Regulatory requirements for the New Drug approval process in different Countries

  • Sangavi C. Assistant Professor


Currently, different nations must adhere to various regulatory standards in order to get a new drug's marketing authorization application (MAA) approved. The US Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the Central Drug Standard Control Organization (CDSCO), the Therapeutic Goods Administration (TGA) in Australia, the State Food and Drug Administration (SFDA) in China, and the Therapeutic Products Directorate (TPD) in Canada were all studied for this production's regulatory requirements and drug approval process.

Keywords: Drug Regulatory affairs, NDA, USFDA, EMA, CDSCO, New Drug Approval Process, FDA, Marketing authorization applications (MAA)


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How to Cite
C., S. “Regulatory Requirements for the New Drug Approval Process in Different Countries”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 2, June 2023, pp. 1-16, doi:10.22270/ijdra.v11i2.574.