Herbridge, 22 Sept. 2011_The DMF (Drug Master File) draft system is published for comments by SFDA (State Food and Drug Administration) in China. This means that manufacturers of active pharmaceutical ingredients (API) and pharmaceutical excipients will need to submit detail documents to SFDA for registration if the new legislation is in effect. What opportunities and challenges will be brought to herbal extract manufacturers by the new legislation? What effect will be brought in the herbal industry? The 3th China Natural Ingredients Conference, held in Beijing on 27-28th Oct. 2011, will discuss these issues.
The registration approval system has been used for supervision over all API, medicinal packaging, some herbal extracts and pharmaceutical excipients in China. But as time goes by, there are more and more defects for the system. SFDA drafted the DMF system to improve its administration. The herbal extract industry, which has not been effectively controlled for the past years, will become controllable in the near future. The enforcement of DMF system will upgrade the herbal extract industry in China.
FDA published new dietary ingredient (NDI) draft guidance at late June, which may affect the herbal extract industry in China.
Copyright: www.herbridge.com
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