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  • Feature ArticlesFeature Articles

    Regulation of cell and gene therapy products in China

    This article provides an overview of the Chinese regulations and guidance documents for cell and gene therapy products (CGTPs).   Introduction As early as 1993, Chinese regulators provided guidance on clinical research for somatic cell and gene therapy. More regulations, laws, and guidances have since been published, either specific to, or including, CGTPs. The two most recent publications have been draft guidelines for clinical studies for immune cell therapy produc...
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    Regulatory Focus, August issue: Global clinical trials, clinical trial applications

    Feature articles during August focused on global clinical trials and clinical trial applications, with articles on regulatory options for conducting clinical trials in China, a case study on the impact of COVID-19 on submissions to European authorities, and an examination of Canada’s application process and alternate pathway for COVID-19‒related trials. Also included was an article on US Food and Drug Administration (FDA) updates on requirement for EUAs for diagnostics sup...
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    Initiating clinical trials in China: What foreign MedTech companies need to do

    This article discusses recent changes to clinical trial regulation in China. The author suggests that Chinese clinical trials for medical devices and in vitro diagnostic device (IVD) products are an increasingly viable option for non-Chinese companies of all sizes.   Introduction: China’s regulatory framework Most life sciences products sold in China, including medical devices and IVDs, are supervised by the National Medical Products Administration (NMPA), formerly k...
  • Feature ArticlesFeature Articles

    Current Chinese NMPA clinical pathways for medical device registration

    This article presents the key highlights of the current clinical pathways for registering medical devices in China and discusses when the various clinical pathways should be used, based on the country's National Medical Products Administration (NMPA) regulations and guidances. Introduction The NMPA, 1 formerly known as the China Food and Drug Administration, is the Chinese agency responsible for regulating drugs and medical devices. In addition to the national NMPA, ...
  • Feature ArticlesFeature Articles

    Update on trade issues affecting the dietary supplement industry

    This article discusses recent updates on US trade policy issues in the dietary supplement industry. It focuses on the trading relationship between the US and its largest trading partners, including China, and analyzes the ongoing effects of current trade policies on companies that produce, buy, and sell dietary supplements. The authors discuss tools available to US companies to reduce financial liability when trade policies are evolving at a rapid pace.   Introduction ...
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    FDA and China’s NMPA expedite COVID-19 emergency approvals

    In just a short time, the COVID-19 pandemic has dramatically changed the way we live and work, strained healthcare systems, and caused companies and governments to prioritize fighting the coronavirus above virtually all else. Regulators like the US Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) have moved to fast-track the review of products that might be used to prevent or treat COVID-19. Regulators Speed Up Review Times ...
  • Regulatory NewsRegulatory News

    Safeguarding the US Pharmaceutical Supply: Woodcock Discusses Challenges, Shift Overseas

    As drug and active pharmaceutical ingredient (API) manufacturing moves overseas to cut costs, quality and reliability concerns have been raised and the House Energy & Commerce Committee’s Subcommittee on Health met Wednesday to discuss the supply chain with one of the US Food and Drug Administration’s top officials and other experts. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, explained how part of the problem is that FDA does not know the...
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    China Joins IMDRF’s Safety Information Exchange Program

    China’s National Medical Products Administration (NMPA) has joined an International Medical Device Regulators Forum (IMDRF) program that allows for the rapid exchange of safety and adverse event data, according to reports from the IMDRF meeting in Russia last month. NMPA now joins regulators across Europe, Australia, Canada, Japan, Singapore and the US in the IMDRF National Competent Authority Report Exchange, according to a report from state media last month. The ...
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    FDA: US Heparin Supply Not Impacted by African Swine Fever in China

    With shortage concerns looming, the US Food and Drug Administration (FDA) on Monday said that the US heparin supply is not being impacted by the African swine fever in China. “The majority of manufacturers reported no such issues related to African swine fever,” FDA said after reaching out to heparin suppliers. “FDA continues to be in regular contact with US heparin suppliers and manufacturers as this situation evolves.” The update from FDA follows a letter sent in ...
  • RoundupsRoundups

    Asia Regulatory Roundup: China Releases UDI Rules as Pilot Progresses

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Seeks Feedback on Plan to List Excipients in Drug Products Online   Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on plans to list the excipients in medicines online. TGA is considering enforcing the change to give consumers access to information about the products they consume.   Today, the public version of the Australian Register f...
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    House Committee Seeks FDA Briefing on Heparin Supply

    The House Energy & Commerce (E&C) Committee leaders sent a letter on Tuesday to US Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless seeking further information on how FDA is monitoring the supply of the anticoagulant heparin. The letter notes how the US is reliant on China for its supply heparin, which in turn is reliant on China’s pig supply. Recently, China struggled to contain an outbreak of African swine fever and will lose about 150 million of i...
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    China’s NMPA Cites Overseas Device, IVD Companies

    China’s National Medical Products Administration (NMPA) published overseas inspection results in late January, highlighting 17 overseas medical device and IVD manufacturers that were cited, including BD and Boston Scientific.   Since November 2017, when NMPA began to publish overseas inspection results, a total of 41 manufacturers have been cited, according to ChinaMed Device, LLC, which is a medical device and IVD consulting firm based in Boston, and is a certified NM...