The regulatory affairs department plays a vital role in bringing safe, effective medicines to market by ensuring compliance with laws, guidelines and agency requirements. For B.Pharm students, mastering the functions and responsibilities of the regulatory affairs department MCQs With Answer builds core skills in dossier preparation (CTD/eCTD), regulatory strategy, clinical trial approvals, product registration, labeling, pharmacovigilance, post‑marketing changes, and inspection responses. Topics include CMC, stability, GMP/GCP compliance, regulatory intelligence and interactions with agencies like FDA, EMA and CDSCO. This focused knowledge prepares graduates for roles in submissions, quality systems and lifecycle management. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary function of a regulatory affairs department in a pharmaceutical company?
- Ensure products comply with regulatory requirements and obtain market authorization
- Design and scale up manufacturing processes
- Conduct routine sales and marketing activities
- Perform daily laboratory quality control tests
Correct Answer: Ensure products comply with regulatory requirements and obtain market authorization
Q2. CTD stands for which of the following?
- Central Technical Dossier
- Common Technical Document
- Clinical Trial Database
- Controlled Testing Directive
Correct Answer: Common Technical Document
Q3. What is the main purpose of the eCTD format?
- To replace manufacturing batch records
- To provide an electronic standard for regulatory submissions and lifecycle management
- To record electronic lab notebook entries
- To manage internal audit schedules
Correct Answer: To provide an electronic standard for regulatory submissions and lifecycle management
Q4. IND is an application submitted to request permission to:
- Obtain marketing exclusivity
- Start clinical trials in humans
- Register a generic product
- Export a pharmaceutical product
Correct Answer: Start clinical trials in humans
Q5. What does NDA stand for in regulatory context?
- New Drug Application
- National Drug Approval
- New Development Assessment
- Nonclinical Data Appendices
Correct Answer: New Drug Application
Q6. ANDA is primarily used for:
- Original biologic product registration
- Abbreviated New Drug Application for generics
- Clinical trial notification in Europe
- Export certificate applications
Correct Answer: Abbreviated New Drug Application for generics
Q7. Pharmacovigilance mainly involves:
- Designing clinical trial protocols
- Monitoring and managing adverse drug reactions after marketing
- Conducting stability testing
- Preparing import-export documentation
Correct Answer: Monitoring and managing adverse drug reactions after marketing
Q8. ICH Q1 guidelines are concerned with:
- Good clinical practice
- Stability testing of new drug substances and products
- Nonclinical safety testing
- Bioequivalence study design
Correct Answer: Stability testing of new drug substances and products
Q9. Which authority is the national regulatory body for pharmaceuticals in India?
- EMA
- FDA
- CDSCO
- MHRA
Correct Answer: CDSCO
Q10. How many modules are there in the Common Technical Document (CTD)?
- 3
- 4
- 5
- 6
Correct Answer: 5
Q11. Which of the following is a typical CMC responsibility handled by regulatory affairs?
- Preparing marketing campaign materials
- Documenting manufacturing process, controls and specifications
- Conducting phase IV clinical trials
- Managing hospital pharmacy inventories
Correct Answer: Documenting manufacturing process, controls and specifications
Q12. A Certificate of Pharmaceutical Product (CPP) is primarily used to:
- Prove clinical trial enrollment
- Demonstrate that a product is authorized for sale in the exporting country
- Document batch release testing
- Register trademarks internationally
Correct Answer: Demonstrate that a product is authorized for sale in the exporting country
Q13. What is a variation (or supplement) application in regulatory practice?
- An application to initiate first-in-human studies
- An application to modify an already approved marketing authorization
- An application to change clinical trial subjects
- An application to request accelerated approval
Correct Answer: An application to modify an already approved marketing authorization
Q14. Which CTD module contains clinical study reports and clinical summaries?
- Module 1
- Module 3
- Module 4
- Module 5
Correct Answer: Module 5
Q15. Which committee provides ethical approval for clinical trials at an institutional level?
