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

Volume 7 , Issue 1 , 2020

Become EABM
Become Reviewer

Graphical Abstract:


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.

[1]
Pharma and emerging markets: Unlocking the potential of emerging economies - Thoughts from the Centre 2019.[cited: 14 April 2019] Available from: https://blogs.deloitte.co.uk/health/2017/06/pharma-and-emerging-markets-unlocking-the-potential-of-emerging-economies.html
[2]
Emerging markets: A global pharmaceutical landscape 2019.[cited: 14 April 2019] Available from: https://qrius.com/emerging-markets-a-global-pharmaceutical-landscape/
[3]
Pharmaceutical quality chemistry, manufacturing, and controls (CMC). Drug master files (DMFs) 2019.[cited: 14 January 2019] Available from: https://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/drugmasterfilesdmfs/default.htm
[4]
Guideline for drug master files (DMF) 2019.[cited: 14 January 2019] Available from: https://www.fda.gov/ drugs/developmentapprovalprocess/formssubmissionrequirements/drugmasterfilesdmfs/ucm073164.htm
[5]
Shaw AB. Drug master files under GDUFA: DMF basics 2013. [cited: February 13 2013] Available from: https://www.fda.gov/media/85079/download
[6]
Completeness assessments for type II API DMFs under GDUFA 2019. [cited: 9 February 2019] Available from: https://www.fda.gov/downloads/drugs/ guidances/ucm321884.pdf
[7]
The common technical document for the registration of pharmaceuticals for human use: quality – m4q(r1) quality overall summary of module 2 module 3 : quality 2002. [cited: 11 November 2018] Available from: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf
[8]
Brazilian health regulatory agency – ANVISA. API registration department – COIFA. Assessment pol 2019. [cited: 14 April 2019] Available from: https://www20.anvisa.gov.br/coifaeng/guia/3.2.S.1.1.html
[9]
Active pharmaceutical ingredients: questions, answers and legislation 2016. [cited: 13 April 2019] Available from: https://www20.anvisa.gov.br/coif aeng/pdf/qandaeng.pdf
[10]
CFDA’s current requirements on 3.2.S of DMF (For generic API). Technical guideline for post approval manufacturing process change of chemical drugs 2016. Available from: https://www.fda.gov/media/ 115733/download
[11]
Hyun OH. Korea GMP & DMF. 2015. [cited: 16 April 2019] Available from: http://www.japta.or.jp/site/ wp-content/uploads/CPhIJapan2015_2.pdf


Rights & PermissionsPrintExport Cite as

Article Details

VOLUME: 7
ISSUE: 1
Year: 2020
Page: [71 - 81]
Pages: 11
DOI: 10.2174/2213476X06666190916122404

Article Metrics

PDF: 14
HTML: 2
EPUB: 2
PRC: 1