- Download 2
- File Size 0.00 KB
- File Count 1
- Create Date April 8, 2020
- Last Updated January 6, 2022
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.