Vaccine independently developed in China has been pre certified by who for the first time

  The reporter learned from the State Food and Drug Administration on September 9 that the World Health Organization announced in Geneva that China's independently developed "live attenuated encephalitis B vaccine" (hereinafter referred to as live encephalitis B vaccine) has passed the pre certification of the World Health Organization (hereinafter referred to as who) and entered the drug purchase list of the United Nations procurement agency, which has become a breakthrough in the history of vaccine development in China Japanese encephalitis is a serious infectious disease transmitted by mosquitoes It is a major public health problem in the world It is highly prevalent in China, the southeast of the Russian Federation, South Asia and Southeast Asia, with a seasonal distribution, with a high rate of disability and even death Because there is no effective treatment plan, vaccination has become the most effective way to prevent the epidemic of the disease It is understood that vaccine pre certification is an assessment and certification work carried out by who to ensure that the quality, safety and effectiveness of vaccine products meet international standards, providing "pass" for vaccine procurement of United Nations procurement agencies The "live attenuated Japanese encephalitis vaccine" independently developed by China Pharmaceutical (600056, Guba) it is produced by Chengdu Institute of biological products, affiliated to China Biotechnology Co., Ltd of the group Since the start of the WHO pre certification project in 2006, this research unit has invested nearly 800 million yuan in the construction of hardware facilities and management system related to live JE vaccine, and finally obtained the certification breakthrough after 7 years The advantages of quality, production capacity and price of the vaccine product will also provide strong support for children in developing countries to avoid the harm of JE According to the data, in March 2011, the State Food and Drug Administration passed the functional evaluation of who national regulatory agencies In November 2012, the Institute became the WHO vaccine pre certification contract laboratory, and in January 2013, the WHO designated the Institute for biological product inspection (ibpc) of nifdc as the WHO biological product standardization and evaluation Cooperation Center (WHOCC) This provides guarantee for China's vaccine to enter the international market, as well as the long-term quality standard research and quality control of vaccine "The vaccine made in China has become a who pre certified product, which is a new progress in protecting children from JE in developing countries and in the future, the vaccine will be more widely available, which will benefit the whole world," said Margaret Chan, director general of who The State Food and Drug Administration said it will continue to improve its regulatory capacity, strengthen various regulatory measures, encourage, support and guide enterprises to develop and produce, and through the WHO pre certification platform, let more high-quality drugs that meet international standards enter the international market, so as to promote the overall improvement of China's drug industry and drug quality Recommended reading: 2013 animal vaccine development forum