Skip to main content Skip to search Skip to main navigation

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

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

Swissmedic Updates Guidance on GMP Compliance of Foreign Manufacturers

Swissmedic Updates Guidance on GMP Compliance of Foreign Manufacturers

Swissmedic has revised its guidance document “GMP compliance by foreign manufacturers”. The new Version 7.0 has been valid since 7 September 2026. In particular, it introduces new provisions for demonstrating the GMP compliance of manufacturers inspected by the US FDA. 
Read more
Swissmedic Updates Requirements for Cooperation with Pre-Wholesalers

Swissmedic Updates Requirements for Cooperation with Pre-Wholesalers

Swissmedic has revised its Technical Interpretation “Market release and distribution in cooperation with a pre-wholesaler”. The document addresses market release and distribution where a Marketing Authorisation Holder works with a pre-wholesaler (logistics and distribution service provider).
Read more
News: Europe

IPEC Updates Two Guides on Pharmaceutical Excipients

The IPEC Federation has updated two key guides on pharmaceutical excipients. The IPEC Composition Guide for Pharmaceutical Excipients (Version 3, 2026) describes an approach for manufacturers to establish excipient composition profiles. The revised version now covers biotechnology- and fermentation-derived excipients, provides further details on component types and physicochemical characterisation, and includes an example composition profile template.
Read more
Applying the FDA’s 7-Step Model for AI/ML Validation in GMP Environments: One Year Later

Applying the FDA’s 7-Step Model for AI/ML Validation in GMP Environments: One Year Later

Artificial intelligence is becoming increasingly important in GMP-regulated environments, presenting companies with new regulatory challenges. This article summarizes the latest regulatory developments, introduces a validation framework based on the FDA's seven-step model, and outlines initial practical experience with AI/ML validation.

Read more
Question of the Week | GMP-Verlag

What are the General Requirements for Standard Documents?

Here's the answer:
Read more
News: Europe

EDQM: Revised Guidance on Sister File Applications

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has revised its Guidance on applications for “sister files” (PA/PH/CEP (09) 141). The revision is intended to support consistent application of the procedure and provide greater clarity on the classification and assessment of the corresponding CEP applications.
Read more
Previous
Next