Drug Master Files sindusfarma药物主文件sindusfarma.br.pptVIP

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2017-02-13 发布于上海
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Drug Master Files sindusfarma药物主文件sindusfarma.br.ppt

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EU DMF (EDMF or ASMF) Established in 1989-1991 Revised in 2005 and became ASMF (Active Substance Master File) after implementation of CTD in EU Applicable only to active substances Has been divided into 2 parts Applicant Part (Open) ASM Restricted Part (Closed / Confidential) European Master File The DMF contains information which includes valuable know-how which should be kept confidential and submitted to the authorities only. Therefore, it should be divided into 2 parts – an applicant’s part and an ASM Restricted Part. The applicant’s part of a DMF is provided by the ASM (Active Substance Manufacturer) to the applicant directly and becomes part of the application for marketing authorization. Both the applicant’s part and the ASM Restricted Part of the DMF are submitted to the authorities. Applicant’s part of a DMF – opening part The applicant must be supplied by the ASM with sufficient information to be able to take responsibility for an evaluation of the suitability of the active substance specification to control the quality of the substance. This normally includes a brief outline of the manufacturing method, information on potential impurities originating from the manufacturing method, from the isolation procedure (natural products) or from degradation and, where applicable, information on the toxicity of specific impurities. ASM Restricted Part of DMF – closing part Detailed information on the individual steps of the manufacturing method such as reaction conditions, temperature, validation and evaluation data for certain critical steps of the manufacturing method, etc. and on quality control during manufacture may contain valuable know-how. Such information may therefore be supplied to the authorities only. * EU: Documenting Quality: 4 Options In Europe there are four ways to document the quality of the drug substance for the purpose of marketing authorization: Certificate of Suitability of the pharmacopoeia monograph (CEP) Full details of manufacture (