Regulatory affairs in pharmaceuticals covers laws, guidelines, and processes that ensure drugs are safe, effective and of consistent quality. For B. Pharm students, mastering regulatory frameworks—national authorities (FDA, EMA, CDSCO), ICH guidance, CTD/eCTD dossiers, GMP, GCP, GLP, pharmacovigilance, clinical trial approvals, and post-marketing surveillance—is vital for career readiness. This introduction outlines the scope including submission pathways (IND, NDA, ANDA), dossier content, stability and bioequivalence requirements, labeling, and lifecycle management. Learn how regulatory professionals prepare submissions, manage compliance, and interact with authorities to achieve market access. Keywords: regulatory affairs, drug approval, CTD, GMP, pharmacovigilance, IND, NDA, ANDA, bioequivalence. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary role of regulatory affairs in the pharmaceutical industry?
- Ensuring compliance with laws and guidelines for drug development and marketing
- Designing chemical synthesis routes for APIs
- Performing routine QC laboratory tests only
- Managing hospital pharmacy inventories
Correct Answer: Ensuring compliance with laws and guidelines for drug development and marketing
Q2. Which of the following lists major regulatory agencies?
- US FDA, EMA and CDSCO
- WHO, UNICEF and FAO
- ISO, IEC and ASTM
- CDC, NIH and OSHA
Correct Answer: US FDA, EMA and CDSCO
Q3. CTD in regulatory submissions stands for which term?
- Common Technical Document
- Clinical Trial Dossier
- Centralized Testing Directive
- Comprehensive Therapeutic Data
Correct Answer: Common Technical Document
Q4. What does eCTD refer to in modern regulatory practice?
- Electronic Common Technical Document for structured submissions
- Enhanced Clinical Trial Design
- Extended Chemical Testing Directive
- Emergency Clinical Trial Documentation
Correct Answer: Electronic Common Technical Document for structured submissions
Q5. An IND application is submitted to obtain permission to:
- Start clinical trials in humans
- Launch a generic product without trials
- Request a patent extension
- Export controlled substances
Correct Answer: Start clinical trials in humans
Q6. The purpose of an NDA is to:
- Seek marketing approval for a new drug
- Apply for a clinical trial waiver
- Register a medical device only
- Request orphan designation
Correct Answer: Seek marketing approval for a new drug
Q7. ANDA stands for:
- Abbreviated New Drug Application
- Authorized New Drug Approval
- Analytical New Drug Assessment
- Advanced New Drug Architecture
Correct Answer: Abbreviated New Drug Application
Q8. Why are bioequivalence studies required for generic drug approval?
- To demonstrate similar bioavailability to the reference listed drug
- To test manufacturing equipment suitability
- To evaluate environmental impact of production
- To validate packaging aesthetics
Correct Answer: To demonstrate similar bioavailability to the reference listed drug
Q9. GCP stands for which regulatory principle?
- Good Clinical Practice
- General Compliance Procedure
- Good Chemical Production
- Global Clinical Policy
Correct Answer: Good Clinical Practice
Q10. GLP is primarily concerned with:
- Quality and integrity of non-clinical laboratory studies
- Marketing practices for pharmaceuticals
- Clinical trial recruitment
- Pharmacovigilance reporting timelines
Correct Answer: Quality and integrity of non-clinical laboratory studies
Q11. GMP ensures:
- Consistent manufacture of products meeting quality standards
- Faster clinical trial approvals
- Tax exemptions for pharmaceutical companies
- Marketing strategies for new drugs
Correct Answer: Consistent manufacture of products meeting quality standards
Q12. Pharmacovigilance focuses on:
- Detection, assessment and prevention of adverse drug reactions
- Only preclinical toxicology testing
- Sales performance of pharmaceutical reps
- Formulation optimization for solubility
Correct Answer: Detection, assessment and prevention of adverse drug reactions
Q13. How many modules are there in the ICH CTD structure?
