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U.S. Department of Health and Human Services

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Helping China to gradually adopt VICH standards and guidance

In September 2011 CVM experts met with Dr. Zhongqiu Zhang, Director General of the Bureau of Veterinary Medicine, MOA to discuss China’s participation in the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). VICH is an industry/government international collaborative effort in which the EU, US, Japan, Canada, Australia, and New Zealand have developed consensus guidance on the standards and test protocols for studies required to demonstrate safety, efficacy, and quality of veterinary medicines. Promoted by OIE, VICH has made significant recent efforts to outreach to more countries and regions that are developing animal medicines, encouraging them to become knowledgeable of, and participate in, VICH’s standard-setting activities. CVM experts, including Dr. Merton Smith, FDA’s representative to the VICH Steering Committee, explained and recommended that VICH standards and guidance could be used by China to help build its capacity to ensure food safety for those drugs used in food-producing animals and to help to have Chinese studies accepted by other countries. As a result of these CVM efforts, Dr. Zhang and Dr. Sun Yang, Director of International Cooperation and Affairs, Bureau of Veterinary Medicine, MOA, agreed to participate in future meetings of VICH’s Outreach Forum. Since 2011, China has sent experts to attend the last three VICH meetings in Tokyo, Brussels, and Washington. China’s participation in VICH is helping to assure that China conducts preapproval studies using VICH testing protocols. It is also likely that China’s participation in VICH has encouraged similar recent participation by representatives from India, Russia, Brazil, as well as others.