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)

21NTRODUGTION REGULATORY APPROVAL PROCESS

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