Abstract

DRUG MASTER FILES PREPARATION AND REQUIREMENTS FOR MARKETING AUTHORIZATION OF API IN EUROPEAN COUNTRIES

Ch. Bala Madhu Kiran*, M. V. Nagabhushanam, D. Prakash Reddy, G. Yaswanth Sai, G. Ramakrishna, Y. Ratna Sindhu and Brahmaiah Bonthagarala

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Abstract

Marketing authorization application (MAA) for preparation of Drug Master Files (DMF‟s) in the European countries for active pharmaceutical ingredient [API]. This guideline primarily addresses the organization of the information to be presented in registration applications for new pharmaceuticals (including biotechnology-derived products). This guideline is not intended to indicate what studies are required. It merely indicates an appropriate format for the data that have been acquired. Applicants should not modify the overall organization of the Common Technical Document in the guideline. However, in the Nonclinical and Clinical Summaries, applicants can modify individual formats if needed to provide the best possible presentation of the technical information, in order to facilitate the understanding and evaluation of the results. The European Drug Master File (DMF) procedure may be used when the Active Substance Manufacturer (ASM) is not the applicant for a product marketing authorization (applicant), with a view to protect valuable know-how on the manufacturer of the active substance. A DMF is a document containing the information required to demonstrate that the quality of the active subAstance is adequately controlled by the specification proposed by the applicant relevant information required is supplied.

Keywords: Drug Master Files (DMF?s), Marketing authorization application (MAA), active pharmaceutical ingredient [API], European Drug Master File (DMF), Active Substance Manufacturer (ASM)