Imperfect Pharmacy Notes 8th Semester
PHARMACEUTICAL REGULATORY SCIENCE
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.
OPEN UNIT 1
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).
OPEN UNIT 2
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.
OPEN UNIT 3
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.
OPEN UNIT 4
Unit 5
Regulatory Concepts
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal
Register, Code of Federal Regulatory, Purple book.