“Pharmaceutical Regulatory Science” is a comprehensive and student-friendly book that provides a clear understanding of regulatory principles governing the development, approval, and marketing of pharmaceutical products. The book presents the subject in a simple and systematic manner, enabling readers to grasp both theoretical concepts and practical applications in regulatory affairs.
The text covers the complete process of drug discovery and development, including preclinical and clinical studies, along with detailed insights into regulatory approval pathways such as Investigational New Drug (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA). It also explains the differences between innovator and generic products, highlighting their regulatory requirements and approval processes.
In addition, the book discusses regulatory frameworks and authorities across various countries, providing a global perspective on pharmaceutical regulations. It includes important topics such as drug master files, Common Technical Document (CTD) and eCTD formats, and procedures for registration and export of pharmaceutical products.
The book further explores clinical trials, Good Clinical Practices (GCP), pharmacovigilance, and quality management systems, emphasizing the importance of safety, efficacy, and compliance throughout the product lifecycle. Key regulatory concepts, documentation practices, and guidelines are also presented to strengthen understanding of real-world regulatory operations.
With its structured approach and focus on practical relevance, this book serves as a valuable resource for developing knowledge and skills in pharmaceutical regulatory science, supporting learners in understanding global regulatory requirements and professional responsibilities in the pharmaceutical industry.
1. New Drug Discovery & Development
1. 1 Introduction
1.2 Definitions
1.3 Stages of Drug Discovery
1.4 Preclinical studies
1.4.1 Types of trials
1.5 Non clinical studies
1.5.1 Objectives
1.5.2 Non-clinical regulatory guidelines
1.6 Clinical Research
1.6.1 Designing clinical trials
1.6.2 Investigational new drug process
1.6.3 FDA-IND review team
1.6.4 Approval
1.7 Innovators
1.8 Generic drugs
1.8.1 Selection of a generic drug product for manufacture
1.8.2 Consideration in the selection of a generic drug product
for manufacture
1.8.3 Generic drug approval process
1.8.4 Hatch Waxman act amendement
1.9 Comparison of Generics VS Innovators
2. Regulatory Approval Process
2.1 Introduction
2.2 Investigational New Drug (IND)
2.2.1 Types of IND
2.2.1.1 Investigator IND
2.2.1.2 Treatment IND
2.2.1.3 Emergency use IND
2.2.2 Categories of IND
2.2.2.1 Commercial IND
2.2.2.2 Research (Non- commercial IND)
2.2.3 Information areas of IND
2.2.3.1 Animal pharmacology and toxicology studies
2.2.3.2 Manufacturing information
2.2.3.3 Clinical protocol and investigator information
2.2.4 Resources for IND Application
2.2.4.1 Pre-IND consultation programme
2.2.4.2 Guidance documents for INDs
2.2.4.3 Laws, Regulations, Policies and Procedures
2.2.4.4 Code of Federal Regulations (CFR)
2.2.4.5 Emergency use of an Investigation Drugs
2.2.5 Format and Content of IND
2.3 New Drug Applications (NDA)
2.3.1 Goals of NDA
2.3.2 Guidance Documents for NDA
2.3.2.1 Guidelines for submitting supporting documents
in drug applications
2.3.2.2 Laws, Regulations, Policies and Procedures
2.3.2.3 Codes of Federal Regulations (CFR)
2.3.2.4 NDA forms and electronic submission
2.3.2.5 Advisory Committee
2.4 Abbreviated New Drug Application (ANDA)
2.4.1 ANDA Regulatory review Process
2.4.1.1 Bioequivalence review process
2.4.1.2 Labelling review process
2.5 Regulatory authorities and agencies
2.5.1 Regulatory authority of India
2.5.2 Regulatory authority of USA
2.5.3 Regulatory authority of Europe
2.5.4 Regulatory authority of Australia
2.5.5 Regulatory authority of Japan
2.5.6 Regulatory authority of Canada
3. Registration of Indian Drug Products in Market
3.1 Introduction
3.2 Procedure For Export of Pharmaceutical Products and medicines from India
3.2.1 Getting import export code
3.2.2 Documents to be uploaded
3.2.3 Custom clearance
3.3 Drug Master File
3.3.1 Types of Drug Master File
3.3.2 Submission of Drug Master File
3.3.3 Administrative Information
3.4 Common Technical Document & eCTD
3.4.1 Modules of CTD
3.4.2 eCTD
4. Clinical Trials
4.1 Introduction
4.1.1 Phases of clinical trials
4.2 Protocol
4.2.1 Aims of the protocol
4.2.2 Benefits of the protocol
4.2.3 Protocol Review
4.2.4 Writing the protocol
4.3 Institute Review Board/Independent Ethics Committee (IRB/IEC)
4.3.1 IRB Responsibilities
4.3.2 Composition, Functions and Operations of IRB
4.3.3 Procedure
4.4 Records
4.5 GCP (Good Clinical Practices)
4.5.1 Principles of GLP
4.5.2 Investigator
4.6 Medical Care of Trial Subjects
4.6.1 Compliance with Protocol
4.6.2 Investigational Products
4.6.3 Randomization Procedures and Unbinding
4.7 Informed Consent of Trial Subjects
4.8 Records and reports
4.9 Quality management
4.10 Quality assurance and quality control
4.11 Contract Research Organization (CRO)
4.12 Management, Data Handling, and Record Keeping
4.13 Monitoring Procedure
4.14 Pharmacovigilance
4.14.1 Introduction
4.14.2 Aim
4.14.3 ADRS
5. Regulatory Concepts
5.1 Regulatory Concepts
5.2 Basic Terminology
5.3 Guidelines & Regulations
5.4 Orange Book
5.5 Federal Register
5.6 Code of Federal Regulatory
5.7 The Purple Book
A book as per the latest syllabus given by Pharmacy Council of India (PCI) New Delhi
for B.Pharm students of all Indian Universities
