Overview of regulatory approval processes MCQs With Answer

Overview of regulatory approval processes MCQs With Answer — Introduction

This concise overview for B. Pharm students covers regulatory approval processes, explaining regulatory authorities (FDA, EMA, CDSCO), drug development stages, clinical trial phases, dossier formats (CTD/eCTD), NDA and ANDA submissions, bioequivalence, Good Manufacturing Practices (GMP), pharmacovigilance, stability studies, and post-marketing surveillance. Emphasis on regulatory guidelines (ICH, CDSCO), dossier preparation, inspection readiness, and ethical requirements prepares students for careers in regulatory affairs, quality assurance, clinical research, and drug safety. Practical insights into submission timelines, accelerated pathways, and common deficiencies will strengthen decision-making and professional competence. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which module of the Common Technical Document (CTD) contains quality (chemical, manufacturing and control) information for a drug product?

• Module 1
• Module 2
• Module 3
• Module 4

Correct Answer: Module 3

Q2. What is the primary purpose of an Investigational New Drug (IND) application?

• To obtain marketing approval for a new drug
• To request orphan drug designation
• To obtain authorization to start clinical trials in humans
• To register a manufacturing site

Correct Answer: To obtain authorization to start clinical trials in humans

Q3. Which regulatory submission is typically used for approval of a generic pharmaceutical product in many jurisdictions?

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

Correct Answer: ANDA (Abbreviated New Drug Application)

Q4. In clinical development, which phase primarily assesses safety and tolerability in a small number of healthy volunteers?

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

Correct Answer: Phase I

Q5. Which guideline series provides harmonized technical requirements for pharmaceutical product registration among major regions?

• GMP Guidelines
• ICH Guidelines
• WHO Prequalification Guidelines
• Pharmacopoeial Monographs

Correct Answer: ICH Guidelines

Q6. Which document provides detailed clinical study reports and nonclinical study reports in the CTD?

• Module 1
• Module 2
• Module 4
• Module 5

Correct Answer: Module 4

Q7. What is bioequivalence primarily intended to demonstrate for generic products?

• Different formulation is superior
• Same therapeutic efficacy and safety as reference product when administered at the same molar dose
• Lower manufacturing cost
• Improved patient compliance

Correct Answer: Same therapeutic efficacy and safety as reference product when administered at the same molar dose

Q8. Which regulatory authority is the central body responsible for drug approval in India?

• FDA (Food and Drug Administration)
• EMA (European Medicines Agency)
• CDSCO (Central Drugs Standard Control Organization)
• MHRA (Medicines and Healthcare products Regulatory Agency)

Correct Answer: CDSCO (Central Drugs Standard Control Organization)

Q9. Which of the following is a key component of Quality by Design (QbD) in pharmaceutical development?

• Ignoring variability in raw materials
• Defining a design space and identifying critical quality attributes
• Minimizing process understanding to speed approval
• Focusing only on end-product testing

Correct Answer: Defining a design space and identifying critical quality attributes

Q10. During regulatory inspection, which documentation is most critical to demonstrate GMP compliance?

• Product marketing brochures
• Batch manufacturing records and quality control records
• Employee resumes only
• Clinical trial participant lists

Correct Answer: Batch manufacturing records and quality control records

Q11. Which expedited regulatory pathway is used to accelerate development and review of drugs for serious conditions with preliminary clinical evidence of substantial improvement?

• Standard review
• Fast Track designation
• Compassionate use
• Orphan drug designation

Correct Answer: Fast Track designation

Q12. In an eCTD submission, what is the main advantage compared to paper CTD?

• Requires more paper documents
• Facilitates electronic lifecycle management and regulatory review
• Eliminates need for Module 3
• Reduces the need for clinical data

Correct Answer: Facilitates electronic lifecycle management and regulatory review

Q13. Which study is essential to establish shelf life and storage conditions for a drug product?

• Bioequivalence study
• Stability study
• Phase III efficacy study
• Adverse event monitoring study

Correct Answer: Stability study

Q14. What is the principal regulatory concern addressed by pharmacovigilance post-marketing?

• Marketing strategies
• Ongoing detection and evaluation of adverse drug reactions and safety signals
• Patent protection
• Clinical trial recruitment

Correct Answer: Ongoing detection and evaluation of adverse drug reactions and safety signals

Q15. Which application type is typically required for biological products like monoclonal antibodies in the US?

• ANDA
• NDA
• BLA (Biologics License Application)
• MAA

Correct Answer: BLA (Biologics License Application)

Q16. What is an Investigator’s Brochure (IB) used for in clinical research?

