technologies, the NMPA aims to enhance transparency, reduce administrative burdens, and improve the overall efficiency of regulatory oversight in the biologic and controlled substances sectors.-Fineline Info & Tech
