Vaccine regulations: clinical evaluation, marketing authorisation and pharmacovigilance (IN/US/EU) MCQs With Answer

Vaccine regulations: clinical evaluation, marketing authorisation and pharmacovigilance (IN/US/EU) MCQs With Answer

This set of multiple-choice questions is designed for M.Pharm students studying Regulatory Aspects of Herbal and Biologicals (MRA202T). It focuses on clinical evaluation, regulatory pathways for marketing authorisation, and pharmacovigilance requirements for vaccines across India, the United States, and the European Union. Questions emphasize practical regulatory concepts: trial phases and designs for immunogenicity and efficacy, national and regional approval routes (including emergency/conditional pathways), post-marketing safety systems, reporting timelines, and risk-management tools. Use these MCQs to test and deepen your understanding of regulatory expectations for vaccines and to prepare for examinations and applied regulatory work.

Q1. Which US regulatory center is primarily responsible for vaccines?

• Center for Drug Evaluation and Research (CDER)
• Center for Biologics Evaluation and Research (CBER)
• European Medicines Agency (EMA)
• Central Drugs Standard Control Organization (CDSCO)

Correct Answer: Center for Biologics Evaluation and Research (CBER)

Q2. Which EMA committee provides the scientific opinion for centralized marketing authorisation of vaccines in the EU?

• Pharmacovigilance Risk Assessment Committee (PRAC)
• Committee for Orphan Medicinal Products (COMP)
• Committee for Medicinal Products for Human Use (CHMP)
• Pediatric Committee (PDCO)

Correct Answer: Committee for Medicinal Products for Human Use (CHMP)

Q3. In India, which office/authority issues marketing authorisation for vaccines?

• Indian Council of Medical Research (ICMR)
• Drug Controller General of India (DCGI)
• Ministry of Health and Family Welfare (MoHFW) only
• National Immunization Technical Advisory Group (NITAG)

Correct Answer: Drug Controller General of India (DCGI)

Q4. Which regulatory pathway in the US authorises use of a vaccine during a public health emergency without a full biologics licence?

• Biologics License Application (BLA)
• Emergency Use Authorization (EUA)
• Fast Track Designation
• Accelerated Approval

Correct Answer: Emergency Use Authorization (EUA)

Q5. Which EU marketing authorisation mechanism allows conditional approval of a vaccine when comprehensive data are not yet available?

• National Competent Authority Approval
• Mutual Recognition Procedure
• Conditional Marketing Authorisation (CMA)
• Decentralized Procedure

Correct Answer: Conditional Marketing Authorisation (CMA)

Q6. Which clinical trial phase typically focuses on immunogenicity, dose-ranging and preliminary safety for vaccines?

• Phase I
• Phase II
• Phase III
• Phase IV

Correct Answer: Phase II

Q7. What is the primary objective of a bridging study in vaccine development?

• To compare manufacturing sites only
• To extrapolate immunogenicity/safety data between different populations or formulations
• To replace a full Phase III efficacy trial
• To test storage conditions

Correct Answer: To extrapolate immunogenicity/safety data between different populations or formulations

Q8. Which trial design is commonly used for comparative vaccine studies when demonstrating comparable immune response is acceptable?

• Superiority trial
• Non-inferiority trial
• Equivalence trial
• Case-control study

Correct Answer: Non-inferiority trial

Q9. In vaccine regulatory science, a “correlate of protection” refers to:

• A regulatory approval pathway for fast authorisation
• A manufacturing release test for each lot
• A specific immune marker predictive of clinical protection
• A type of adverse event reported post-marketing

Correct Answer: A specific immune marker predictive of clinical protection

Q10. Who typically performs official lot release testing of vaccines before distribution?

• Manufacturer’s in-house quality control only
• Independent contract research organisation (CRO)
• National control laboratory / official national testing laboratory
• Clinical trial site laboratories

Correct Answer: National control laboratory / official national testing laboratory

Q11. Which US system is the primary passive national reporting system for vaccine adverse events?

• Vaccine Safety Datalink (VSD)
• Vaccine Adverse Event Reporting System (VAERS)
• EudraVigilance
• Pharmacovigilance Programme of India (PvPI)

Correct Answer: Vaccine Adverse Event Reporting System (VAERS)

Q12. Which database is the European system for collecting and analysing suspected adverse reactions to medicines, including vaccines?

• EudraVigilance
• Vaccine Adverse Event Reporting System (VAERS)
• Pharmacovigilance Programme of India (PvPI)
• MedWatch

Correct Answer: EudraVigilance

Q13. What is the national pharmacovigilance program in India that collects adverse drug and vaccine reactions?

• Vaccine Safety Datalink (VSD)
• Pharmacovigilance Programme of India (PvPI)
• European Pharmacovigilance Network
• MedWatch

Correct Answer: Pharmacovigilance Programme of India (PvPI)

Q14. Under ICH guidance E2C(R2), which report is intended for periodic benefit-risk evaluation of an approved medicinal product?

• Periodic Safety Update Report (PSUR)
• Periodic Benefit-Risk Evaluation Report (PBRER)
• Risk Management Plan (RMP)
• Risk Evaluation and Mitigation Strategy (REMS)

Correct Answer: Periodic Benefit-Risk Evaluation Report (PBRER)

Q15. Which document outlines planned pharmacovigilance activities and risk minimisation measures for a medicine in the EU?

• Periodic Safety Update Report (PSUR)
• Biologics License Application (BLA)
• Risk Management Plan (RMP)
• Investigator’s Brochure (IB)

Correct Answer: Risk Management Plan (RMP)

Q16. Which US regulatory tool is comparable to the EU Risk Management Plan for imposing post-marketing safety requirements?

• Periodic Benefit-Risk Evaluation Report (PBRER)
• Risk Evaluation and Mitigation Strategy (REMS)
• Marketing Authorisation Application (MAA)
• Clinical Trial Application (CTA)

Correct Answer: Risk Evaluation and Mitigation Strategy (REMS)

Q17. According to ICH expedited reporting guidance, what is the initial reporting timeline for a fatal or life‑threatening suspected unexpected serious adverse reaction (SUSAR)?

• 24 hours
• 7 calendar days
• 15 calendar days
• 30 calendar days

Correct Answer: 7 calendar days

Q18. Which phase of clinical research corresponds to post-marketing surveillance and additional safety/effectiveness studies for vaccines?

• Phase I
• Phase II
• Phase III
• Phase IV

Correct Answer: Phase IV

Q19. What regulatory submission is required in the US to obtain full marketing approval for a vaccine as a biological product?

• New Drug Application (NDA)
• Abbreviated New Drug Application (ANDA)
• Biologics License Application (BLA)
• Marketing Authorisation Application (MAA)

Correct Answer: Biologics License Application (BLA)

Q20. Which statement best describes the rationale for granting a Conditional Marketing Authorisation (CMA) in the EU for a vaccine?

• Comprehensive long-term efficacy and safety data are fully available before approval
• The product addresses an unmet medical need and benefit outweighs the risk despite incomplete data
• It is reserved for generics of well-established vaccines
• CMA is issued only for veterinary vaccines

Correct Answer: The product addresses an unmet medical need and benefit outweighs the risk despite incomplete data

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