Update on China NMPA & US FDA Emergency Approval – Implications to Life Science Companies Relating to COVID-19
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 an unprecedented number of Emergency Approvals of medical devices, diagnostic assays, protective supplies, and sterilization tools. The first batch of diagnostic tests were 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 regulatory, clinical study conduct as well as quality assurance 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.
Upon conclusion of this webcast, you will:
- Learn about the products that have received NMPA latest emergency approval due to COVID-19
- Familiarize yourself with regulatory, clinical and quality assurance relevant regulations and conducts in both China NMPA and FDA
- Discover the urgently needed products in AI, diagnostics, ICU care, imaging, and more
- Understand the key implications to your market entry strategy