Go homepage(回首页)
Upload pictures (上传图片)
Write articles (发文字帖)

The author:(作者)qq
published in(发表于) 2014/7/5 8:36:33
China National regulatory system through the who assessment

Southern correspondent ICBC Beijing

The World Health Organization (WHO) Director-General Margaret Chan announced in Beijing today: managing the who experts ' assessment, China National regulatory systems meet or exceed all standards who operate according to international standards. This means that China's vaccine production processes, safety and effectiveness are in line with international standards.

"Chinese parents to domestically produced vaccines can have more confidence," WTO representative office of EPI project leader Dr Lance said.

This morning, the State food and drug supervision administration and who also signed the letter of intent. Parties will cooperate in an existing vaccine regulatory system on the basis of bilateral cooperation will be extended to other areas of food and drug administration.

WTO representative office of EPI project leader Dr Lance said, hoping China's food and drug regulatory standards and international practice. "After the international harmonization of standards and the safety of Chinese food and drug products and global. ”

In April, the who to reassess the vaccine regulatory system in China. WTO assessment expert team said Belgharbi, China once again pass the assessment in that China has mature vaccine regulatory system, meaning that vaccines national vaccine standards and international standards will be uniform.

Who assessments of national regulatory system for vaccines, is a worldwide recognized, comprehensive scientific assessments of national vaccine regulatory level of international examination. The scope of the assessment involves 7 plates, composed of regulatory systems, permits and licensing, postmarketing regulation including the monitoring and surveillance of adverse events after vaccination to check, clinical trials, regulatory, lot release, laboratory management, 7 plates.

At present, China can produce 61 33 disease prevention vaccine, the annual production capacity of nearly 1 billion doses. It is understood that the vaccine regulatory system of one country only, who recognized the country's production of vaccine can be a declaration of who's prequalification of essential qualifications, certified by international bodies like the United Nations Children's Fund in vaccine procurement list. Last October, first through the who prequalification of vaccines in China--Chengdu Institute of biological products vaccine, was included in the list of United Nations procurement.

(Original title: after 3 years, again by the who to assess the Chinese vaccine regulatory system)

赞