IMPORTANCE OF DEFICIENCY RESPONSE IN PHARMACEUTICAL ENVIRONMENT FOR DRUG APPROVAL

  • Swagat Tripathy
  • P. N. Murthy
DOI https://doi.org/10.22270/ijdra.v2i4.148

Abstract

This illustrates examples of series deficiencies, that’s how really company faces problem due to deficiency. It’s to convey the message if drug product manufacturer can visualize earlier all aspect of risks and manifest proactively, then there is always least chance to have the said deficiency received. However, even then if company also gets deficiency, company could have equipped with earlier data. So, what they need to do is to focus properly for addressing agency’s query by utilizing proper scientific and technical writing skills. How lack of visualization creates problem, how review cycle prolonged and how by dint of this issue approval got delayed has been clearly discussed in this case study. The reason of so many rounds of questions and review cycles become longer and finally approval got delayed is from the beginning itself agency was not satisfied or convinced with the justification given by said Company.

Keywords: Impurity content, TGA, deficiency, Approval, Review process.

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References

1. What the TGA regulates [Internet]. 2014 [cited 2014 Oct 22]. Available from: https://www.tga.gov.au/tga-basics
2. TGA regulatory framework [Internet]. 2014 [cited 2014 Oct 20]. Available from: https://www.tga.gov.au/who-we-are-what-we-do
3. TGA - The risk-based approach to regulation. Version 1.0 [Internet]. 2012 May[cited 2014 Oct 23]. Available from: https://www.tga.gov.au/tga-regulatory-framework.
4. Effective drug regulation [Internet]. 2014 [cited 2014 Nov 02]. Available from: http://apps.who.int/medicinedocs/pdf/s2300e/s2300e.pdf.
5. TGA - Impurities in drug substances and drug products [Internet]. 2014 [cited 2014 Nov 28]. Available from: https://www.tga.gov.au/book/182-related-impurities-drug-substances-and-drug-products.
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How to Cite
Tripathy, S., and P. N. Murthy. “IMPORTANCE OF DEFICIENCY RESPONSE IN PHARMACEUTICAL ENVIRONMENT FOR DRUG APPROVAL”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 4, Feb. 2018, pp. 14-18, doi:10.22270/ijdra.v2i4.148.
Issue
Vol 2 No 4 (2014): VOLUME 2, ISSUE 4, 2014
Section
Case Study
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