International Journal Of Drug Regulatory Affairs
  • Year: 2023
  • Volume: 11
  • Issue: 2

Regulatory requirements for the new drug approval process in different countries

Assistant Professor, Acharya and BM Reddy College of Pharmacy, Bangalore, Karnataka, India - 560107

Online published on 15 July, 2023.

Abstract

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)