GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM – SEMESTER -1 – EXAMINATION –WINTER – 2018
Subject Code: MPH104T Date: 07/01/2019
Subject Name: Regulatory Affair
Time: 10:30 AM TO 01:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make Suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) What do you understand by drug master file? Describe types of DMFs in detail. 06
(b) Describe the investigator’s brochure for IND. 05
(c) Explain in detail CTD Vs eCTD. 05
Q.2 (a) Describe the procedure for new drug approval from CDSCO in India. 06
(b) Give organization structure, activities and responsibilities of TGA. 05
(c) Write a note on International Good Clinical Practices. 05
Q.3 (a) Discuss the salient features of FDA guidelines for clinical trials in India. 06
(b) Discuss in brief about GHTF guidelines for Medical Device. 05
(c) Discuss briefly about ICH safety guidelines S3B. 05
Q.4 (a) What do you understand by trials in special populations? How is documentation 06
done in bioavailability/bioequivalence studies?
(b) Prepare Checklist for HIPAA Compliance. 05
(c) Discuss about clinical research Protocols. 05
Q.5 (a) Enlist ICH Q series guidelines and discuss ICH guideline Q3B(R2) Impurities 06
in new drug products.
(b) Write a note on Pre-market approval process for Biologics in USA. 05
(c) Discuss regulatory requirements for Investigational Medicinal Product Dossier 05
(IMPD)
Q. 6 (a) Describe general consideration, specific requirements and contents of an NDA. 06
(b) Describe about Post marketing surveillance procedure in USA. 05
(c) Describe contents of Investigator brochure used in clinical trial. 05
Q.7 (a) Write a note on Preclinical studies as per CDSCO. 06
(b) Discuss WHO guidelines for the preparation of Master formula record. 05
(c) Describe how Waxman-Hatch Act has simplified and facilitated approval of 05
generic products in US?
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GUJARAT TECHNOLOGICAL UNIVERSITY
M.Ph. – SEMESTER– I • EXAMINATION – SUMMER -2018
Subject Code: MPH104T Date: 09/05/2018
Subject Name: REGULATORY AFFAIRS
Time: 02:30PM TO 05:30PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Write a note on ANDA. Explain the concept of PARA I to IV filling. 06
(b) What is DMF? Write a short note on Type of DMF. 05
(c) Write a note on NDA. 05
Q.2 (a) Give the concept of ANDA & prepare flow chart showing ANDA review 06
process.
(b) Describe various components of FDA. 05
(c) Write a note on Post Marketing Surveillance. 05
Q.3 (a) Explain regulation for medical devices. 06
(b) Define CTD & eCTD. Explain modules of CTD. 05
(c) Explain Regulatory requirements of EU. 05
Q.4 (a) Write a note on MHRA. 06
(b) Explain Investigation of medicinal products dossier (IMPD). 05
(c) Explain Guidelines of ICH-M. 05
Q.5 (a) Explain the scope of TGA regulations. Discuss the TGA guidelines for OTC 06
product.
(b) Explain export registration of pharmaceuticals in rest of world countries. 05
(c) Write a note on HIPAA. 05
Q. 6 (a) Explain pharmacovigilance safety monitoring in clinical trials. 06
(b) Write note on ANVISA. 05
(c) Describe various activity regulated by CDER. 05
Q.7 (a) Explain CFR 21(code of federal regulation). 06
(b) Discuss Drug Price Competition and Patent restoration act of 1984 and 05
WAXMAN-HATCH ACT are the same and its economics on the society is
important.
(c) Define ‘Orange Book’, ‘Green Book’ and ‘Blue Book’. Explain statistical 05
criteria for Bio-equivalence in context to orange book.
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GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM – SEMESTER–1 EXAMINATION – WINTER-2019
Subject Code:MPH104T Date: 03/01/2020
Subject Name: Regulatory Affair
Time: 02:30 PM TO 05:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Enlist types of DMF. Discuss type II DMF. 06
(b) Explain the necessity and importance of ICH M4 guidelines. 05
(c) Explain exclusivity according to Hatch Waxman act. 05
Q.2 (a) Compare and Contrast: NDA and ANDA 06
(b) Explain terms: i) CMC ii) Biowaiver 05
(c) Discuss Pharmacovigilance programs of USFDA and MHRA. 05
Q.3 (a) Discuss ICH guidelines for Pharmaceutical Development 06
(b) Discuss levels of post approval changes. 05
(c) Compare and Contrast: TGA and MHRA 05
Q.4 (a) Write a note on IMPD. 06
(b) Draw flow chart of IND Application and approval process. 05
(c) Discuss components of Investigator Brochure. 05
Q.5 (a) Discuss composition and functions of Institutional Review Board. 06
(b) Discuss components and importance of informed consent form. 05
(c) Give your comment: HIPAA implementation has increased duration and cost of 05
clinical trials.
