After thirteen years since China’s Measures for the Administration of Drug Recalls first came into effect, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) just proposed an updated version of its drug recall regulation for comments on October 10th.  The regulation follows the release of the updated statute Drug Administration Law of the People’s Republic of China (DAL) in 2019 and contains new language on the market authorization holder’s obligations during drug recalls that are largely consistent with the new DAL.  The timing is also of interest as NMPA has become more assertive recently in requesting international drug companies to conduct recalls in China when violations with Chinese laws and regulations are identified. 

Of most interest to the readers of this blog is the new requirement that even when a drug recall is initiated outside of China and does not involve the drugs marketed in China, the market authorization holder is still required to notify the Chinese authorities within 5 working days of the recall initiation.  This new provision is clearly intended to address concerns by some Chinese patients who believe that international companies are not attaching the same concern to the safety of Chinese patients as they do to patients in other regions.    

I am also highlighting a few other provisions in the proposal below that are significant. Comments to the proposal are due October 30, 2020.

• Article 4: Definition of “defective drug product” subject to recall.  The new regulation defines the term “defective drug product” as drugs that have quality problems or present potential safety concerns due to research and development, manufacturing, marketing, storage and transportation, and labeling.  In comparison, the current definition for the same term in the existing regulation does not reference “marketing, storage and transportation, or labeling.” 
• Article 9: Requirements for establishing drug traceability.  Market authorization holder, drug manufacturer, distributors, and users are now required to establish a drug traceability program.  While the provision contains no details on what the program should look like, at a minimum, the regulation requires all the sales record be retained. 
• Article 11: Drug recall information disclosure.  For a market authorization holder based outside of China, drug recall announcement shall be published on its Chinese website.
• Articles 12& 13: Market authorization holder shall proactively investigate and evaluate the potential defects with drug products.  Investigation of defective drug products shall include:

1. The type, scope and root cause of adverse events
2. Whether the current formulation and manufacturing process is consistent with the Chinese registration and whether the change controls are in compliance with China’s DAL and corresponding Chinese guidance
3. Whether the manufacturing of the drug complies with Chinese cGMP
4. Whether the marketing of the drug complies with corresponding quality control measures
5. Whether the use of the drug complies with the label
6. The target patient population
7. The batches that may pose safety concern, the scope and distribution
8. Other factors that may impact drug safety