Good Practices in Management of deficiencies in CTD dossier and comparative study for US, EU and Australia

  • Pooja Chaudhari ROFEL Shri G.M Bilakhia College of Pharmacy
  • Jitendra Kumar Badjatya

Abstract

This topic aims at reviewing the drug and drug product filing and obtaining USFDA EMEA and TGA approval and its effective role to improve the standards which are laid by them. The respective Regulatory Agency approves the new/generic drug products that govern respective market before introduction of particular product into the market. The Regulatory Agency approves the entire new drug product to be safe and effective before marketing. USFDA is the Regulatory Agency which is responsible for the regulation of food and drug product in USA. EMEA is the Regulatory Agency which is responsible for the regulation of food and drug product in Europe. TGA is the Regulatory Agency which is responsible for the regulation of therapeutic goods in Australia.


A dossier contains detail information about the drug substance and drug product and result of studies that are carried out in development process. For getting market authorization has to be submitted to the respective regulation bodies. Due to various regulations, ICH introduced CTD for such countries that come under it. CTD is critical for dossier submission. For regulatory submission that is to be accepted in all ICH countries.


CTD provides standardized structure. CTD makes filing easier globally. But there are differences in dossier submission requirements in these countries i.e. Module I is country specific and other regional guideline are also considered while compiling dossier application.

Keywords: Dossier Registration, CTD, Chemistry Manufacturing Control (CMC), USFDA, EMEA, TGA.

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References

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How to Cite
Pooja Chaudhari, and J. K. Badjatya. “Good Practices in Management of Deficiencies in CTD Dossier and Comparative Study for US, EU and Australia”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 4, Dec. 2019, pp. 40-55, doi:10.22270/ijdra.v7i4.371.

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