World Health Organization (WHO) 3 1 at the Beijing announced that Chinas regulatory system by the WHO vaccine evaluation.

WHO vaccine evaluation system is a measure of a national drug regulation and vaccine quality management an important criterion. The assessment covers the whole process of vaccine regulation, involving all the participating countries, the vaccine regulatory agencies, including the drug regulatory authorities, health authorities, adverse drug reaction monitoring body, disease prevention and control, drug testing agencies. The Chinese vaccine regulatory system assessment by WHO, the vaccine manufacturer pre-certification application for WHO to participate in bidding on the premise of international vaccine, this vaccine for our company early access to the international market basis.

State Food and Drug Administration (SFDA), said Shao Mingli, WHO vaccine regulatory system in China to carry out the assessment of seven major sections, of which 2 out of Top plate, and the remaining five plates also gave a high score, performance has made encouraging, indicating that the quality of vaccines to protect our work is strictly regulated, but also for vaccine manufacturers to enter the international market as soon as possible basis.

According to the WHO assessment team leader 贝尔加比博士 said vaccine manufacturers in China from March 1st to the WHO for pre-certification.

"Landmark"

WHO assessment includes national regulatory system, marketing authorization to work after the listing of supervision (including monitoring of abnormal reactions after vaccination), lot release, laboratory management, clinical trials, regulatory inspection and supervision of seven sections, covering from the vaccine research and development, production, use to monitor adverse reactions after vaccination in all aspects. The seven sections including the 183 project indicators, 88 of which is a key indicator. Only this all through the 88 key indicators, and other non-critical targets by more than half, to pass the assessment. Indicators in the assessment, everything around a core issue - whether the regulatory system specification, can ensure the safe and effective vaccine products.



"Chinas regulatory system for vaccines by WHO assessment score, a milestone." Shao Mingli case highly.

Ministry of Health, SFDA for the assessment of attention. In this process, the Ministry of Health, SFDA effort with, establish and improve the department, bureau coordination mechanisms to strengthen coordination on major issues, strengthening the vaccine post-marketing monitoring, monitoring of adverse reactions and other weak links must be properly resolved within the limited time release new version of GMP and other key issues.

"Through these efforts, between China and the WHO, China and other cooperation between national regulatory system, the road has been open." 贝尔加比博士 said.

Open the door to international procurement

By vaccination, to reduce child mortality and morbidity is one of the UN Millennium Development Goals. To help developing countries, the United Nations and international NGO organizations will support the procurement of vaccines to national immunization planning.

Accordance with international practice, the vaccine vaccine products to enter the United Nations procurement plan, or to obtain approval in other countries and regions, you must first pre-certified by the WHO. This time, our regulatory system through the assessment of the vaccine, indicates that China can apply for the vaccine from the vaccine companies pre-qualified products, participate in international competition, and global disease prevention and control and make due contributions.

From a global point of view, the world produces 30 kinds of diseases, the prevention of various types of vaccine in 2009, the worlds total supply of various vaccines about 8 billion. China is the largest producer of vaccines, vaccine production capacity is strong, relatively complete variety. It is understood that our existing vaccines manufacturer 36 to produce 27 kinds of diseases, the prevention of 49 kinds of vaccine production capacity to nearly one billion, highest in the world. However, the vaccine has not really made out of the country, only some of the small number of companies giving way to a single species or a single way of trade between countries exports, export volume and export range is very limited.

The WHOs vaccine production has been very concerned about our country can look forward to other countries, particularly developing countries to provide products to support disease prevention and vaccination.

"In two years China could become a major supplier of cheap one vaccine, and Chinese exports of vaccines, will no doubt more than 120 developing countries and middle-income countries contribute to immunization programs." Evaluation,贝尔加比博士 said.

WHO representative in China, Rui-ming Lam also said that Chinas large-scale vaccine industry, can produce a variety of affordable vaccine prices through the WHO assessment is the first step.

Although the cooperation of the road has been opened, but to truly win-win cooperation also needs to undergo a process.贝尔加比博士 said, WHO and the SFDA is discussing a new plan in the next two years, WHO will help China continue to improve the regulatory system, and help Chinese enterprises to pre-certification, estimated that Chinas vaccine is expected in the next year or two through pre-certification.

WHO pre-qualified for a particular vaccine is in compliance with international quality standards to ensure safety and effectiveness, is the production company through the United Nations procurement unit will supply the vaccine to other countries a prerequisite. WHO will be pre-certified for each specific product applications for independent evaluation. SFDA has been launched to encourage enterprises to the next step pre-certification.

Wu Zhen, deputy director of SFDA, said vaccine manufacturers in China to promote the WHO pre-certification application and actively participate in international bidding and purchasing vaccines, SFDA has been held in Beijing, a WHO vaccine pre-certification and reporting procedures training courses and seminars held in the vaccine manufacturer will be invited WHO experts to the country where the 36 vaccine companies and provinces (municipalities) Food and Drug Administration is responsible for vaccine production supervision of teaching staff, and discuss the next step to carry out pre-certification roadmap.