As COVID-19 has become a pandemic, the time is critical for the support and reassurance that science can offer.
In response to the outbreak, Chinese regulatory authorities adopted emergency measures to fast-track the review and approval process.
China NMPA (former CFDA) issued over 70 Emergency Approvals of medical devices, diagnostic assays, protective supplies, and sterilization tools. The first batch of diagnostic tests was approved within five days. Furthermore, multiple drugs and biologics are in a clinical trial and various stages of approval. One such example, Remdesivir — an antiviral drug that selectively inhibits the RNA-dependent RNA polymerase of the influenza virus — is a potential agent against COVID-19 and was approved within three days to enter a clinical trial.
During this 90-minute webcast, our experts will explain related guidelines, emergency approval procedures, urgent importations, how they work in practice, what is required during the COVID-19 crisis, and what to expect moving forward. You will gain an understanding of how these changes will impact market entry to both the US and China.
The topics will cover both China’s NMPA and US FDA regulatory updates. We will also discuss China’s evolving market dynamics that may impact manufacturers of medical devices, IVD, drugs, and biologics.
Yan Sheng, PhD, Project Manager, China Med Device, LLC
Lijun Xiao, Vice president of regulatory affairs at CR Medicon
Lijun Xiao has over 20 years of China NMPA drug and biologics regulatory and clinical affairs experience. As the vice president of regulatory affairs at CR Medicon. Xiao is a strategic advisor of early clinical development for many innovative drugs. She has had successful submissions of over 100 innovative drugs and biologics, IND and NDA for chemical drugs, biological products, and imported drugs from Amgen, Bayer, Novartis, and AstraZeneca.
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