Title:Comparison of Regulatory Requirements for Filing Drug Master File (DMF) in Emerging Markets - China, Brazil & South Korea
Volume: 7
Issue: 1
Author(s): Kunta N. Reddy and Surenahalli G. Vasantharaju*
Affiliation:
- Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, MAHE, Karnataka,India
Keywords:
Emerging markets, drug master file, API registration, regulatory requirements, quality data,
drug substance.
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.
