Master of Pharmacy (M.Pharm.) in Drug Regulatory Affairs Syllabus 2025: Subjects, Specializations, and Semester-wise Syllabus

Syllabus for Master of Pharmacy (M.Pharm.) in Drug Regulatory Affairs course

The Master of Pharmacy (M.Pharm.) in Drug Regulatory Affairs is a specialized program designed to equip students with a comprehensive understanding of the complex and dynamic field of drug regulation. The course syllabus typically covers a wide range of subjects including pharmaceutical laws and regulations, drug approval processes, quality control, pharmacovigilance, and global harmonization efforts. Students delve into the intricacies of pharmaceutical documentation, regulatory submissions, and compliance with international standards. They also study the ethical and legal aspects of drug development, marketing, and post-marketing surveillance. The program often includes practical training in regulatory affairs, providing hands-on experience in preparing regulatory dossiers and interacting with regulatory authorities. By the end of the program, graduates are well-prepared to pursue careers in pharmaceutical companies, regulatory agencies, or consulting firms, where they play a vital role in ensuring the safety, efficacy, and quality of pharmaceutical products, and navigating the ever-evolving landscape of drug regulations.

1st Year OR 1st & 2nd Semester Syllabus of Master of Pharmacy (M.Pharm.) Drug Regulatory Affairs

S.no	Subjects
1	Good Regulatory Practices
2	Documentation and Regulatory Writing
3	Clinical Research Regulations
4	Regulatory Aspects of Drugs & Cosmetics
5	Regulatory Aspects of Herbal & Biologicals
6	Regulatory Aspects of Medical Devices
7	Regulatory Aspects of Food & Nutraceuticals
8	Seminar

2nd Year OR 3rd & 4th Semester Syllabus of Master of Pharmacy (M.Pharm.) Drug Regulatory Affairs

S.No	Subjects
1	Research Methodology and Biostatistics
2	Discussion / Presentation
3	Research Work