Q. 6 (a) Compare: ANVISA and SAHPRA. 06
(b) Discuss process of reclassification of drugs from Prescription only medicine to 05
Pharmacy medicine as per MHRA.
(c) What are safety alerts and product recalls? Explain with example. 05
Q.7 (a) Who should file DMF? Discuss importance of Letter of Authorization. 06
(b) Discuss concept of Para I to IV filing as per USFDA. 05
(c) Discuss clinical trial requirements for pediatric products. 05
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GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM – SEMESTER–1 EXAMINATION – SUMMER-2019
Subject Code: MPH104T Date: 04/06/2019
Subject Name: Regulatory Affair
Time: 02:30 PM TO 05:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Explain IND submission for world wide. 06
(b) Write a note on ANDA. Explain PARA I to IV filling in ANDA. 05
(c) Give details note on NDA. 05
Q.2 (a) Define CTD and eCTD. Explain in detail. 06
(b) What is DMF? Write a note on Type of DMF. 05
(c) Explain in details Master Formula Record. (MFR). 05
Q.3 (a) Describe CFR 21 (code of federal regulation) in details. 06
(b) Explain guidelines of ICH-Q. 05
(c) Give important of CRO. What about out sourcing of BA & BE studies to CRO? 05
Q.4 (a) Explain the guideline of TGA for generic products. 06
(b) What are CMC regulatory affairs? Describe post approval regulatory affairs. 05
(c) Define orange book. Explain investigator brochure (IB). 05
Q.5 (a) What is dossier? Explain regulatory requirements of dossier for ROW countries. 06
(b) Explain regulation for combination product & medical devices in various 05
countries.
(c) Give details note on MHRA. 05
Q. 6 (a) Explain the various components of FDA. 06
(b) What is Post Marketing Surveillance (PMS)? Give it’s important in clinical 05
trials.
(c) How to develop clinical trials protocol at institute level? 05
Q.7 (a) Explain WAXMAN-HATCH ACT. What its economic impact on the society. 06
(b) Give in details of Pharmacovigilence safety monitoring in Clinical Trials. 05
(c) Describe HIPAA-new requirement to clinical study process. 05
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Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM – SEMESTER–1 EXAMINATION – SUMMER-2019
Subject Code: MPH104T Date: 04/06/2019
Subject Name: Regulatory Affair
Time: 02:30 PM TO 05:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Explain IND submission for world wide. 06
(b) Write a note on ANDA. Explain PARA I to IV filling in ANDA. 05
(c) Give details note on NDA. 05
Q.2 (a) Define CTD and eCTD. Explain in detail. 06
(b) What is DMF? Write a note on Type of DMF. 05
(c) Explain in details Master Formula Record. (MFR). 05
Q.3 (a) Describe CFR 21 (code of federal regulation) in details. 06
(b) Explain guidelines of ICH-Q. 05
(c) Give important of CRO. What about out sourcing of BA & BE studies to CRO? 05
Q.4 (a) Explain the guideline of TGA for generic products. 06
(b) What are CMC regulatory affairs? Describe post approval regulatory affairs. 05
(c) Define orange book. Explain investigator brochure (IB). 05
Q.5 (a) What is dossier? Explain regulatory requirements of dossier for ROW countries. 06
(b) Explain regulation for combination product & medical devices in various 05
countries.
(c) Give details note on MHRA. 05
Q. 6 (a) Explain the various components of FDA. 06
(b) What is Post Marketing Surveillance (PMS)? Give it’s important in clinical 05
trials.
(c) How to develop clinical trials protocol at institute level? 05
Q.7 (a) Explain WAXMAN-HATCH ACT. What its economic impact on the society. 06
(b) Give in details of Pharmacovigilence safety monitoring in Clinical Trials. 05
(c) Describe HIPAA-new requirement to clinical study process. 05
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GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM – SEMESTER–1 EXAMINATION – SUMMER-2020
Subject Code:MPH104T Date: 07/11/2020
Subject Name: Regulatory Affair
Time: 10:30 AM TO 1:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Describe objectives, provision and loopholes of the Hatch-Waxman 06
Act.
