On July 27, the Department of Drug Regulation of the NMPA holds a meeting in Kunming, Yunnan province to promote accession to the Pharmaceutical Inspection Co-operation Scheme(PIC/S). The meeting overviews NMPA current progress of applying for PIC/S accession since this year, analyzes the results and common issues of each provincial-level medical products administration based on their self-assessment on par with the requirements, circulates the comparative analysis between the domestic GMP and the PIC/S GMP Guide, further deploys tasks for the next phase and clarifies the working requirements.

The meeting invites experts from the Department of Health, Hong Kong SAR to explicitly introduce detailed conditions of application documents and specific procedures of on-site evaluation when Hong Kong SAR applying for PIC/S accession, as well as the current situation of drug regulatory system construction and drug inspection in Hong Kong SAR. Officials from the Center for Food and Drug Inspection (CFDI) of the NMPA and provincial-level medical products administrations introduced PIC/S Quality System Requirements for Pharmaceutical Inspectorates, PIC/S Risk-Based Inspection Planning and Guidance on Classification of GMP Deficiencies, Quality Risk Management (ICH Q9) guideline, and the construction of a professional and specialized inspector team based on their work experience. The meeting also invites experts to share the comparative study and implementation experience on the PIC/S annex of sterile medicinal products.

The meeting emphasized that provincial-level medical products administrations should enhance their political stance and fully recognize the significance of joining PIC/S in reinforcing the drug inspection capabilities and promoting the standardization and internationalization of drug regulation in China. The meeting requires all relevant institutions to focus on key tasks, strengthen work collaboration, and make every effort to prepare application documents; Each provincial-level medical products administration, in accordance with the deployment of the NMPA, should continuously improve the mechanism for drug inspection, persistently optimize the quality management system of drug inspection, take this opportunity to steadily promote the construction of the drug inspector team and enhance the modernization of drug regulation.

The head of the Department of Drug Regulation of the NMPA, the leaders of CFDI and China Center for Food and Drug International Exchange, and relevant responsible persons of NMPA special team for PIC/S accession attend the meeting. The heads of key provincial-level medical products administrations, and directors of manufacturing regulation divisions and heads of drug control institutions of provincial-level medical products administrations also attend the meeting.