On October 10, thirteen years after China’s Measures for the Administration of Drug Recalls first took effect, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) proposed an updated version of its drug recall regulation. 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 notable, as NMPA has recently become more assertive in asking international drug companies to conduct recalls in China when violations of Chinese laws and regulations are identified. Comments on the proposed regulation are due October 30, 2020.

Most notable in the proposal is the new requirement that when a drug recall is initiated outside of China and does not involve the drugs marketed in China, the market authorization holder will be required to notify Chinese authorities within 5 working days of initiating the recall. This new provision seems intended to address concerns by some in China that international companies are less concerned about the safety of Chinese patients than they are with regard to patients in other countries.

Other significant provisions in the proposal include:

• Article 4: Definition of “defective drug product” subject to recall. The new regulation defines the term “defective drug product” as a drug that has quality problems or presents potential safety hazards due to research and development, manufacturing, marketing, storage and transportation, or labeling. This reflects an expansion of the definition, which currently does not include safety hazards due to “marketing, storage and transportation, or labeling.”

• Article 9: Requirements for establishing drug traceability. Market authorization holders, drug manufacturers, distributors, and users are now required to establish a drug traceability program. Although the provision contains no details on what the program must contain, it does, at a minimum, require companies to retain all sales records.

• Article 11: Drug recall information disclosure. A market authorization holder based outside of China that recalls a product must publish the drug recall announcement on the company’s Chinese website.

• Articles 12 & 13: Market authorization holders must proactively investigate and evaluate potential drug product defects, with the investigation including attention to:

  • The type, scope, and root cause of adverse events;

  • Whether the current formulation and manufacturing process are consistent with the registration, and whether the change controls are in compliance with the DAL and corresponding Chinese guidance;

  • Whether the manufacturing of the drug complies with Chinese cGMP;

  • Whether the marketing of the drug complies with corresponding quality control measures;

  • Whether the use of the drug complies with the label;

  • The target patient population;

  • The batches that may pose safety concerns, as well as their scope and distribution; and

  • Other factors that may impact drug safety.

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