NMPA inspection rejection by Daewoong Bio Inc leads to import, sale and use suspension of Cefodizime Sodium for injection.
China’s NMPA announced its intention to conduct a dynamic on-site inspection of Cefodizime Sodium for Injection, a drug manufactured by DAEWOONG BIO INC. in Korea. The inspection formed part of the 2024 Overseas Inspection Plan for Drugs, which aims to ensure the quality and safety of pharmaceutical products imported into China.
The specific product in question:
- Product name: Cefodizime Sodium for Injection
- The Chinese registration certificate no.s: HJ20160445 and HJ20160446.
- Manufacturing location: 244, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea.
Daewoong Bio Inc. communicated in writing to the Chinese authorities that it could not accommodate the required on-site dynamic inspection. This refusal to comply with the inspection requirements constitutes a violation of both the Drug Administration Law of the People’s Republic of China and the Administrative Provisions on Overseas Inspection of Drugs and Medical Devices.
The NMPA has determined that the failure to undergo inspection renders the product non-compliant with Chinese regulatory standards. Consequently, under Article 99 of the Drug Administration Law and Article 30 of the Provisions on Administration of Overseas Inspection of Drugs and Medical Devices, the NMPA has taken the following actions:
- Immediate suspension of import, sale, and use: The importation, sale, and use of Cefodizime Sodium for Injection manufactured by DAEWOONG BIO INC. are immediately suspended. This action underscores the importance the Chinese authorities place on compliance with regulatory inspections to ensure the safety and efficacy of imported pharmaceutical products.
- Suspension of import customs clearance orders: The drug supervision and management departments at the ports of entry have been instructed to suspend the issuance of import customs clearance orders for this product. This means that the product will not be allowed to enter the Chinese market until further notice.
Recommendations:
Pharmaceutical companies with products registered in China should take this incident as a critical reminder of the importance of adhering to Chinese regulatory requirements, particularly regarding overseas inspections. Companies should:
- Ensure preparedness for inspections: Regularly review and update compliance protocols to ensure that manufacturing sites are always prepared for both scheduled and unscheduled inspections.
- Engage proactively with regulators: Maintain open lines of communication with Chinese regulatory bodies to address any potential issues before they escalate to suspension or other punitive actions.
- Monitor regulatory developments: Stay informed about changes in Chinese regulatory requirements such as annual NMPA inspection plans to ensure continuous compliance and minimize the risk of market access disruptions.
How can Cisema help?
Cisema has supported hundreds of overseas factory inspections by Chinese authorities across various product scopes and industries. If you would like specific advice about responding to NMPA inspections or other Chinese authority audit notices, or more general tips about best practices and frequently recurring overseas factory audit deficiencies, please contact us.
Further information
Read the original NMPA inspection announcement here.
Contact Cisema if you would like to learn more about our services for NMPA inspections.
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