Recently, the Chinese vaccine came good news one after another - On December 22, the "Healfor" hepatitis A inactivated vaccine produced by Beijing Kexing Biological Products Co., Ltd. was pre-certified by the World Health Organization The day before, December 21, the WHO issued a public notice in Geneva announcing the pre-certification of WHO viable oral divalent poliovirus vaccine (hereinafter referred to as 'bOPV') produced by China Bio-North Research Company.
In October 2013, the live attenuated Japanese encephalitis vaccine produced by the Chinese company Bio-Chengdu became the first Chinese vaccine that has been pre-qualified by the World Health Organization (WHO) and was pre-certified by WHO in 2015. The two A domestic vaccine almost simultaneously through the WHO pre-certification, both international organizations on the quality of our vaccine products to achieve international recognition, but also China's biological products to the international market an important milestone.
China's vaccine regulatory system has reached international standards
WHO pre-certification is an assessment of the quality, safety and efficacy of vaccine products to meet international standards, and the pre-qualification of vaccine products to be pre-qualified by WHO has the precondition that the country's vaccine regulatory system pre- Approved by WHO.
In 2011, the high score of China's vaccine regulatory system was assessed by WHO, and under the higher assessment standards, it passed the WHO reassessment in 2014. This indicates that our vaccine regulatory system has reached international standards and has the capability of continuously improving the regulatory level .
China's vaccine regulatory system through the WHO assessment means that the domestic vaccine manufacturers have the qualifications for WHO vaccine pre-certification, which is equivalent to open the door of domestic vaccine products to enter the international market, which is bigger and stronger for China's vaccine industry to enhance industrial competitiveness has great significance.
Full life-cycle regulation ensures vaccine quality and safety
Statistics from the State Food and Drug Administration show that at present, China is the largest vaccine producer in the world with more than 40 vaccine manufacturers, accounting for more than 95% of the actual vaccination volume in China. The number of domestic vaccines not only satisfies Domestic vaccination needs, but also for export to international organizations for procurement. Each year UNICEF and other international organizations to purchase our vaccine for the vaccination of children in other developing countries. China has established a cover vaccine 'R & D - production - circulation - vaccination' of all life Cycle of the regulatory system.
Vaccines are widely used, especially for children and infants, and thus have higher requirements for their safety and efficacy.In order to ensure the quality of vaccines, WHO proposes six functions of national vaccine regulation. Among them, the "batch issuance" is the last before vaccine launch A key point is one of the important regulatory measures to ensure the safety and effectiveness of vaccines. It is a universal requirement for vaccine regulation in the world.
As of January 1, 2006, China has implemented the batch issuance of all vaccines listed, that is, each batch of vaccine products manufactured or listed at the time of mandatory inspection, audit. Inspection failed or not approved, shall not be listed Or import.
The 2016 Annual Biologics Batch Issue Report released in July 2017 shows that in 2016, China issued 51 batches of vaccines and 3949 batches, accounting for about 646 million doses. Since the implementation of the batch issuance system in our country, the system has been continuously improved and continuously improved , Approved the production of the product specification is better, the quality is stable and controllable.
In 2013, given the outstanding achievements in the field of quality control and standardization of vaccines and biological products, WHO has rigorously evaluated the WHO expert group to make our country a WHO collaborating center for the standardization and evaluation of biological products, which not only enables our country to participate more deeply in international biological product standards Formulate work and get more voice, but also shows that the overall vaccine regulatory in China reached the world advanced level, is conducive to promoting China's vaccine quality standards to further enhance.
In order to further ensure the quality and safety of listed vaccines, the food and drug regulatory authorities regularly supervise and test the listed vaccines every year, and randomly select samples from the market circulation to test the quality of the vaccines. Since 2007, China has included vaccine products under the supervision of high-risk products, The establishment of professional full-time inspectors team, every year to track the way vaccines manufacturers to cover the full coverage of the production site inspection.
China's vaccine to the world interpretation of 'big country play'
In recent years, along with the accelerating pace of the reform of China's drug review and approval system, the drug registration process, technical requirements, clinical trials and other aspects are in line with the international advanced level.In this environment, the quality of our vaccines continued to improve, vaccine companies Increasing international competitiveness. 'Domestic vaccine production technology has been very mature, production technology and quality standards gradually with the international standards, the output is relatively stable.' Peking University School of Public Health Associate Professor Cui Fuqiang told reporters.
The official of China's Biological Department said that the domestic vaccine products 'going out' are the pragmatic practices of local pharmaceutical companies in implementing the 'One Belt and One Road Initiative' in an all-round manner and carrying out international exchange and cooperation in infectious disease prevention and control. The completion of the strategic plan for the final phase of the global eradication of poliomyelitis is of great importance.
This reporter has learned that at present, there are 37 countries or regions in the world to list hepatitis A vaccine in the list of national immunization programs.
Beijing Kexing independent research and development of China's first hepatitis A inactivated vaccine (commodity name: child Erfu), is the largest dose, the most complete clinical research of hepatitis A inactivated vaccine, is also the world's second, China's first through the WHO Pre-certified hepatitis A vaccine.
"It is of great and far-reaching significance that Childflow pre-certifies through WHO - products can enter the procurement platform of international organizations. Currently, Childflow is registered in over ten countries in Asia and South America and will Under the guidance of our "One Belt and Road Initiative", we will supply more countries and regions. "According to Meng Weining, Beijing Kexing International Registrar,
Experts predict that with the continuous introduction of new vaccines and the continuous improvement of vaccine regulatory capacity in our country, more and more high-quality domestic vaccines will be pre-certified by WHO to enter the international market and take this as an opportunity to promote the comprehensive upgrading of China's pharmaceutical industry , The quality of medicines has been improved.
