Society

WHO: China complying with vaccine regulation standards

(Xinhua)
Updated: 2011-03-01 18:57

BEIJING - The latest World Health Organization (WHO) assessment shows China is complying with international standards for vaccine regulation, a WHO official announced here Tuesday.

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," Lahouari Belgharbi, a scientist of the WHO Department of Immunization, Vaccines and Biologicals, told a conference in Beijing.

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"Chinese manufacturers can (now) submit applications to have their vaccine pre-qualified by WHO," he said.

Belgharbi headed a WHO group to conduct the latest assessment in December last year, 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.

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

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.

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

This could eventually open the door for vaccines produced in China to be supplied through United Nations agencies to developing countries, according to the statement on the WHO website.

It is expected that vaccines from China could be prequalified 1-2 years from now, said the WHO statement.

Currently, China has 36 vaccine producing plants to produce 49 kinds of vaccines against 27 diseases, with annual capacity of nearly 1 billion doses, according to SFDA statistics.

China failed to pass the WHO vaccine regulatory system assessment in 1999, 2001 and 2005.

"Getting WHO approvement this time proves our improved vaccine regulation efforts and guaranteed vaccine quality," said Shao Mingli, head of the SFDA.

A new Good Manufacturing Practice (GMP) code adopted by the SFDA took effect Tuesday. In line with international standards, the new code puts in place stricter requirements for vaccine production to ensure production of vaccines of assured quality.