China’s National Medical Products Administration (NMPA) was granted by the PIC/S Committee, during its meeting on 6-7 November 2023, the status of Applicant to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The Chinese regulatory agency submitted its membership application on 22 September 2023, as a result of the successful completion and closure of the PIC/S pre-accession process.
The next phases of the procedure will be coordinated by the Rapporteur appointed by the PIC/S Committee, Jacques Morénas (France/ANSM), who will lead the PIC/S Audit Team in charge of managing and overseeing NMPA’s accession process. The NMPA will represent all Chinese authorities involved in the Chinese Good Manufacturing Practice Regulatory Compliance Programmes (GMPRCP) as defined by PIC/S.
Following confirmation of the Applicant status, NMPA will strengthen communication and cooperation with PIC/S. The final goal is to continuously improve China’s drug inspection system and standards, as well as its drug inspection quality management system. This is expected to support the development of Chinese inspectors’ team and the modernisation of the national drug regulation in China.