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

  • Posted on: 30 September 2017
  • By: admin

 

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October 2017 ARTICLE LIST >>

PharmaTutor (October - 2017)

 

ISSN: 2347 - 7881
(Volume 5, Issue 10)

 

Received On: 07/06/2017; Accepted On: 08/06/2017; Published On: 01/10/2017

 

AUTHORS:
Veerendra Kr. Gautam*1, Mohamad Irfan2
1Executive in Drug Regulatory Affairs Department,
East African (India) Overseas, Gurgaon, Haryana
2Research Associate; Jubilant Chemsys Ltd.
Noida , Uttar Pradesh, India
*dra.veerendra.gautam@gmail.com

 

 

ABSTRACT:
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.

 

 

How to cite this article: Gautam VK, Mohamad I; A Study of procedures for Dossier Preparation and their marketing authorisation in different countries of selected drug(s); PharmaTutor; 2017; 5(10); 8-22

 

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