- Regulatory Authority
- Institutional Ethics Committee / Institutional Review Board (IEC/IRB)
- Marketing Authorization Holder
- Pharmacopoeia Commission
Correct Answer: Institutional Ethics Committee / Institutional Review Board (IEC/IRB)
Q16. A marketing authorization application should include which of the following?
- Only pricing and reimbursement plans
- Only marketing materials
- Quality (CMC), nonclinical and clinical data
- Only manufacturing facility layouts
Correct Answer: Quality (CMC), nonclinical and clinical data
Q17. One major advantage of eCTD over paper submissions is:
- It removes the need for any supporting data
- It standardizes dossier structure and supports lifecycle submissions and tracking
- It guarantees faster approval times in all regions
- It replaces the need for stability studies
Correct Answer: It standardizes dossier structure and supports lifecycle submissions and tracking
Q18. A regulatory obligation in pharmacovigilance for marketing authorization holders is to:
- Perform all clinical trials internally
- Report serious adverse events and periodic safety reports within specified timelines
- Certify Good Manufacturing Practices for competitors
- Approve labeling changes without agency notification
Correct Answer: Report serious adverse events and periodic safety reports within specified timelines
Q19. GMP stands for:
- General Medical Procedures
- Good Manufacturing Practice
- Global Market Policy
- Guaranteed Marketing Permission
Correct Answer: Good Manufacturing Practice
Q20. Regulatory intelligence refers to:
- Internal audit findings only
- Monitoring, analyzing and applying regulatory requirements and trends to strategy
- Only clinical data interpretation
- Marketing performance analysis
Correct Answer: Monitoring, analyzing and applying regulatory requirements and trends to strategy
Q21. Why are stability studies performed?
- To determine marketing strategy
- To establish product shelf life and storage conditions
- To test patient acceptability of packaging
- To validate manufacturing equipment
Correct Answer: To establish product shelf life and storage conditions
Q22. Labeling regulations primarily ensure that:
- Products are stored in the same warehouse
- Accurate and sufficient information is provided for safe and effective use
- All packaging is aesthetically pleasing
- Pricing details are printed on the label
Correct Answer: Accurate and sufficient information is provided for safe and effective use
Q23. Orphan drug designation is granted for medicines that:
- Treat common conditions only
- Treat rare diseases and may receive incentives
- Are manufactured only in one country
- Are available over the counter
Correct Answer: Treat rare diseases and may receive incentives
Q24. The primary goal of bioequivalence studies for generics is to:
- Show improved efficacy over the reference product
- Demonstrate similar bioavailability to the reference listed product
- Compare manufacturing costs
- Assess long-term safety in thousands of patients
Correct Answer: Demonstrate similar bioavailability to the reference listed product
Q25. Which authority issues a Certificate of Pharmaceutical Product (CPP)?
- Local hospital pharmacy
- Competent national regulatory authority
- World Health Organization only
- Pharmaceutical sales department
Correct Answer: Competent national regulatory authority
Q26. Which CTD module is region-specific and contains national administrative information?
- Module 1
- Module 2
- Module 3
- Module 5
Correct Answer: Module 1
Q27. During regulatory inspections, the regulatory affairs team typically:
- Leads the scientific lab testing
- Liaises with inspectors, provides documentation and manages responses to findings
- Handles raw material procurement only
- Prepares commercial launch events
Correct Answer: Liaises with inspectors, provides documentation and manages responses to findings
Q28. A stability‑indicating analytical method is designed to:
- Measure only the active ingredient without detecting degradants
- Detect and quantify degradation products and the active substance accurately
- Only determine dissolution rate at a single time point
- Measure color and odor changes only
Correct Answer: Detect and quantify degradation products and the active substance accurately
Q29. Priority or expedited review pathways are typically granted for products that:
- Target trivial cosmetic conditions
- Address unmet medical needs or show major therapeutic advantage
- Have the highest manufacturing margins
- Are intended solely for veterinary use
Correct Answer: Address unmet medical needs or show major therapeutic advantage
Q30. Which CTD module contains quality (chemical, manufacturing and control) information?
- Module 2
- Module 3
- Module 4
- Module 5
Correct Answer: Module 3
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