[China Daily]Regulation of vaccines passes key test

By Shan Juan (China Daily)

BEIJING - China's State Food and Drug Administration (SFDA) has been complying with international standards for the regulation of vaccines, something that will help open the door to the export of domestically made vaccines, said a press release issued by the World Health Organization's (WHO) Beijing Office on Tuesday.

China's national regulatory authorities were recognized as being "functional", said Lahouari Belgharbi, a scientist from the WHO's Department of Immunization, Vaccines and Biologicals.

"Chinese manufacturers can now submit applications to have their vaccine pre-qualified by the WHO," he told Xinhua News Agency.

Belgharbi headed a WHO group that conducted the latest assessment in December. It followed unsuccessful attempts by China to pass the WHO vaccine regulatory system assessment in 1999, 2001 and 2005.

Belgharbi specifically looked at the SFDA's overall regulatory framework, marketing authorization and licensing, post-marketing surveillance and any adverse reactions to vaccines.

The WHO experts visited institutes involved in vaccine regulation in Beijing, Shanghai, Hebei and Jiangsu.

China became the 36th vaccine-producing country to have its regulatory system approved by the WHO, he said.

"It is a validation of the capability of the Chinese regulatory authority," said WHO China Representative Michael O'Leary.

"China produces a large number of vaccines at affordable prices and could make a significant contribution to meeting the world's vaccine needs."

It is expected that specific vaccines from China could be approved in one to two years, said the WHO release.

China has 36 vaccine-producing plants manufacturing 49 kinds of vaccine for 27 different diseases. It has an annual capacity of producing nearly 1 billion doses, according to SFDA statistics.

"Getting WHO approval shows our improved vaccine regulation efforts and guarantees vaccine quality," said Shao Mingli, head of the SFDA.

Liu Peicheng, the media relations director at Sinovac Biotech Ltd, a Beijing-based biopharmaceutical company, also welcomed the news.

"The approval will help boost people's confidence in domestic vaccines which are, as the WHO recognizes, up to international standards," Liu said.

He said it will help Chinese vaccine producers tap into the international market.

China Daily

(China Daily 03/02/2011 page3)

http://www.chinadaily.com.cn/cndy/2011-03/02/content_12098617.htm