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Enforcing GMP on Chinese Medicine Yin Pian Industry in China
State Food and Drug Administration (SFDA) had on 5 February 2008 issued an announcement of “Enhancing the Control on Chinese Medicine Yin Pian Manufacturing” (The Announcement). The Announcement intends to impose a tighter control in the production, distribution and consumption of Chinese medicine Yin Pian (CM). Starting from 1 January 2008, manufacturers without “GMP Certificate” cannot be engaged in the manufacturing of CM. All CM-related business enterprises and end-users of CM (including manufacturer and medical institutions) must purchase CM from accredited manufacturers and distributors. The Announcement also urged drug regulatory departments to closely monitor the implementation of the regulation. Those who fail to comply with the requirements are subject to penalty as stipulated in the Drug Administration Law.
To ensure drug safety of CM products manufactured in mainland China, SFDA had in 2004 issued a notice for introducing GMP into the manufacturing of CM. The notice required that, starting from 1 January 2008, all CM manufacturing must meet the GMP standards. In addition, all purchases of CM by user companies must be made from accredited manufacturers, accompanied by a copy of the GMP certificate. However, products purchased on or before 12 December 2007 would be exempted. Certificate-holding CM manufacturers must conform to the validated operational methodologies and procedures in the drug manufacturing process. Only validated products specified in the certificate can be manufactured.
Source:
State Food and Drug Administration, PRC www.sfda.gov.cn
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