Historical overview and evolution of regulatory affairs MCQs With Answer

Historical overview and evolution of regulatory affairs MCQs With Answer

Regulatory affairs in pharmaceuticals trace centuries of public health advances, policies and responses to safety crises. This introduction covers the evolution from early laws like the 1906 Pure Food and Drug Act to modern harmonization efforts such as ICH, the role of agencies (FDA, EMA, CDSCO), key milestones like the 1938 FD&C Act and the 1962 Kefauver-Harris amendments, and practices including GMP, GLP, GCP, CTD and pharmacovigilance. B.Pharm students will benefit by understanding how regulatory frameworks ensure drug safety, efficacy, quality, approval pathways, dossier preparation and post-marketing surveillance. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of regulatory affairs in the pharmaceutical industry?

• To design clinical trial protocols
• To ensure compliance with laws and ensure safety, quality and efficacy of medicines
• To manufacture active pharmaceutical ingredients
• To market medicines directly to patients

Correct Answer: To ensure compliance with laws and ensure safety, quality and efficacy of medicines

Q2. Which early U.S. law marked a key beginning of modern drug regulation in 1906?

• Food, Drug and Cosmetic Act
• Pure Food and Drug Act
• Kefauver-Harris Amendment
• Federal Food Safety Act

Correct Answer: Pure Food and Drug Act

Q3. The 1938 Federal Food, Drug, and Cosmetic (FD&C) Act was enacted mainly because of which public health disaster?

• Thalidomide birth defects
• Elixir Sulfanilamide poisoning
• Warped sulfa synthesis
• Contaminated vaccines

Correct Answer: Elixir Sulfanilamide poisoning

Q4. Which event prompted the 1962 Kefauver-Harris Amendments focused on drug efficacy and safety?

• Industrial chemical spill
• Thalidomide-induced birth defects
• Influenza pandemic
• Talcum powder contamination

Correct Answer: Thalidomide-induced birth defects

Q5. Which agency is the central regulatory authority for drugs in India?

• FDA
• EMA
• CDSCO
• MHRA

Correct Answer: CDSCO

Q6. What does ICH stand for in international pharmaceutical regulation?

• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
• International Committee for Health
• Institute of Clinical Harmonization
• International Code for Health

Correct Answer: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Q7. The Common Technical Document (CTD) primarily facilitates what in regulatory submissions?

• Local manufacturing processes
• Harmonized dossier submission across regions
• Marketing strategies for drugs
• Hospital formulary approvals

Correct Answer: Harmonized dossier submission across regions

Q8. Which ICH guideline is specifically about Good Clinical Practice?

• ICH Q1
• ICH E6
• ICH Q7
• ICH M4

Correct Answer: ICH E6

Q9. What is the primary focus of Good Manufacturing Practice (GMP)?

• Ensuring laboratory data integrity only
• Ensuring that products are consistently produced and controlled to quality standards
• Designing clinical trials
• Advertising compliance

Correct Answer: Ensuring that products are consistently produced and controlled to quality standards

Q10. Which document section of the CTD contains summaries and overviews of quality, nonclinical and clinical data?

• Module 1
• Module 2
• Module 3
• Module 5

Correct Answer: Module 2

Q11. What is pharmacovigilance primarily concerned with?

• Drug marketing analytics
• Monitoring, detecting and preventing adverse drug reactions post-marketing
• Drug manufacturing scale-up
• Clinical trial recruitment

Correct Answer: Monitoring, detecting and preventing adverse drug reactions post-marketing

Q12. The “Yellow Card” scheme for reporting adverse drug reactions was established in which country as a response to safety issues?

• United Kingdom
• United States
• India
• Japan

Correct Answer: United Kingdom

Q13. Which ICH guideline series addresses stability testing of new drug substances and products?

• Q series
• E series
• M series
• S series

Correct Answer: Q series

Q14. What is the main purpose of an Investigational New Drug (IND) application?

• To obtain marketing approval
• To gain permission to start clinical trials in humans
• To register manufacturing sites only
• To submit post-marketing safety reports

Correct Answer: To gain permission to start clinical trials in humans

Q15. Which regulatory document outlines acceptable practices for non-clinical laboratory studies?

