Medicinal raw materials of the proposed implementation of record management
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Medicinal raw materials of the proposed implementation of file management. September 20, the State Food and Drug Administration announced on its official Web site of "medicinal raw materials and record management requirements (draft)", started for public comment. At present, the majority of medicinal raw materials to take up for examination and approval management system. Among them, bulk drugs, drug packaging to take up for approval and payment of all approval numbers of some herbal extracts and materials to take up for approval and issuance of approval. Implementation of record management system, "Those who have approved the listing of drugs of bulk drugs, herbal extracts, medicinal materials, direct contact with drug packaging materials and containers for raw and auxiliary materials to be filed." Draft regulations, the manufacturer of pharmaceutical raw materials should be established in the drug regulatory department of medicinal raw materials and record the information platform, in accordance with the raw materials required by the relevant information. Drug manufacturers are using raw materials and auxiliary materials shall be filed with the original message is always consistent, and if not, should take the initiative to stop using. State Food and Drug Administration to concerned parties, the implementation of pharmaceutical raw materials and filing system, the main purpose is to further clarify the pharmaceutical manufacturers and producers of raw materials, the relationship and respective responsibilities. Clear the system, product quality is the preparation of the first companies responsible should be in the choice of raw and supplementary materials suppliers and other practical aspects of the audit responsibility. Meanwhile, the filing system also emphasized the production of medicinal raw materials, raw and auxiliary materials enterprises authenticity of the information responsible for the record.