Regulatory requirements for preparation of Dossier for registration of Pharmaceutical products in ACTD & CTD format

  • Shrikant Godiyal

Abstract

To prepare and compile the Dossier required for Registration of Pharmaceutical Products as per the requirements of each countries which shall be acceptable internationally to develop one regulatory approach. To avoid variation in the documents submitted in the form of dossier for registration of Pharmaceutical Products in the different countries of the world it’s important to know the requirements of Regulatory Authorities of each countries in which the Dossier is filled for the smooth Registration. This agreed upon common format in the form of CTD format and ACTD format for the technical documentation will significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and will be more ease to submit the file having electronic database.

Keywords: Dossier, Registration, ACTD, CTD, ASEAN, Regulatory Authority

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References

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How to Cite
Godiyal, S. “Regulatory Requirements for Preparation of Dossier for Registration of Pharmaceutical Products in ACTD & CTD Format”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 2, June 2019, pp. 51-61, doi:https://doi.org/10.22270/ijdra.v7i2.318.