Regulatory approval and authority handwritten notes

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UNIT 2 Regulatory approval and authority handwritten notes …… bpharmacy 8sem BP804 ET …


Unit II 


Regulatory Approval Process

Approval processes and timelines involved in Investigational New Drug (IND), New

Drug Application (NDA), Abbreviated New Drug Application (ANDA). Changes to an

approved NDA / ANDA.

Regulatory authorities and agencies

Overview of regulatory authorities of India, United States, European Union, Australia,

Japan, Canada (Organization structure and types of applications)








The research, development, and approval of a drug product are continuous but lengthy . To learn and understand the basics of drug approval.stiogk ohcog


To summarize the changes to an approved NDA/ANDA approval process. To outline and navigate the drug review and approval process.


To understand the concepts of an IND/NDA/ANDA.asalot .kasoe ob


(2.1) for new product approvall3 To explain the timelines involved in various applications submitted for approvals