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Chinese Vaccine Regulatory System Has Passed the WHO Evaluation

Mar. 1st, 2011, the State Food and Drug Administration (SFDA) held Teleconference and Television Summary Meeting in Beijing for Chinese Vaccine Supervision Complying with World Health Organization (WHO) Standards. Mr. Shao Ming-li, Director of SFDA, Dr. Yin Li, Deputy Minister of Health, Mr. Wu Zhen, Deputy Director of SFDA, Dr. Michael O' Leary, Chief of WHO China and Dr. Lahouari Belgharbi, a scientist of the WHO Department of Immunization, Vaccines and Biologicals.


China's national regulatory authorities, represented by the State Food and Drug Administration (SFDA), in the area of vaccines were recognized by WHO as "functional," said Lahouari Belgharbi in this conference. "Chinese manufacturers can submit applications to have their vaccine prequalified by WHO". Belgharbi headed a WHO group to conduct the latest assessment last December, examining the performance of SFDA with regard to vaccine regulation. He specifically looked at the SFDA's overall regulatory framework, marketing authorization and licensing, post-marketing surveillance, and especially the adverse reactions to immunization.


China is the 36th vaccine producing country that has had its regulatory system assessed as qualified by the WHO, he said. "It is a validation of the capability of the Chinese regulatory authority..." said WHO China Representative Dr Michael O'Leary. With a regulatory system for vaccines documented to comply with international standards, vaccine manufacturers in China are now eligible to apply to WHO for prequalification of vaccines, O'Leary told the conference.


For the evaluation of WHO, since July, 2009, SFDA formulated a unified "route map", with careful organizing, and effective implementation. To comprehensively improve the vaccine quality supervision system for the critical factors, guide local manufacturers to improve their quality management system, SFDA proactively revised and released an new GMP criteria, laid the foundation for successfully admitted by the evaluation and therefore display the authentic level and situation of Chinese drug supervision and administration.


During Dec. 13th-17th 2010, WHO initiated an official five-day inspection to SFDA. The experts from WHO HQ, WHO Chinese office, Food and Drug Administration, the French Health Food Hygiene Bureau and other institutions comprehensively assessed the Chinese vaccine regulatory system. Simultaneously dispatched several teams to inspect Shanghai, Jiangsu, Hebei provincial SFDA offices for the overall assessment to AEFI, clinical trial supervision and others. The evaluation showed that 2 parts get full scores, and the other 5 parts are also very good, applying for the WHO criteria.


Passing WHO evaluation is an important step for improving our vaccine industry, enhancing its global competitiveness. China is an un-separable part of global vaccine manufacture; there are more than 30 vaccine manufacturers in china and the annual capacity is nearly 1 billion dosages. Passing the WHO evaluation means that Chinese vaccine enterprises can apply their vaccine for WHO prequalification, the pre-qualified products can be purchased by other countries and regions through United Nations Channel. Recently, SFDA has invited WHO experts to train and guide the enterprises that prepared for submitting their vaccine for WHO prequalification, which support and guide enterprises to actively participate the international competition and enter into the international market.


Dr. Lahouari Belgharbi also said China may become one of the major suppliers of affordable vaccines in next one or two years, and Chinese exportation of its vaccines, will contribute to the National Immunization Programm of more than 120 developing and middle-income countries.