(b) Define DMF. Classify types of DMF. 05
(c) Explain in brief about list of table content of CFR. 05
Q.2 (a) Describe goal of ANDA. Discuss ANDA review process. 06
(b) Write a note on Post marketing surveillance and pharmaceuticals. 05
(c) Enlist contents of IND. Describe withdrawal process of IND. 05
Q.3 (a) Explain master formula record and distribution records. 06
(b) Classify NDA. Discuss regulatory requirements for NDA. 05
(c) Discuss regulatory requirements of EU. 05
Q.4 (a) Describe CTD and eCTD format and its usefulness in regulatory affairs. 06
(b) Explain Investigation of medicinal products dossier (IMPD). 05
(c) Describe responsibilities and priority of MHRA. 05
Q.5 (a) Explain scope of TGA. Discuss TGA’s approach to compliance. 06
(b) Write a note on institutional review board for clinical trials 05
(c) What is ICH? Explain ICH M in brief. 05
Q. 6 (a) Discuss regulatory system for approval of drug product for ROW countires. 06
(b) Discuss concept of Para I to IV in ANDA. 05
(c) Write a note on HIPAA and its usefulness in clinical trials. 05
Q.7 (a) Write in detail about the developing of clinical trials protocols. 06
(b) Enumerate ICH quality guidelines. Discuss about ICH Q7. 05
(c) Write a note on investigator brochure. 05
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GUJARAT TECHNOLOGICAL UNIVERSITY
M. Ph. SEMESTER–I • EXAMINATION – WINTER -2021
Subject Code: MPH104T Date: 16/03/2022
Subject Name: REGULATORY AFFAIRS
Time: 10:30AM to 01:30PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Discuss about drug master file in detail. 06
(b) Write short note on MHRA. 05
(c) Explain regulatory requirements of TGA. 05
Q.2 (a) Describe Hatch- Waxman act and its amendments in detail. 06
(b) Explain PARA I to IV filling in ANDA. 05
(c) Write note on clinical protocol at institutional level. 05
Q.3 (a) Discuss regulatory requirements for Investigational Medicinal Product Dossier 06
(IMPD)
(b) Give in details of Pharmacovigilence safety monitoring in Clinical Trials. 05
(c) Write short note on FDA components. 05
Q.4 (a) Discuss CTD and eCTD in detail. 06
(b) Write note on guideline of ICH-M. 05
(c) Write note on ANVISA. 05
Q.5 (a) Explain ANDA regulatory approval process in detail. 06
(b) Write short on HIPAA. 05
(c) Describe contents of Investigator brochure used in clinical trial. 05
Q. 6 (a) Explain code of federal regulation (CFR) 21. 06
(b) Write short note on CMC. 05
(c) Write a note on Post Marketing Surveillance. 05
Q.7 (a) Describe specific requirements and contents of an NDA. 06
(b) Discuss outsourcing BA and BE to CRO. 05
(c) Write the importance of informed Consent process. 05
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GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharm – Sem–I EXAMINATION-WINTER -2022
Subject Code:MPH104T Date:06/04/2023
Subject Name: Regulatory Affairs
Time: 02:30PM TO 05:30PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) What is MFR? Describe component of MFR. 06
(b) Define DMF. Classify types of DMF. 05
(c) Explain pharmacovigilance safety monitoring in clinical trials. 05
Q.2 (a) Describe objectives of ANDA. Explain submission process of ANDA. 06
(b) Write a note Post marketing surveillance. 05
(c) Describe responsibilities and priority of MHRA. 05
Q.3 (a) What is outsourcing of BA and BE to CRO? Discuss advantages and problems 06
of outsourcing.
(b) Classify NDA. Discuss regulatory requirements for NDA. 05
(c) Enumerate regulatory requirements of TGA. 05
Q.4 (a) What is the purpose and security rules of HIPAA. 06
(b) Write a note on Investigation of medicinal products dossier (IMPD). 05
(c) Differentiate CTD and eCTD. 05
Q.5 (a) Describe role of European Union in regulating Pharmaceutical Products. 06
(b) Write a note on constitution and functions of institutional review board for 05
clinical trials.
(c) What is ICH? Explain guidelines of ICH-Q. 05
Q. 6 (a) Discuss regulatory system for approval of drug product for ROW countries. 06
(b) Define Generic drug product. Explain process of Generic drug product 05
development.
(c) Write a note on Investigator Brochure. 05
Q.7 (a) Enlist contents of IND. Describe withdrawal process of IND. 06
(b) Write a note on ICH safety guidelines. 05
(c) Define CFR. Explain in brief about CFR structure. 05
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GUJARAT TECHNOLOGICAL UNIVERSITY
M. Ph. – SEMESTER– I • EXAMINATION – SUMMER -2022
Subject Code: MPH104T Date: 09/09/2022
Subject Name: Regulatory Affairs
Time: 10:30am to 01:30pm Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Describe the procedure for New drug approval from CDSCO in India. 06
(b) Describe rational, purpose and scope of medical device GHTF guidelines. 05
(c) Describe general consideration, specific requirements and contents of an 05
ANDA.
Q.2 (a) Discuss the regulatory requirements for Oral Combination Products in USA. 06
(b) Describe about Post marketing surveillance procedure as per EU. 05
(c) Discuss about regulatory requirements for Generic drug approval process in 05
India.
Q.3 (a) Explain the purpose and procedure for IND application to USFDA. 06
(b) Discuss about Post-market vigilance and monitoring requirements for medical 05
devices as per TGA.
