The World Health Organization (WHO) announced on March 1, 2011, that the national regulatory authority of China—the State Food and Drug Administration (SFDA), along with affiliated institutions—now meets WHO indicators for a functional vaccine regulatory system. This means that Chinese-made vaccines are now eligible to apply for WHO pre-qualification. On the same day as this WHO announcement, the China SFDA also adopted a new Good Manufacturing Practice code. The new code puts in place stricter requirements for vaccine production, in line with international standards, in order to ensure quality.
The announcement will motivate domestic manufacturers to strengthen vaccine development partnerships with international organizations at broader and more strategic levels. More government funding will also pour into companies working toward the goal of WHO pre-qualification. Furthermore, a new interest in vaccine technology will encourage Chinese scientists who are now working overseas to return to the country in order to leverage this opportunity.
Supported by BayHelix and hosted by Global Leaders Institute, world vaccine industry leaders will convene at VacChina 2011 on Nov 29 and 30 in Shanghai. The two-day executive summit will explore the major partnering opportunities in the vaccine industry in China. The goal of the summit is to bridge the China vaccine industry with the world class biotechnologies in terms of vaccine R&D and production. Key issues to be addressed:
• The requirements or the process of WHO pre-qualification, UNICEF procurement programs, or GAVI’s working mechanisms
• How to align China SFDA’s regulatory pathways and domestic clinical trials with international standards and requirements
• What do new Chinese Good Manufacturing Practice (GMP) standards and WHO approval for China’s vaccine regulatory system mean for China’s vaccine industry? Now that Chinese vaccine manufacturers can apply for WHO prequalification, will China take on a bigger role as a global vaccine supplier? Should we expect China to take a larger role developing novel vaccines?
• What kind of assistance do SFDA, CDC and Chinese manufacturers need from international partners (WHO, UNICEF, PATH, etc) to improve meet international standards? How will China respond to international concerns about quality and safety of Chinese vaccines?
• Novel approaches to cell culture to accelerate development and quality control
• How to improve cost and time to the clinic and ensure product quality through downstream processing
• Strategies to accelerate vaccine development process with the latest expression and characterization technologies