China's State FDA Gets WHO Nod For Vaccine Regulatory System; Opens Global Market For Chinese Vaccine Makers
This article was originally published in PharmAsia News
Executive Summary
SHANGHAI - China's State FDA now complies with international standards for vaccine regulation and Chinese vaccine makers are eligible to apply for World Health Organization prequalification of vaccine products, WHO announced March 1, the same day that China implemented its newly revised good manufacturing practices (GMP) guidelines
You may also be interested in...
A Closer Look: With Only 60% Of China’s Sterile Drug Makers Passing New GMP Standard, What’s Next?
Only 60% of sterile drug manufacturers passed the new GMP standard in China, as smaller companies chose to quit the market.
China Releases New, Stricter Vaccine GCP Regulations
China FDA releases new vaccine good clinical practices regulations that detail responsibilities of sponsors, clinical research organizations, sites, investigators and ethics committees.
First Made-In-China Vaccine Gets WHO-Prequalification Setting The Stage For A New Global Player
China’s first World Health Organization prequalified vaccine marks a milestone in the country’s efforts to build on its massive internal demand. It also places the spotlight on other local vaccine producers that hope to repeat the success of the Chengdu Institute of Biological Products.