FACULTY OF PHARMACY
M. Pharmacy (Pharmaceutics) I-Semester (Main Backlog) Examination,
February 2019
Subject Regulatory Affairs
Time: 3 Hours Max. Marks: 75
Note: Answer any Five Questions. All Questions Carry Equal Marks.
1. Describe various parts of master formula record and write its importance. 7
Explain salient features of Hatch Waxman Act and its amendments. 8
2. Enlist different sections of NDA and Write a note on NDA approval process. 15
3. Explain regulatory requirements of US registration for foreign durgs. 8
Explain SUPAC guidelines specific to manufacturing changes 7
4. Describe the objectives of harmonization guidelines. Enlist ICH quality guidelines. 10
Explain the objectives of CMC considerations during drug development. 5
5. Explain the regulatory requirement for biologics product approval. 8
What is the purpose of Investigator's Brochure? Give a brief note on the
Information to be filled in each part of the IB. 7
6. Write a note on eCTD. 7
Write different designs of BE studies for Generic drugs assessment. 8
7. Give an outline of factors that must be addressed in the clinical trial protocols as
per USFDA check list. 8
Give a brief note on Pharmacovigilance and safety monitoring in clinical trials. 7
8. Write brief notes on:
a. Regulatory requirements of EU 7
b. Health Insurance Portability and Accountability Act. 8