The National Medical Products Administration (NMPA) has released the “Drug Recall Management Measures,” which took effect on November 1, 2022. These measures outline the procedures for drug recalls, which refer to the withdrawal of marketed drugs by Marketing Authorization Holders (MAHs) due to quality issues or other potential safety hazards. MAHs are required to establish and improve drug recall systems, actively collect information related to drug quality and safety, investigate and evaluate potential issues, and carry out timely recalls. Pharmaceutical manufacturers, distributors, and users are required to assist in the recall process.
Classification of Drug Recalls
Drug recalls are categorized based on the severity of quality problems or potential safety hazards:
- Class I Recall: The drug may or has caused serious health hazards.
- Class II Recall: The drug may or has caused temporary or reversible health hazards.
- Class III Recall: The drug generally does not cause health hazards but needs to be withdrawn for other reasons.
Voluntary Recall Procedures
If an MAH determines through investigation and evaluation that a drug has quality issues or potential safety hazards, it must immediately decide and implement the recall. The recall information, including the drug name, specification, batch, holder, manufacturer, recall reason, and recall level, must be released to the public through the MAH’s official website or relevant media. For Class I or Class II recalls, the MAH must also publish the recall information on the website of the provincial drug regulatory department. Recall notices must be issued within specified timeframes: 1 day for Class I, 3 days for Class II, and 7 days for Class III recalls. Detailed records of the recall process must be kept for at least five years.
Mandatory Recall Procedures
If the drug regulatory department determines that an MAH should recall a drug but has not done so, or if the voluntary recall is deemed insufficient, the MAH will be ordered to conduct a recall. Within 10 working days of completing the recall, the MAH must submit a summary report to the relevant departments. The regulatory department will review the effectiveness of the recall within 10 working days and may request a re-recall if necessary.
International and Vaccine Recalls
If domestic MAHs find quality issues in exported drugs, they must notify the relevant authorities and purchasers. Overseas recalls must be conducted in accordance with the laws and regulations of the importing country and the procurement contract. The recall procedures for vaccines and traditional Chinese medicine items are also covered under these measures.-Fineline Info & Tech
