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AKTU Regulatory Affairs (Theory) (BP707T) Syllabus PDF – B.Pharm 7th Semester
Regulatory Affairs (Theory) BP707T
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Official AKTU syllabus of Regulatory Affairs (Theory) (BP707T) for B.Pharm 7th Semester – 2 credits, L-T-P 2-0-0. Read the unit-wise course content, course outcomes, evaluation pattern and recommended books online, or download the PDF.
Syllabus — Regulatory Affairs (Theory)
Download PDFBP707T · 2 credits · L-T-P 2-0-0
Course Objectives
- Understand the drug discovery and development process.
- Identify key regulatory authorities and their roles in drug regulation.
- Describe the regulatory approval processes in India and international markets.
- Understand the documentation and registration procedures for drug products.
- Describe the laws and guidelines governing the pharmaceutical industry.
Course Outcomes
| CO | Upon successful completion of this course, the students will be able to: |
| No. | |
| 1 | Describe the fundamental concepts and organizational structures of regulatory affairs and global regulatory authorities governing pharmaceutical products. |
| 2 | Describe the drug discovery and development process, including preclinical, clinical, and regulatory documentation requirements. |
| 3 | Summarize the regulatory framework, approval procedures, and legal requirements for pharmaceuticals in India. |
| 4 | Compare regulatory approval processes and submission formats across major international markets. |
| 5 | Understand clinical trial requirements, ethics committee roles, informed consent, GCP guidelines, and pharmacovigilance requirements. |
Course Content
| Unit | Topics | No. of |
|---|---|---|
| I | Fundamentals of Regulatory Affairs Introduction to Drug Regulatory Affairs, Overview of regulatory authorities in India and major international markets (US FDA, EMA, PMDA), Role and responsibilities of Regulatory Affairs Professionals, Organizational structure of regulatory bodies. Basic regulatory terminologies: Guidance, Guidelines, Regulations, Laws, Acts. Regulatory reference resources: Orange Book, Purple Book, Federal Register, Code of Federal Regulations (CFR). | 6 hour |
| II | Regulatory Requirements in Drug Development Drug discovery and development process, Drug development teams and their functions. Non-clinical drug development: Pharmacology, Drug metabolism, Toxicology. Regulatory documentation: Investigational New Drug (IND) protocols, Biostatistics in pharmaceutical product development, Bioequivalence (BE) studies, Data presentation for regulatory submissions. | 6 hour |
| III | Indian Regulatory Framework and Approval Process Central Drugs Standard Control Organization (CDSCO) and State Licensing Authorities: Organization and responsibilities, Regulatory requirements for import, manufacture, and sale of pharmaceuticals in India, Certificate of Pharmaceutical Product (COPP), Regulatory approval procedure for new drugs in India, Clinical trial regulatory requirements in India, phytopharmaceutical regulations, Good Clinical Practice (GCP) guidelines and Schedule Y, Innovator and generic drugs, Generic drug product development Phytopharmaceutical regulation by AYUSH and CDSCO. | 6 hour |
| IV | International Regulatory Systems & Global Drug Registration: Types of regulatory applications: Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA) Drug Master Files (DMF), Common Technical Document (CTD), electronic CTD (eCTD), ASEAN CTD (ACTD), Registration procedure for Indian drug products in overseas markets, Post-approval changes to NDA and ANDA. | 6 hour |
| V | Clinical Trials, Ethics, and Post-Marketing Surveillance: Clinical research phases (I-IV), Clinical trial documents, Institutional Review Board (IRB) and Independent Ethics Committee (IEC): Formation and functions Informed consent process and documentation, Good Clinical Practice (GCP) obligations of investigators, sponsors, and monitors, Management and monitoring of clinical trials, Pharmacovigilance: Safety monitoring during clinical trials and post- marketing, | 6 hour |
Recommended References
- Berry, I. R. and Martin, R. P. The Pharmaceutical Regulatory Process. Informa Healthcare.
- Gallin, J. I. and Ognibene, F. P. Principles and Practice of Clinical Research. Academic Press.
- Guarino, R. A. New Drug Approval Process: Accelerating Global Registrations. CRC Press.
- Ng, R. Drugs: From Discovery to Approval. Wiley.
- Pisano, D. J. and Mantus, D. S. Textbook of FDA Regulatory Affairs. Informa Healthcare.
- Weinberg, S. Guidebook for Drug Regulatory Submissions. Wiley.
| Course Code* | Course Title* | Course Type |
| BP708T AEC1 | Current Good Manufacturing Practices (cGMP) | Elective |
| BP708T AEC2 | Pharmaceutical Automation | |
| BP708T AEC3 | Modern Techniques in Cellular Biology | |
| BP708T AEC4 | Medical Devices | |
| BP708T AEC5 | Transformation of Food Waste into Medicinal Products | |
| BP708T AEC6 | Biosimilars, Vaccines & Macromolecules | |
| BP708T AEC7 | Precision Medicine | |
| Credit | Hours Per Week (L-T-P) Hours. | Max. |
| L | T | P |
| 1 | -- | 15 |
| Maximum Marks | SE | ESE |
| 50 | 20 | 30 |
* One course shall be selected from the list The syllabi for elective subjects are given in the APPENDIX
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