Comparison of Regulatory Requirements for Filing Drug Master File (DMF) in Emerging Markets – China, Brazil & South Korea

(E-pub Ahead of Print)

Author(s): Neha Reddy K, Vasantharaju S G*.

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs

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Drug Master File (DMF) is a document which provides confidential information regarding the details of manufacturing facilities, process, packaging and storage of drug substance or active pharmaceutical ingredient used to manufacture human drug products. API registration requirements for filing a DMF vary from country to country. Although ICH-CTD format is widely followed, there are country specific information which are mandatory to be provided while filing to a particular country. The critical aspect of this study is to summarize the specific requirements to be documented when filing a DMF in emerging markets (China, Brazil and South Korea) and to compare them with that of a regulated market and highlight the stringent requirements posed by emerging authorities.

Keywords: Emerging markets; Drug master file; API registration; Regulatory requirements; Quality data; Drug substance

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(E-pub Ahead of Print)
DOI: 10.2174/2213476X06666190916122404

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