ince initiating the process of pre-accession to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in September 2021, the National Medical Products Administration (NMPA) of China has been actively participating in PIC/S-related activities and the progress has always been a focus of attention of the industry. In June 2023, a dedicated PIC/S symposium was held during the DIA China Annual Meeting where it was officially reported for the first time that NMPA’s pre-accession procedure has been successfully completed and NMPA will make a formal application for accession to PIC/S in 2023. This marks China’s active convergence with international standards to expedite the globalization process.

PIC/S is a nonbinding, informal cooperative arrangement between Regulatory Authorities in the field of good manufacturing practice (GMP) of medicinal products for human or veterinary use. PIC/S aims at harmonizing inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to inspectors. This is reflected in the PIC/S mission: to lead the international development, implementation, and maintenance of harmonized GMP standards and quality systems of inspectorates in the field of medicinal products.

The rapporteur of the NMPA’s pre-accession (Jacques Morenas) was pleased to state that after nearly two years of effort, NMPA’s pre-accession has been successfully closed for the Committee of Officials, and PIC/S is now waiting for NMPA’s formal accession application. One important point in the conclusion of pre-accession is that there are many different levels of authorities (national, provincial, and other levels) involved in the Good Manufacturing Practice Regulatory Compliance Programme (GMPRCP) in China, and therefore it is necessary to have them on board with NMPA when submitting an application to be a PIC/S participating authority. PIC/S and NMPA are reported to be in close contact for further steps.

For the formal accession, it is most important that the NMPA’s inspection criteria are equivalent with PIC/S’s. The PIC/S GMP regulatory compliance programme checklist is based on 11 components and 38 subcomponents comprising a total of 78 indicators.

• There are 8 subcomponents considered critical, 14 subcomponents considered very important, and 3 subcomponents considered important. (At the time the checklist was created, 13 subcomponents were combined with other similar subcomponents to facilitate the evaluation.)
• There are 48 indicators related specifically to the critical subcomponents, 26 for the very important subcomponents, and 4 for the important subcomponents.

Currently, the China Center for Food and Drug Inspections (CFDI) is working hard to conduct gap analysis between the Chinese GMP and PIC/S GMP. Given the differences in the legislative systems, it’s not so straightforward to conduct side-by-side comparisons without a comprehensive analysis. For example, veterinary drug requirements in PIC/S GMP Annex 4 and 5 are not applicable to NMPA’s GMP. Inhalation aerosol requirements are included in PIC/S GMP Annex 10, while in China, inhalation preparation requirements are issued via inspection guidance and not in a GMP Annex.

Upon completing this analysis, the CFDI will propose a plan for the revision of standards, including the Chinese GMP update scheme, to address these gaps. In addition, the CFDI has developed a national-level interpretation guide of the PIC/S audit checklist and organized specific training for provincial inspectors to conduct provincial-level self-assessments. All these efforts are aimed to achieve readiness and submit the formal accession request.

Harmonization of inspection requirements with international standards will impose higher requirements on industry, and participating in PIC/S would bring both challenges and benefits to industry as well. This impact may be different for companies which already supply products to PIC/S countries and those that do not. Typically, companies that are supplying a PIC/S market will already be subject to a regulatory inspection or a company audit, and quality systems and practices at these companies should already be aligned with PIC/S GMP expectations. Companies that are aligned to local GMP would typically prepare a gap analysis against old (local GMP) and new (PIC/S GMP) standards and establish a remediation and change plan to move to the new standard. Experts suggest that companies should take the initiative to review compliance strategy, make appropriate adjustments, and perform gap analyses, the sooner the better. Industry associations also play an important role to support training, capability building, etc., for smooth implementation.

Joining PIC/S is a long journey with a lot of efforts by various parties; the accession period lasts up to 6 years to allow harmonization of national inspection standards with the international ones. Since starting the pre-accession procedure in 2021, the NMPA has already made substantial progress, with the expected submission of an accession request in 2023. This would be another clear sign of NMPA’s determination and action to take China’s pharmaceuticals to the next level. All these efforts to modernize China’s GMP system are key to enhancing NMPA’s administrative capacity and improving industry’s quality management systems.