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A comprehensive study on regulatory requirements for development and filing of generic drugs globally

1,2★, 2, 1, 1, 3★ Corresponding author

  1. 1Drug Regulatory Affairs, Jubilant Life Sciences Ltd., Noida, INDIA.
  2. 2Department of Pharmacy, Lloyd Institute of Management and Technology, Mahamaya Technical University, Greater Noida, INDIA.
  3. 3University Department of Pharmaceutical Sciences, Utkal University, Bhubaneswar, Orissa, INDIA.

CORRESPONDENCE

Shweta Handoo

Drug Regulatory Affairs, Jubilant Life Sciences Ltd., Noida, INDIA.

shweta.hakeem@gmail.com

Volume 2, Issue 3 · pp. 99-105 · 2012 · DOI: 10.4103/2230-973X.104392

ABSTRACT

The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for the companies to develop a single drug which can be simultaneously submitted in all the countries for approval. The regulatory strategy for product development is essentially to be established before commencement of developmental work in order to avoid major surprises after submission of the application. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. It not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution, and promotion of it. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development.

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    Handoo, S., Arora, V., Khera, D., Nandi, P. K., & Sahu, S. K. (2012). A comprehensive study on regulatory requirements for development and filing of generic drugs globally. International Journal of Pharmaceutical Investigation, 2(3), 99-105. https://doi.org/10.4103/2230-973X.104392

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    © 2012 Author(s)

    This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms. CC BY-NC-SA 4.0