• To provide marketing materials for sales teams
• To summarize clinical and nonclinical data relevant to the study for investigators
• To report final marketing approval only
• To certify GMP compliance

Correct Answer: To summarize clinical and nonclinical data relevant to the study for investigators

Q17. Which of the following best describes an Abbreviated New Drug Application (ANDA) requirement for clinical data?

• Full clinical trial program identical to the innovator
• No requirement for bioavailability or bioequivalence studies
• Demonstration of bioequivalence to the reference listed drug instead of full clinical trials
• Only animal studies are required

Correct Answer: Demonstration of bioequivalence to the reference listed drug instead of full clinical trials

Q18. During dossier review, what is typically considered a critical deficiency leading to a regulatory query?

• Minor formatting inconsistencies
• Missing pivotal clinical study reports or critical stability data
• Excessive packaging details
• Too many appendices

Correct Answer: Missing pivotal clinical study reports or critical stability data

Q19. What is the role of an ethics committee (IRB) in clinical trials?

• To approve marketing language
• To review and approve the ethical conduct of the trial and ensure participant protection
• To set drug prices
• To manufacture the investigational product

Correct Answer: To review and approve the ethical conduct of the trial and ensure participant protection

Q20. Which is the primary goal of Good Clinical Practice (GCP) guidelines?

• Ensure preclinical study quality only
• Protect rights, safety and well-being of trial subjects and ensure data integrity
• Define manufacturing parameters
• Provide marketing approval timelines

Correct Answer: Protect rights, safety and well-being of trial subjects and ensure data integrity

Q21. Which regulatory document contains administrative and prescribing information specific to a region?

• Module 3 dossier
• Summary of Product Characteristics (SmPC) or Product Label
• Clinical study protocol
• Analytical method validation report

Correct Answer: Summary of Product Characteristics (SmPC) or Product Label

Q22. For biosimilars, regulatory approval primarily requires demonstration of:

• Identical amino acid sequence only
• Comparability in quality, safety and efficacy to the reference biologic based on analytical, nonclinical and clinical data
• Lower manufacturing cost than reference
• No clinical or analytical data if manufacturing is same

Correct Answer: Comparability in quality, safety and efficacy to the reference biologic based on analytical, nonclinical and clinical data

Q23. What is a Drug Master File (DMF) used for?

• To register clinical sites
• To provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging or storing of drugs
• To submit patient-level clinical data publicly
• To replace the Module 2 summary

Correct Answer: To provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging or storing of drugs

Q24. Which parameter is critical for bioequivalence study design of an immediate-release oral dosage form?

• Use of different active ingredient
• Selection of appropriate fasting and/or fed conditions and adequate sampling times to capture Tmax and Cmax
• Excluding pharmacokinetic endpoints
• Using an entirely different formulation matrix

Correct Answer: Selection of appropriate fasting and/or fed conditions and adequate sampling times to capture Tmax and Cmax

Q25. Which ICH guideline covers stability testing of new drug substances and products?

• ICH Q3
• ICH Q7
• ICH Q1
• ICH M4

Correct Answer: ICH Q1

Q26. What is the main objective of a pre-IND meeting with a regulatory authority?

• To finalize marketing claims
• To discuss planned preclinical and clinical development plans and obtain regulatory feedback
• To submit a final marketing application
• To register manufacturing sites only

Correct Answer: To discuss planned preclinical and clinical development plans and obtain regulatory feedback

Q27. Which concept refers to post-approval changes made to a drug product that must be notified or approved by regulators?

• Pharmacovigilance
• Supplement or variation submission
• Bioequivalence waiver
• Preclinical bridging

Correct Answer: Supplement or variation submission

Q28. Which of the following best describes an accelerated approval pathway?

• Approval based solely on manufacturing data
• Approval based on a surrogate or intermediate clinical endpoint reasonably likely to predict clinical benefit, with post-marketing confirmatory trials required
• Approval without any clinical evidence
• Approval only for topical products

Correct Answer: Approval based on a surrogate or intermediate clinical endpoint reasonably likely to predict clinical benefit, with post-marketing confirmatory trials required

Q29. What is the correct timeline for reporting a serious unexpected suspected adverse reaction (SUSAR) to regulatory authorities in clinical trials (general expectation)?

• Report within 30 days
• Report only at the end of the trial
• Expedited reporting within 7–15 days depending on severity
• No reporting required

Correct Answer: Expedited reporting within 7–15 days depending on severity

Q30. Which document summarizes the quality overall summary, nonclinical overview, and clinical overview in the CTD and is aimed at regulatory assessors?

• Module 3 only
• Module 2 (Quality Overall Summary, Nonclinical Overview, Clinical Overview)
• Module 1 regional forms only
• Investigators brochure

Correct Answer: Module 2 (Quality Overall Summary, Nonclinical Overview, Clinical Overview)

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