NMPA Revised Measures for Medicinal Product Recalls
ISSUING AUTHORITY:
National Medical Products Administration
DATE OF ISSUANCE:
October 24, 2022
EFFECTIVE DATE:
November 1, 2022
On October 24, 2022, the National Medical Products Administration (NMPA) issued the revised version of the Measures for the Administration of Medicinal Product Recalls (the “New Measures”), which came into force on November 1, 2022. The New Measures specify that the market authorization holder (MAH) is primarily responsible for recalling drugs that have quality problems or other potential safety hazards. The drug manufacturers, distributors and users shall actively assist and cooperate with the MAH in fulfilling the recalling obligation.
It is worth noting that compared to the Measures for the Administration of Medicinal Product Recalls implemented on December 6, 2007, the New Measures have added specific requirements for overseas MAH in the event of a recall of a drug outside of China. Where an overseas MAH conducts a recall of a drug marketed abroad, the domestic agent of the relevant domestically marketed drug has the obligation to report the recall information to the provincial drug administration under the following circumstances: (1) where the drug marketed abroad is of the same type as the drug marketed in China, but does not involve the specifications, batch, or dosage form of the domestic drugs; (2) where the drug marketed abroad shares a production line with the drug marketed in China; or (3) any other circumstance that needs to be reported to the drug administration.
The MAH shall specify the labeling of and storage requirements for recalled drugs, and clearly differentiate them from normal drugs to prevent errors and confusion. If the recalled drugs need to be destroyed, they shall be done under the supervision of the MAH, the drug manufacturer, the drug administration or a notary authority. The MAH shall keep a detailed record of the treatment of recalled drugs, and the record shall be kept for five years and not less than one year after the expiration date of the drugs.
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