NMPA overseas factory inspections and audits have restarted in earnest. Cisema knows of at least three medical device manufacturers notified by the authorities this week alone for NMPA inspections. Together with recent official announcements this shows that such overseas audits, long dormant due to covid restrictions, are returning. Companies should be prepared for such audits and know what to do when receiving a notice from the NMPA. Read on to know the key points.
NMPA overseas factory inspection regulations
In response to the State Council’s directives on enhancing overseas inspections of imported medical devices and pharmaceuticals, the National Medical Products Administration (NMPA) has introduced the “Regulations on Overseas Inspection Management of Pharmaceuticals and Medical Devices” on December 28, 2018. The NMPA aimed at broadening the scope of inspections to include not only local production facilities but also overseas sites abroad with referencing to international standards.
The regulation delineates procedures for handling inspection findings, distinguishing between risk mitigation measures and investigative actions. Serious quality risks identified during inspections trigger immediate risk control actions, with the possibility of removal upon risk mitigation. Instances of suspected illegal activities uncovered during inspections prompt lawful investigations. This regulatory framework aligns China’s oversight of overseas pharmaceuticals with international norms, bolstering safety measures while promoting compliance within the industry.
How to be ready for overseas factory audits?
From Cisema’s experience advising and supporting international manufacturers across a diverse array of industries for overseas factory inspections, the following key points should be addressed:
- clear coordination and planning of the audit schedule with NMPA;
- smooth facilitation of arrangements such as obtaining the auditor’s visa, arranging accommodation and meals for the auditor at the factory, and managing communication and coordination between the auditor and the local factory once NMPA provides the Site Master File (SMF);
- awareness and sensitive addressing of language barriers and cultural differences, like food preferences, appropriate communication channels, terminologies;
- interpretation and coordination between all parties during the on-site audit;
- obtaining the final audit report from NMPA; and
- rectifying and clearly addressing any non-conforming items identified during the audit.
This includes having proficient translators with expertise in QA/RA/R&D and relevant device backgrounds as the NMPA overseas factory inspections are typically conducted in Chinese. Advance preparation should include gathering necessary documents, carrying out mock inspections, and on-site training.
Comparing NMPA to EU and US factory inspections
Due to the nearly five year gap during which NMPA has not conducted overseas factory inspections and audits, companies may need some reminding about differences from their usual experiences of EU and US factory inspections. Some items to consider from our experience follow.
- Team Composition: NMPA inspections typically involve a larger team with three or more inspectors and possibly additional observers working in parallel. This requires adequate translators and moderators to be present onsite.
- Expertise: The NMPA inspection team is not only composed of GMP inspectors but also includes technical file reviewers, testing engineers, and other specialists. They are supported by a larger team at the headquarters, which can be consulted for clarifications on complex issues.
- Evidence Collection: NMPA inspectors may take photos or videos during the inspection to serve as evidence.
- Sample Testing: Inspectors may collect samples themselves or request manufacturers to send them to NMPA for further analysis.
Case studies
During the restrictions brought about by the pandemic, remote inspections by NMPA became the norm. Here are some recent case studies of adverse audit findings by NMPA.
In May 2023, based on the findings from a remote inspection, the NMPA suspended the importation, operation, and usage of Allogeneic Bone Repair Material from South Korea’s Hanshisei Life Science Corporation.
In accordance with the regulations on overseas inspection management of pharmaceuticals and medical device, the NMPA has decided to authorize the resumption of sales and usage of Quetiapine Fumarate produced by Dr. Reddy’s Laboratories Ltd from April 20, 2023, onwards, after being suspended in September 2018. Upon conducting technical evaluations, the NMPA concluded that the post-correction product complied with China’s production quality management standards.
On September 19, 2023, the National Medical Products Administration conducted a remote non-site inspection of the Pelvic Organ Prolapse Repair System produced by Prestige Medicare Co., Ltd., a company based in South Korea. Following a comprehensive assessment, it was determined that the product did not meet the relevant regulatory requirements in China. Consequently, the National Medical Products Administration has decided to suspend the importation, operation, and usage of the Pelvic Organ Prolapse Repair System manufactured by Prestige Medicare Co., Ltd., effective immediately.
The regulatory measures underscore the NMPA’s commitment to ensuring the safety and quality of imported medical devices and pharmaceuticals through rigorous inspection protocols and regulatory actions.
How can Cisema help?
Cisema has supported for hundreds of overseas factory inspections by Chinese authorities across various product scope and industries. If you would like specific advice about responding to NMPA or other Chinese authority audit notices, or more general tips about best practices and frequently recurring overseas factory audit deficiencies, please contact us.
Contact Cisema if you would like to learn more about our services for NMPA overseas factory inspections.
