B.Pharm Pharmaceutical Regulatory Science Notes

PHARMACEUTICAL REGULATORY SCIENCE UNIT-WISE NOTES – BP804ET

Unit – 1

• New Drug Discovery and development: Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical activities, clinical studies, Innovator and generics, Concept of generics, Generic drug product development.

Unit – 2

• 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)

Unit – 3

• Registration of Indian drug product in overseas market: Procedure for export of pharmaceutical products, Technical documentation, Drug Master Files (DMF), Common Technical Document (CTD), electronic Common Technical Document (eCTD), ASEAN Common Technical Document (ACTD)research.

Unit – 4

• Clinical trials: Developing clinical trial protocols, Institutional Review Board / Independent Ethics
• committee – formation and working procedures, Informed consent process and procedures, GCP obligations of Investigators, sponsors & Monitors, Managing and Monitoring clinical trials, Pharmacovigilance – safety monitoring in clinical trials

Unit – 5

• Regulatory Concepts: Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book,
• Federal Register, Code of Federal Regulatory, Purple book