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

Author(s): Kunta N. Reddy, Surenahalli G. Vasantharaju*

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Continued as Applied Drug Research, Clinical Trials and Regulatory Affairs

Volume 7 , Issue 1 , 2020

Graphical Abstract:


Background: A DMF consists of confidential information, usually related to Chemistry, Manufacturing and Control (CMC) of the drug substance. DMF is prepared and submitted by the pharmaceutical manufacturer solely to the regulatory authority of the respected country where he wants to market.

Objective: Compare the regulations of the emerging markets with that of a regulated market and to highlight the stringent requirements imposed by emerging authorities. The similarities and differences of the requirements for filing a DMF in emerging markets are compared against the regulated market.

Methods: The method carried out for every single study follows some patterns and certain pathways in order to reach its target. Method begins with scope and objective of regulatory perspective of DMF filing requirements for USA, China, Brazil and Korea. The information was collected from Regulatory authorities, Legislations, Guidelines and Experts opinion.

Results: Regulatory requirements for filing a DMF for API registration vary from country to country. Even though a standard ICH-CTD format is available and most widely followed, there are some specific requirements recommended by drug authorities which are mandatory to be provided while filing to that particular country.

Conclusion: Based on the current study it is clear that emerging markets possess more stringent requirements for API approval as compared to the regulatory market but the dispute is that the emerging markets do not have harmonized guidelines and are not transparent enough.

Keywords: Emerging markets, drug master file, API registration, regulatory requirements, quality data, drug substance.

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Article Details

Year: 2020
Published on: 03 March, 2020
Page: [71 - 81]
Pages: 11
DOI: 10.2174/2213476X06666190916122404

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