• GCP
• GLP
• GMP
• GDP

Correct Answer: GLP

Q16. In regulatory terminology, what does a Marketing Authorization Application (MAA) or New Drug Application (NDA) request?

• Approval to begin animal studies
• Permission to market a medicinal product
• Authorization for advertising campaigns
• Registration of clinical trial volunteers

Correct Answer: Permission to market a medicinal product

Q17. Which ICH guideline is focused on quality risk management?

• ICH Q9
• ICH E2
• ICH Q1
• ICH M1

Correct Answer: ICH Q9

Q18. What key benefit does international regulatory harmonization bring?

• Increases country-specific paperwork
• Reduces duplication, facilitates global drug development and speeds access to medicines
• Removes the need for quality standards
• Eliminates clinical trials

Correct Answer: Reduces duplication, facilitates global drug development and speeds access to medicines

Q19. Which of the following is part of a regulatory dossier’s quality section?

• Clinical study reports
• Pharmacokinetic analyses
• Manufacturing process and controls, specifications and stability data
• Informed consent forms

Correct Answer: Manufacturing process and controls, specifications and stability data

Q20. What is the role of an Ethics Committee or Institutional Review Board in trials?

• Manufacture investigational products
• Review and approve protocols to protect participant rights and safety
• Market approved drugs
• Write clinical trial protocols for sponsors

Correct Answer: Review and approve protocols to protect participant rights and safety

Q21. Which guideline group provides standards for Good Distribution Practice for medicinal products?

• ICH
• WHO and regional regulators
• Pharmacopoeias only
• Clinical trial monitors

Correct Answer: WHO and regional regulators

Q22. What does Schedule M of the Drugs and Cosmetics Rules (India) primarily relate to?

• Clinical trial recruitment
• Good Manufacturing Practices for pharmaceutical manufacturing
• Pharmacovigilance reporting formats
• Import tariffs for APIs

Correct Answer: Good Manufacturing Practices for pharmaceutical manufacturing

Q23. Which of the following best describes Quality by Design (QbD) in regulatory context?

• Randomized production without documentation
• Building quality into product and process design using scientific understanding and risk management
• Marketing strategy for product launch
• Outsourcing all quality activities

Correct Answer: Building quality into product and process design using scientific understanding and risk management

Q24. Which international pharmacopoeia is commonly used as a reference for drug quality standards?

• Indian Pharmacopoeia (IP)
• British Pharmacopoeia (BP)
• United States Pharmacopeia (USP)
• All of the above depending on region

Correct Answer: All of the above depending on region

Q25. What is a Risk Management Plan (RMP) in pharmacovigilance?

• A manufacturing batch record
• A proactive plan to identify, characterize and minimize risks associated with a medicinal product
• An advertising consent form
• A clinical trial randomization schedule

Correct Answer: A proactive plan to identify, characterize and minimize risks associated with a medicinal product

Q26. Which regulator introduced the modern concept of requiring both safety and efficacy data before drug approval?

• Food and Drug Administration (FDA) via Kefauver-Harris Amendments
• World Health Organization only
• Indian Ministry of Health exclusively
• Clinical trial sponsors

Correct Answer: Food and Drug Administration (FDA) via Kefauver-Harris Amendments

Q27. Post-marketing surveillance primarily aims to detect what that pre-marketing trials may miss?

• Manufacturing costs
• Rare, long-term or population-specific adverse events
• Marketing opportunities
• Packaging defects only

Correct Answer: Rare, long-term or population-specific adverse events

Q28. Which module of the CTD contains detailed clinical study reports?

• Module 3
• Module 4
• Module 5
• Module 1

Correct Answer: Module 5

Q29. Which regulatory pathway is often used to speed approval for drugs addressing unmet medical needs?

• Standard review only
• Accelerated approval or priority review pathways
• Routine manufacturing inspection
• Postponed review

Correct Answer: Accelerated approval or priority review pathways

Q30. Why is knowledge of regulatory affairs important for B.Pharm graduates?

• Only for marketing jobs
• To understand drug development, ensure compliance, support approvals, and protect public health
• To avoid learning scientific principles
• To replace clinical researchers

Correct Answer: To understand drug development, ensure compliance, support approvals, and protect public health

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com