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IPQ Inside the global regulatory dialogue

China Projected to Become Major Global Vaccine Supplier with WHO Imprimatur and Overhauled Regulatory Infrastructure

Jul 3rd, 2012

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The World Health Organization (WHO) certification of China’s FDA (SFDA) as a “competent authority,” and the quality regulatory upgrades the WHO imprimatur reflects, have opened the door for China to become a major player in the global marketplace for vaccines, WHO Director-General Margaret Chan said at the 65th World Health Assembly held in late May in Geneva, Switzerland.

“Once individual vaccines are prequalified by WHO,” she explained, “the country’s capacity to produce a large number of vaccines at very low prices will revolutionize vaccine supplies and their prices.”

Major rewrites of China’s GMPs and its pharmacopeia, and other efforts by the government to encourage and require modernization in pharmaceutical manufacturing and testing, contributed to China’s ability to be recognized by the world body as a competent authority.

In January 2011, SFDA and China’s Ministry of Health (MoH) approved a significant revision to its GMPs that became effective in March, 2011.  Commenters on the revision included FDA and WHO – the latter providing particularly positive comments on the effort.

At the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting in Washington, DC, in late October, Shanghai FDA (ShFDA) Chief Inspector and GMP Department Head Hua Zhang, who was a primary author of the GMP revision, explained that new requirements for quality risk management and quality systems were added, as well as internationally harmonized expectations for the manufacture of sterile products (IPQ “The News in Depth” November 10, 2011).

In August 2011, an official English translation of the 2010 revision of the Chinese Pharmacopeia was published (IPQ “The News in Depth” November 13, 2011).  It is available in hard copy and is comprised of three bound editions that together contain over 3,000 pages covering over 4,500 monographs.  Almost 1,400 of these are new since the last edition was published in 2005, and another 2,200 have been revised.

SFDA has also harmonized its CMC review process with Western models and taken steps to bring its application format more into line with the ICH common technical document (IPQ “The News in Depth” November 13, 2011).

At the AAPS National Biotech Conference in San Diego in late May, China National Institute for the Control of Pharmaceutical and Biological Products official Tang Jian Rong provided details concerning: ● the areas assessed by WHO in its approval of SFDA ● how that approval clears the way for Chinese vaccine production and sale on the world market ● modernization of analytical methods in China, and ● how the revised Chinese Pharmacopeia raises the bar for domestic pharma companies.

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