News about GMP/cGMP

08.10.2021

PIC/S: China applies for PIC/S accession

PIC/S: China applies for PIC/S accession

The Chinese NMPA applied for PIC/S pre-accession on 24 September 2021. Although this stage is a voluntary assessment process, gaps are identified between PIC/S membership requirements and the system used by the regulatory agency that is interested.


First bilateral meetings between PIC/S and the NMPA date back to 2019. The pre-accession process by PIC/S will probably take up another two years. As a next step, the PIC/S Committee now nominates a Rapporteur and one or several Co-Rapporteurs, who will manage and oversee NMPA’s pre-accession process. As a follow-up, the PIC/S committee will subsdecide on next steps, e.g. an application for membership.

PIC/S beeing a non-binding, informal cooperative arrangement between regulatory authorities currently comprises 54 participating regulatory authorities all over the world. The latest accepted member was the Brazilian Anvisa in January 2021.


Source:

PIC/S: Newsroom


 

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