SFDA Activates Special Procedures For Flu Vaccine Approval
This article was originally published in PharmAsia News
China's State FDA is putting in place special approval procedures to stockpile pandemic influenza vaccine before the Beijing Olympic Games opening. This is the first time that the country will enforce the procedure drawn up in 2005 to address emergency public health threats. Considering the supply urgency and the complexity of pandemic influenza vaccine R&D, SFDA is adopting an early intervention approach toward vaccine development. It has commenced approval procedures for the flu vaccine produced by Beijing Sinovac Biotech, and will complete the technical evaluation in the shortest possible time. The agency will then decide whether to issue the authorization certificate and drug approval number within three days. To date, Sinovac has finished Phase II clinical trial of its vaccine. (Click here for more - Chinese Language)
You may also be interested in...
From efficacy endpoints to patient warehousing, US FDA advisors weigh in on vaccine development and regulatory review.
Several years ago, heart device giant Edwards Lifesciences realized it needed a new CAPA framework that shifts corrective and preventive action from a one-size-fits-all method to a more nuanced approach. See what Dan Buehner, director of quality engineering at Edwards Lifesciences, said about it here.
FDA's recommendation that COVID-19 vaccine sponsors conduct two months of median follow-up to support an emergency use authorization may not be long enough, some experts say in what can be viewed as validation for agency's position in battle with White House.