Regulations for drugs, biologics and medical devices MCQs With Answer

Introduction: This blog offers a focused set of MCQs on regulations governing drugs, biologics and medical devices tailored for M.Pharm students preparing for exams and professional practice. Questions cover national and international regulatory frameworks, application types (IND, NDA, BLA, ANDA, PMA, 510(k)), ICH guidances, clinical trial requirements, pharmacovigilance, biosimilar principles, device classification and quality systems (GMP/GLP/GCP, ISO 13485). Each MCQ includes plausible distractors and clear answers to help students test deeper understanding of regulatory strategy, approval pathways, post-marketing surveillance and documentation needed for regulatory submissions. Use these to consolidate conceptual knowledge and exam readiness.

Q1. Which authority is the primary national regulator for approval of drugs and clinical trial oversight in India?

• Food and Drug Administration (FDA)
• Central Drugs Standard Control Organization (CDSCO)
• European Medicines Agency (EMA)
• International Council for Harmonisation (ICH)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q2. Which regulatory submission is required in the United States to begin clinical trials of an investigational new drug?

• New Drug Application (NDA)
• Abbreviated New Drug Application (ANDA)
• Investigational New Drug application (IND)
• Biologics License Application (BLA)

Correct Answer: Investigational New Drug application (IND)

Q3. For full marketing approval of a therapeutic biologic in the US, which application is submitted to the FDA?

• New Drug Application (NDA)
• Abbreviated New Drug Application (ANDA)
• Biologics License Application (BLA)
• Premarket Approval (PMA)

Correct Answer: Biologics License Application (BLA)

Q4. The FDA 510(k) premarket notification is primarily intended to demonstrate which of the following?

• The device meets international quality management standards
• Substantial equivalence to a legally marketed predicate device
• Complete clinical trial data proving safety and efficacy
• That the device is classified as a biologic

Correct Answer: Substantial equivalence to a legally marketed predicate device

Q5. Which ICH guideline is the recognised standard for Good Clinical Practice?

• ICH Q1A (Stability)
• ICH E3 (Clinical Study Report)
• ICH E6 (Good Clinical Practice)
• ICH Q7 (API GMP)

Correct Answer: ICH E6 (Good Clinical Practice)

Q6. Under Indian Medical Device Rules, which risk class represents the highest risk devices (e.g., implantable pacemaker)?

• Class A
• Class B
• Class C
• Class D

Correct Answer: Class D

Q7. What is the main purpose of an Abbreviated New Drug Application (ANDA)?

• Approval for a new chemical entity with full clinical data
• Marketing approval for a generic drug demonstrating bioequivalence
• Approval for a biologic product through comparability studies
• Permission to begin human clinical trials

Correct Answer: Marketing approval for a generic drug demonstrating bioequivalence

Q8. Which periodic safety report format introduced by ICH replaces older PSURs and focuses on benefit-risk evaluation?

• DSUR (Development Safety Update Report)
• PBRER (Periodic Benefit-Risk Evaluation Report)
• RMP (Risk Management Plan)
• IND Annual Report

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

Q9. Which accelerated approval pathway in the US allows marketing based on a surrogate endpoint reasonably likely to predict clinical benefit for serious conditions?

• Fast Track designation
• Breakthrough Therapy designation
• Accelerated Approval
• Priority Review

Correct Answer: Accelerated Approval

Q10. Which of the following is NOT typically required to obtain regulatory approval for a biosimilar?

• Extensive analytical comparability and quality characterization
• Comparative nonclinical and clinical studies to demonstrate similarity
• Automatic interchangeability designation without additional data
• Pharmacovigilance and post-marketing monitoring plans

Correct Answer: Automatic interchangeability designation without additional data

Q11. Which ICH guideline provides the core recommendations for stability testing of new drug substances and products?

• ICH Q1A (R2) Stability Testing of New Drug Substances and Products
• ICH Q3A (Impurities)
• ICH Q5C (Biotechnology Stability)
• ICH M4 (CTD Format)

Correct Answer: ICH Q1A (R2) Stability Testing of New Drug Substances and Products

Q12. Which international standard is most relevant for a medical device manufacturer’s quality management system?

• ISO 9001
• ISO 13485
• ISO 14001
• ISO 14971

Correct Answer: ISO 13485

Q13. Which ICH guidance sets out good manufacturing practice for active pharmaceutical ingredients (APIs)?

• ICH Q8 (Pharmaceutical Development)
• ICH Q7 (Good Manufacturing Practice for APIs)
• ICH Q9 (Quality Risk Management)
• ICH Q10 (Pharmaceutical Quality System)

Correct Answer: ICH Q7 (Good Manufacturing Practice for APIs)

Q14. In India, which schedule of the Drugs and Cosmetics Rules outlines requirements for clinical trial conduct and approvals?

• Schedule M
• Schedule Y
• Schedule D
• Schedule L

Correct Answer: Schedule Y

Q15. Orphan drug designation in the United States is applicable to diseases affecting fewer than how many people in the US?

• 50,000
• 100,000
• 200,000
• 500,000

Correct Answer: 200,000

Q16. What does FDA Premarket Approval (PMA) primarily require for high‑risk medical devices?

• Only bench testing and labeling review
• Demonstration of substantial equivalence to a predicate device
• Valid scientific evidence, typically including clinical data, of safety and effectiveness
• Self-declaration of conformity to ISO standards

Correct Answer: Valid scientific evidence, typically including clinical data, of safety and effectiveness

Q17. Under ICH/ICH GCP expedited reporting rules, what is the required timeline for reporting a fatal or life‑threatening SUSAR to regulatory authorities?

• Within 24 hours
• Within 7 calendar days
• Within 30 calendar days
• Within 90 days

Correct Answer: Within 7 calendar days

Q18. Which document provides investigators with a comprehensive summary of preclinical and clinical information about an investigational product?

• Investigator’s Brochure
• Clinical Study Report
• Plain Language Summary
• Material Safety Data Sheet (MSDS)

Correct Answer: Investigator’s Brochure

Q19. Which regulatory procedure enables a single marketing authorization valid across all EU member states for certain medicines?

• Decentralized Procedure
• Mutual Recognition Procedure
• Centralized Procedure via the European Medicines Agency (EMA)
• National Procedure

Correct Answer: Centralized Procedure via the European Medicines Agency (EMA)

Q20. On what primary basis do regulators accept assignment of product shelf-life in a marketing application?

• Manufacturer’s internal estimate without experimental data
• Accelerated stability data alone
• Real-time long-term stability data supported by accelerated studies
• Comparative dissolution testing only

Correct Answer: Real-time long-term stability data supported by accelerated studies

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