(c) Discuss about Hatch Waxman act. 05
Q.4 (a) Describe the organization chart, structure and activity of MHRA. 06
(b) Discuss about general requirements for 510(k) application for Biologics as per 05
USA.
(c) Discuss role and responsibility of CMC regulatory. 05
Q.5 (a) Discuss about 21 CFR Part 211 for packaging and labeling requirements of 06
finished Pharmaceuticals.
(b) Discuss regulatory requirements for registration of API in EU. 05
(c) Briefly explain about ICH guideline M8 for eCTD submission. 05
Q. 6 (a) Explain outsourcing BA and BE to CRO. 06
(b) Explain in brief pharmacovigilance safety monitoring in clinical trials. 05
(c) Prepare Checklist for HIPAA Compliance. 05
Q.7 (a) Discuss about ICH guideline E6 Good Clinical Practice. 06
(b) Describe contents of Investigator brochure used in clinical trial. 05
(c) Discuss regulatory requirements for Investigational Medicinal Product Dossier 05
(IMPD).
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Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Ph. – SEMESTER– I • EXAMINATION – SUMMER -2022
Subject Code: MPH104T Date: 09/09/2022
Subject Name: Regulatory Affairs
Time: 10:30am to 01:30pm Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Describe the procedure for New drug approval from CDSCO in India. 06
(b) Describe rational, purpose and scope of medical device GHTF guidelines. 05
(c) Describe general consideration, specific requirements and contents of an 05
ANDA.
Q.2 (a) Discuss the regulatory requirements for Oral Combination Products in USA. 06
(b) Describe about Post marketing surveillance procedure as per EU. 05
(c) Discuss about regulatory requirements for Generic drug approval process in 05
India.
Q.3 (a) Explain the purpose and procedure for IND application to USFDA. 06
(b) Discuss about Post-market vigilance and monitoring requirements for medical 05
devices as per TGA.
(c) Discuss about Hatch Waxman act. 05
Q.4 (a) Describe the organization chart, structure and activity of MHRA. 06
(b) Discuss about general requirements for 510(k) application for Biologics as per 05
USA.
(c) Discuss role and responsibility of CMC regulatory. 05
Q.5 (a) Discuss about 21 CFR Part 211 for packaging and labeling requirements of 06
finished Pharmaceuticals.
(b) Discuss regulatory requirements for registration of API in EU. 05
(c) Briefly explain about ICH guideline M8 for eCTD submission. 05
Q. 6 (a) Explain outsourcing BA and BE to CRO. 06
(b) Explain in brief pharmacovigilance safety monitoring in clinical trials. 05
(c) Prepare Checklist for HIPAA Compliance. 05
Q.7 (a) Discuss about ICH guideline E6 Good Clinical Practice. 06
(b) Describe contents of Investigator brochure used in clinical trial. 05
(c) Discuss regulatory requirements for Investigational Medicinal Product Dossier 05
(IMPD).
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GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM – SEMESTER–1 EXAMINATION – SUMMER -2023
Subject Code: MPH104T Date: 11-08-2023
Subject Name: Regulatory Affairs
Time: 02:30 PM TO 05:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Give structure and functions of Institutional Review Board. 06
(b) Give importance of informed consent in clinical trials. 05
(c) Discuss importance of independent ethics committee in non clinical research. 05
Q.2 (a) Discuss the stages of New Drug Approval process of USFDA. 06
(b) Discuss data sought by EMA for clinical trial of investigational medicinal 05
product under test.
(c) Discuss elements of pharmaceutical development according to ICH Q8(R2) 05
guidelines.
Q.3 (a) Enlist types of DMF. Who should file DMF? Discuss its importance. 06
(b) Write a note on ANVISA. 05
(c) Discuss components of Investigator’s Brochure. 05
Q.4 (a) Compare and Contrast: IND and ANDA. 06
(b) Discuss SUPAC guidelines for release controlling excipients in modified 05
release solid oral dosage forms.
(c) Discuss impact of Hatch Waxman act on Generic drug development. 05
Q.5 (a) Discuss ICH M8 Guidelines. 06
(b) Compare regulatory requirements of Australia and European Union. 05
(c) Give your comments: 05
i) MHRA is the only regulatory agency controlling British healthcare
system.
ii) SAHPRA regulates healthcare products in Brazil.
Q. 6 (a) Explain the terms in brief : i) CRO ii) CFR iii) CTD 06
(b) Give your comments: 05
i) Bio-equivalence studies ease drug approval process.
ii) Phase IV clinical studies are not done in India.
(c) Enlist types of exclusivity. Discuss any two in detail. 05
Q.7 (a) What is Orange book? What is RLD? What is difference between therapeutic 06
equivalence and therapeutic alternative?
(b) Write a note on IIG. 05
(c) Discuss the concept of Para I to IV filing. 05
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