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Measures for Supervision and Administration of Online Sales of Drugs: Analysis of Key Aspects and Impacts
Fast-growing e-commerce has changed lifestyles and invented new ways of consumption, amid which demand has rapidly increased for Internet-based medical services such as online drug sales and online medical diagnosis. Since the regulation and promotion of "Internet-based healthcare services" was included as part of the Outline of the "Healthy China 2030" Plan, China's Internet healthcare industry has been flourishing, channeled by a series of favorable policy decisions. In the meantime, buoyed by a boom in Internet hospitals and online diagnosis and treatment services, as well as a boost in prescription outflows and volume-based procurement of drugs, the online drug sales market is expected to expand unabated.
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Overview of China Drug Review Annual Report (2015-2021)
Since 2013, the National Medical Products Administration ("NMPA") Center for Drug Evaluation ("CDE") has been releasing a Drug Review Annual Report ("Report") each year, which summarizes its work on drug review of the previous year. The Reports have gradually covered key issues such as the acceptance of drug registration applications, the review and approval of drug registration applications, the expediting procedures, the communication mechanism, main issues on drug registration applications, the varieties in key therapeutic areas, and the review and approval of traditional Chinese medicines.
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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.
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Han Kun
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