Highlights on the New Drug Recall Regulation of 2022
On October 26, 2022, the National Medical Products Administration ("NMPA") issued the newly revised Measures for the Administration of Drug Recalls ("the 2022 Measures") that has just been formally adopted. The former Measures for the Administration of Drug Recalls ("the 2007 Measures") was issued and implemented on December 10, 2007. Since then, the Drug Administration Law has been amended several times, and the Marketing Authorization Holder (MAH) system was officially implemented in 2019. As a result, the 2007 Measures needs to be amended so that it can align with the current Drug Administration Law. On October 13, 2020 and September 26, 2021, NMPA has released two drafts for comments of the Measures for the Administration of Drug Recalls ("Draft for Comments") respectively, and has officially adopted the 2022 Measures on October 24, 2022. The 2022 Measures is effective since November 1, 2022. This article will summarize some important modifications in the 2022 Measures compared with the 2007 Measures.