A comparative study on regulatory requirement of parenteral dosage form for various regulated countries

  • Vishva Acharya
  • Ankit Trivedi
  • Vinit Movaliya
  • Khushboo Vaghela
  • Niranjan Kanaki
  • Maitreyi Zaveri


Parenteral products are at present extensively used for the emergency situation, as it gives maximum bioavailability. Parenteral product legislation is vital because if not sterile, nonpyrogenic can cause severe damage to health causing life-threatening danger to patient. From the above findings it is concluded that the US, being the world's biggest pharma market, also accounts for the largest chunk of the overall injectable space. For the registration of Parenteral product, TGA adopted some (not all) EU guidelines. On the other hand, health Canada mostly follows USFDA regulation guidelines for the submission of the drug product. As discussed above comparative study of regulation and registration process for Parenteral dosage form will be useful regulatory point of view as well as business development point. With this overview the Industry can harmonize dossier application in better way, which will help in reducing time for products to go in market.

Keywords: Parenteral products, USFDA, TGA, EU, New Molecular Entity (NME), ANDA, NDA, CTD


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How to Cite
Acharya, V., A. Trivedi, V. Movaliya, K. Vaghela, N. Kanaki, and M. Zaveri. “A Comparative Study on Regulatory Requirement of Parenteral Dosage Form for Various Regulated Countries”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 2, June 2023, pp. 37-49, doi:10.22270/ijdra.v11i2.589.

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