A Study of procedures for Dossier Preparation and their marketing authorisation in different countries of selected drug(s)

  • Veerendra Kr. Gautam Executive in Drug Regulatory Affairs Department
  • Mohamad Irfan Research Associate; Jubilant Chemsys Ltd
Keywords: Dossier Preparation, ASEAN countries, ACTD, ICH guidelines


Dossier is a collection of documents on the particular subjects. Any preparation of pharmaceutical product for human use go through the process of reviewing and assessing the dossier of pharmaceutical product which contains details information about administrative, quality, non-clinical and clinical data. This process is governed and permitted by Drug Regulatory Authority of a particular country and process is called as NDA in USA, MAA in EU and other countries as simply Registration Dossier. There are basically two formats for dossier preparation i.e. ICH-CTD and ACTD.

Author Biographies

Veerendra Kr. Gautam, Executive in Drug Regulatory Affairs Department

Executive in Drug Regulatory Affairs Department,
East African (India) Overseas, Gurgaon,
Haryana, India

Mohamad Irfan, Research Associate; Jubilant Chemsys Ltd

Research Associate; Jubilant Chemsys Ltd.
Noida , Uttar Pradesh, India


1. Dictionary reference. https://dictionary.reference.com/browse/dossier?s=ts.(accessed August 2014).
2. World Health Organization Homepage www.apps.who.int/prequal/info.../GenericGuideline_PDS_CTD-Format.pdf. (accessed August 2014).
3. World Health Organization Homepage www.apps.who.int/prequal/info_general/documents/ WHO_DMP_RGS_98_5_R.pdf. (accessed August 2014)
4. Pharma Tutor Homepage
https://www.pharmatutor.org/articles/registration-dossier-pharmaceuticals. (accessed August 2014).
5. Central Drug Standard Control Organisation Homepage
www.cdsco.nic.in/writereaddata/CTD%20Guidance%20Final.pdf. (accessed August 2014).
6. International Journal of Pharmaceutical Sciences Review and Research Homepage
https://www.globalresearchonline.net/journalcontents/volume9issue2/Artic.... (accessed August 2014).
7. World Health Organization Homepage; https://www.who.int/en/ (accessed August 2014).
8. Pan American Health Organization (PAHO) Homepage; https://www.paho.org/hq/ (accessed August 2014).
9. World Trade Organization (WTO) Homepage; https://www.wto.org/ (accessed August 2014).
10. ICH Homepage https://www.ich.org/home.html (accessed August 2014).
11. Spark Pharma Regulatory Consultant Homepage;
https://www.sparkpharmareg.com/pharmaceutical_regulatory_affairs.html (accessed September 2014).
12. Perfect Pharmaceutical Consultant Pvt. Ltd. Homepage
https://www.perfectdossier.com/ctd-dossiers.html (accessed September 2014).
13. Regulatory Affairs Professionals Society (RAPS) Home Page https://www.raps.org/Regulatory-Focus/News/Databases/2015/04/06/21908/Th... (accessed September 2014).
14. ICH Homepage; https://www.ich.org/products/ctd.html (accessed September 2014).
15. ICH Homepage https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R3_ Organization/M4_R3__organization.pdf. (accessed September 2014)
16. ICH Homepage https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_ Quality /M4Q__R1_.pdf. (Accessed September 2014).
17. ICH Homepage
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R2__S.... (accessed September 2014).
18. ICH; https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R1__E....
(accessed September 2014).
19. Association of Southeast Asian Nations (ASEAN); https://www.asean.org/ (accessed September 2014).
20. Health Science Authority (HSA) Singapore Homepage https://www.hsa.gov.sg/content/hsa/en.html (accessed September 2014).
21. Institute of Developing Economies Japan External Trade Organization ;
https://www.ide.go.jp/English/Publish/Download/Report/2008/pdf/2008_0111.... (accessed September 2014).
22. Asean Development Bank Homepage https://www.adb.org/sites/default/files/publication/156295/adbi-wp440.pdf. (accessed October 2014).
23. Ministry of Health Brunei Darussalam Homepage
www.moh.gov.bn/pharmacyservices/download/ASEAN%20Common%20Technical%20Do...(ACTD).pdf(accessed October 2014)
24. Bayer: Science for better life - Canada. www.bayer.ca/files/STIVARGA-PM-ENG-2OCT2013-159750.pdf. (accessed October 2014).
25. U.S. Food and Drug Administration Homepage
https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm321378.htm. (accessed October 2014).
26. Central Drug Standard Control Organisation Homepage https://www.cdsco.nic.in/forms/default.aspx.
(accessed October 2014).
27. Central Drug Standard Control Organisation Homepage
https://www.cdsco.nic.in/forms/list.aspx?lid=1820&Id=11. (accessed October 2014).
28. U.S. Food and Drug Administration Homepage
https://www.fda.gov/safety/medwatch/safetyinformation/ucm355781.htm. (accessed 0ctober 2014).
29. U.S. Food and Drug Administration Homepage
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203085lbl.pdf. (accessed 0ctober 2014).
30. Drug bank Homepage https://www.drugbank.ca/drugs/DB08896. (accessed November 2014).
31. Drug bank Homepage https://www.drugbank.ca/drugs/DB06203. (accessed November 2014).
32. Drug bank Homepage https://www.drugbank.ca/drugs/DB01656. (accessed November 2014).
33. Medicine Control Authority of Zimbabwe. https://www.mcaz.co.zw/. (accessed November 2014)
34. Center for Pharmaceutical Administration Health Sciences Authority – Singapore
https://www.hsa.gov.sg/content/hsa/en.html. (accessed November 2014)
35. Therapeutic Goods Administration - Australia. https://www.tga.gov.au/. (accessed November 2014).
How to Cite
Gautam, V. and Irfan, M. 2017. A Study of procedures for Dossier Preparation and their marketing authorisation in different countries of selected drug(s). PharmaTutor. 5, 10 (Oct. 2017), 8-22.