Drug recalls in China now designate market authorization holders (MAH) as the key responsible entity, and have a revised regulatory framework according to the Measures for Drug Recalls (No. 92 of 2022) effective from November 1, 2022. Previously, manufacturers had the primary responsibility in managing drug recalls.
On October 26, 2022, the China National Medical Products Administration (NMPA) issued new administrative measures for drug recalls, which took effect on November 1, 2022. As compared with the previous version of the drug recalls framework issued in 2007, the new measures designate drug marketing authorization holders (MAHs), instead of manufacturers, as the main responsible entity for drug recall.
MAHs are required to establish the drug recall system, collect drug quality and safety information, investigate and evaluate potential quality issues and/or other safety risks, and recall the drugs with the issues and risks.
- A drug recall system manages the quality and safety risk hazards through post-market supervision. Withdrawing drugs from the market that may have potential risks to human health or taking corrective measures can minimize the potential adverse effects to the public and avoid greater harm caused to human health.
- The original drug recall management measures were issued by the former Food and Drug Administration in December 2007, and have been implemented for over ten years. In recent years, with the NMPA’s implementation of the newly revised Drug Administration Law and the newly enacted Vaccine Administration Law, the system concerning the MAHs has been put in place, and the requirements for drug regulation have changed significantly. In order to further reinforce drug quality supervision, enhance drug risk management, promote the implementation of the holder’s main responsibility, and ensure the safety of the public’s use of medicines, the new measures were formulated.
Scope of drug recall specified in the new measures
- Drug recalls refer to MAHs’ activities involved in withdrawing drug products with quality or safety issues from the market, and following prescribed procedures to take corresponding measures for risk control and eliminating hidden hazards in a timely manner. Quality and safety issues of medicines may be identified as not meeting the legal requirements in terms of research and development, production, storage and transportation, labeling and other reasons, or other unreasonable dangers that may render the medicines to endanger human health and life. Legal requirements include the current drug quality management norms, such as the Good Manufacturing Practice (GMP) and the Good Supplying Practice (GSP), and imperfect labeling instructions.
- Drugs seized or impounded by the drug supervision and management authorities under the provisions of the Drug Administration Law, and for which there is evidence that human health may be endangered, do not fall within the scope of recall under these Measures.
Type of drug recalls
- Active recalls are self-initiated by the MAHs. MAHs should collect information to investigate possible quality and safety issues with the drug product, and initiate recall actions if considered necessary. Drug manufacturers and related business enterprises and units shall provide the required support and assistance to the MAHs.
- Ordered recalls are ordered by the regulator. The drug regulatory departments at all levels shall perform corresponding regulatory duties. If the MAHs fail to complete the recall orders of drugs, the provincial medical products administrations (MPAs) may refer to the Pharmaceutical Administration Law to carry out prosecutions as appropriate.
How does the overseas holder implement the recall?
For drugs manufactured abroad, the NMPA Legal Agent designated by the overseas MAH shall fulfill the obligations to comply with the relevant drug recall measures and reporting requirements. The NMPA Legal Agent shall include the product name, specification, batch and reason for drug recall in the report submitted to the provincial MPA within 10 working days, if the overseas MAH initiates a drug recall outside of China and determines that it falls under either one of the following circumstances:
- The recalled overseas drug belong to the same product category of the drug marketed in China even if the product specification, batch, or dosage is different.
- The recalled overseas drug share the same production line of the drug marketed in China.
- There are other reasons considered necessary to report the the provincial MPA.
If the recall needs to be carried out in China, it shall be organized and implemented by the NMPA Legal Agent in accordance with these measures.
Whether recalled products can be re-listed
In principle, the recalled drugs cannot be listed again. However, by replacing the product label, modifying and improving the instructions for use, and through re-packaging and other ways to eliminate hidden risks, without affecting the safety and efficacy of the product itself, there is still a workaround solution for such products to re-enter the China market.
If you would like to know how we can support your drug product to comply with regulatory requirements in China, please contact us.