China’s Coronavirus Vaccine Ambition Hampered By Lack Of Guidance On Overseas Clinical Data
Global Objectives Meet Local Regulatory Murkiness
As two Chinese-developed vaccines against COVID-19 enter the final stage of testing in Latin America and the Middle East, a lack of guidance on using data obtained outside China could potentially pose challenges to regulatory approvals at home.
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Brazil’s medicines regulator has published advice for developers on how to proceed with ongoing clinical trials and bioequivalence studies during the current COVID-19 pandemic.
Chinese state-owned company Sinopharm has started a Phase III coronavirus vaccine study in Abu Dhabi, while another Chinese firm, Sinovac, has commenced its trial with partner Butantan in Brazil. Meanwhile, regulators in Beijing have started an audit process to ensure regulatory compliance.
Guidance on COVID-19 vaccine development and licensure appears to set a precedent in specifying the clinical efficacy rate for a product approval; agency also takes accelerated approval off the table for now and says emergency use authorization may be granted only after safety and efficacy have been demonstrated.