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RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
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Posted 03 January 2014 | By Louise Zornoza,
According to a bulletin issued by the China Food and Drug Administration (CFDA) on 31 December 2013, manufacturers of blood products, vaccines and injectable drugs that have not obtained certification of compliance with the revised (2010) good manufacturing practices (GMP) may not market those products as of 1 January 1 2014.
Companies with facilities that have passed GMP inspection prior to January 1, 2014, may continue to manufacture products, but those products may not be marketed until after the actual certificate of GMP compliance has been issued. All other manufacturers must first apply for and obtain GMP certification before engaging in the production of these products.
CFDA Bulletin
Read all Breaking News from RegLink
Tags: Vaccine, GMP
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