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On August 23, the World Health Organization (WHO) officially announced that China has passed the National Regulatory Authority (NRA) assessment for vaccines
Since 2006, the WHO will use the vaccine NRA assessment as a precondition for purchasing the country's vaccine products, that is, only if the country passes the assessment, the country's enterprises can apply for WHO vaccine product pre-certification and be included in the procurement list
of international organizations such as the United Nations.
In addition, passing the WHO-PQ (Pre-qualification, pre-certification) is also an important reference for other countries to register and purchase vaccine products from
other countries.
Through the NRA assessment, on the one hand, it means that China's vaccine regulatory system is benchmarked against international standards, the vaccine quality management system meets international standards, China can ensure the safety, effectiveness and controllable quality of vaccine products, on the other hand, it also creates good conditions for China's vaccine products to export to the world and help the development of the world's public health cause, and China can play a more active role in global vaccine supply and contribute to promoting the accessibility and affordability of vaccines in the world, especially developing countries
。
It is understood that since China's first vaccine NRA evaluation in 2011, China's domestic Japanese encephalitis live attenuated vaccine, type I III polio live attenuated vaccine, hepatitis A inactivated vaccine and other 7 vaccines have passed the WHO vaccine pre-certification, entered the international procurement list, by UNICEF, the Global Alliance for Vaccines and Immunization and other international institutions procurement, related vaccine products have been exported to dozens of countries and regions
。 Since the outbreak of the new crown pneumonia epidemic, China has 3 new coronavirus vaccines included in the WHO emergency use list, and Chinese vaccines have been exported and supplied to hundreds of countries and regions around the world, playing a greater role
in the global "war epidemic".
In recent years, with the continuous acceleration of the modernization of China's drug supervision, the acceleration and improvement of the drug management regulatory system, the gradual deepening of the scientific development of smart supervision and supervision, the acceleration of the upgrading of drug supervision capabilities, and the entry of China's pharmaceutical industry into the fast lane of high-quality development, effective and accessible to
the people's medication has been effectively guaranteed.
It is reported that China will continue to fully implement the "four strictest" requirements, actively benchmark international standards, continuously improve regulatory capabilities and levels, improve vaccine production and circulation supervision, strengthen adverse reaction monitoring, strengthen batch issuance risk management, etc.
, implement the whole process, the whole link, all-round strict supervision of vaccines, further promote the improvement of China's vaccine quality, protect the people's drug safety, and promote China's transition from a vaccine power to a vaccine power
.
The construction and improvement of the national regulatory system for vaccines is only carried out when it is carried out, not when it is
completed.
The head of the NRA office said: "We will take this assessment as a new starting point, continue to communicate and cooperate closely with the WHO, work together with all relevant departments, continuously improve the ability and level of drug supervision, continue to provide safe and effective, controllable and affordable vaccine drugs for Chinese and the global public, and make greater contributions
to the protection and promotion of human health.
" ”
Since 2006, the WHO will use the vaccine NRA assessment as a precondition for purchasing the country's vaccine products, that is, only if the country passes the assessment, the country's enterprises can apply for WHO vaccine product pre-certification and be included in the procurement list
of international organizations such as the United Nations.
In addition, passing the WHO-PQ (Pre-qualification, pre-certification) is also an important reference for other countries to register and purchase vaccine products from
other countries.
Through the NRA assessment, on the one hand, it means that China's vaccine regulatory system is benchmarked against international standards, the vaccine quality management system meets international standards, China can ensure the safety, effectiveness and controllable quality of vaccine products, on the other hand, it also creates good conditions for China's vaccine products to export to the world and help the development of the world's public health cause, and China can play a more active role in global vaccine supply and contribute to promoting the accessibility and affordability of vaccines in the world, especially developing countries
。
It is understood that since China's first vaccine NRA evaluation in 2011, China's domestic Japanese encephalitis live attenuated vaccine, type I III polio live attenuated vaccine, hepatitis A inactivated vaccine and other 7 vaccines have passed the WHO vaccine pre-certification, entered the international procurement list, by UNICEF, the Global Alliance for Vaccines and Immunization and other international institutions procurement, related vaccine products have been exported to dozens of countries and regions
。 Since the outbreak of the new crown pneumonia epidemic, China has 3 new coronavirus vaccines included in the WHO emergency use list, and Chinese vaccines have been exported and supplied to hundreds of countries and regions around the world, playing a greater role
in the global "war epidemic".
In recent years, with the continuous acceleration of the modernization of China's drug supervision, the acceleration and improvement of the drug management regulatory system, the gradual deepening of the scientific development of smart supervision and supervision, the acceleration of the upgrading of drug supervision capabilities, and the entry of China's pharmaceutical industry into the fast lane of high-quality development, effective and accessible to
the people's medication has been effectively guaranteed.
It is reported that China will continue to fully implement the "four strictest" requirements, actively benchmark international standards, continuously improve regulatory capabilities and levels, improve vaccine production and circulation supervision, strengthen adverse reaction monitoring, strengthen batch issuance risk management, etc.
, implement the whole process, the whole link, all-round strict supervision of vaccines, further promote the improvement of China's vaccine quality, protect the people's drug safety, and promote China's transition from a vaccine power to a vaccine power
.
The construction and improvement of the national regulatory system for vaccines is only carried out when it is carried out, not when it is
completed.
The head of the NRA office said: "We will take this assessment as a new starting point, continue to communicate and cooperate closely with the WHO, work together with all relevant departments, continuously improve the ability and level of drug supervision, continue to provide safe and effective, controllable and affordable vaccine drugs for Chinese and the global public, and make greater contributions
to the protection and promotion of human health.
" ”
