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Tuesday, October 19, 2010

Chinese State Food and Drug Administration Proposed Route of Registration for APIs, Excipients and Auxiliary Materials

State Food and Drug Administration (SFDA) of China recently published a draft document describing their proposed route of registration of API, excipients and auxiliary material manufacture and quality assurance. The registration route is based on their analysis of the Drug Master File (DMF) content and process used in the US and EU. Of particular interest:

· The drug product manufacturer is the entity responsible for the quality of component materials used in the drug

· Scope covers drugs registered for sale in China, apparently not APIs or excipients which are made for export only

· Clinical investigational materials are not addressed in this document

· Audit reports from the drug product manufacturer audit of their suppliers mentioned in this document must be submitted in the filing

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