- 5 modules
- 3 modules
- 7 modules
- 10 modules
Correct Answer: 5 modules
Q14. Stability studies in a regulatory dossier determine:
- Shelf life and storage conditions of the drug product
- Optimal marketing regions for the product
- Clinical trial sample size only
- Patentability of the molecule
Correct Answer: Shelf life and storage conditions of the drug product
Q15. A Certificate of Pharmaceutical Product (CPP) is primarily used to:
- Facilitate export and registration in other countries
- Authorize clinical trial amendments
- Replace the need for GMP inspections
- Extend patent life internationally
Correct Answer: Facilitate export and registration in other countries
Q16. Orphan drug designation typically provides which benefit?
- Market exclusivity and development incentives
- Automatic approval without trials
- Higher allowed impurity limits
- Exemption from pharmacovigilance
Correct Answer: Market exclusivity and development incentives
Q17. Terms like Fast Track, Breakthrough Therapy, and Priority Review describe:
- Accelerated regulatory pathways to speed development and review
- New formulation techniques
- Manufacturing contamination classes
- Pharmacopoeial monograph categories
Correct Answer: Accelerated regulatory pathways to speed development and review
Q18. Post-marketing surveillance involves:
- Monitoring safety and effectiveness of a drug after approval
- Only preclinical animal testing
- Marketing data collection for sales teams
- Batch release testing in the QC lab
Correct Answer: Monitoring safety and effectiveness of a drug after approval
Q19. Regulatory acceptance criteria for bioequivalence commonly require:
- 90% confidence interval for AUC and Cmax within 80–125%
- Mean AUC difference of less than 50%
- Single-subject equivalence only
- Absolute plasma concentration match
Correct Answer: 90% confidence interval for AUC and Cmax within 80–125%
Q20. A core responsibility of a regulatory affairs professional is to:
- Prepare regulatory submissions and communicate with authorities
- Operate fermentation reactors daily
- Design new chemical entities
- Manage hospital inpatient prescriptions
Correct Answer: Prepare regulatory submissions and communicate with authorities
Q21. PBRER stands for:
- Periodic Benefit-Risk Evaluation Report
- Pharmacovigilance Baseline Report
- Periodic Biological Response Evaluation Review
- Product Batch Release Evaluation Report
Correct Answer: Periodic Benefit-Risk Evaluation Report
Q22. The primary goal of Phase III clinical trials is to:
- Confirm efficacy and monitor adverse reactions in a large population
- Conduct initial human safety testing
- Provide formulation stability data only
- Assess drug metabolism in vitro
Correct Answer: Confirm efficacy and monitor adverse reactions in a large population
Q23. Good documentation practice in regulatory work emphasizes:
- Accuracy, traceability and contemporaneous record-keeping
- Removing old versions of documents permanently
- Keeping only electronic records without backups
- Using informal notes instead of official logs
Correct Answer: Accuracy, traceability and contemporaneous record-keeping
Q24. ICH stands for:
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
- International Committee for Health
- Institute of Clinical Harmonization
- International Coalition for Hospitals
Correct Answer: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Q25. The Marketing Authorization Holder (MAH) is the entity that:
- Holds responsibility for maintaining marketing authorization and product safety
- Only manufactures batches without regulatory liability
- Is responsible solely for clinical trial recruitment
- Issues pharmacopoeial monographs
Correct Answer: Holds responsibility for maintaining marketing authorization and product safety
Q26. A biosimilar development program focuses primarily on:
- Demonstrating high similarity in quality, safety and efficacy to the reference biologic
- Creating identical chemical structure to small-molecule drugs
- Replacing clinical trials entirely with in silico models
- Exempting products from GMP
Correct Answer: Demonstrating high similarity in quality, safety and efficacy to the reference biologic
Q27. Regulatory changes to an approved product are typically categorized as:
- Minor, moderate and major variations
- Chemical, biological and cultural changes
- Type A, Type B and Type Z only
- Immediate, delayed and retrospective
Correct Answer: Minor, moderate and major variations
Q28. Who issues import/export licenses and product registrations in a country?
- National regulatory authority (e.g., CDSCO, FDA)
- Local pharmacies only
- Manufacturing QA department only
- Academic institutions
Correct Answer: National regulatory authority (e.g., CDSCO, FDA)
Q29. Key advantages of eCTD submissions include:
- Standardized electronic format and improved lifecycle management
- Guaranteed faster approval regardless of content
- Elimination of the need for clinical data
- Automated GMP inspections
Correct Answer: Standardized electronic format and improved lifecycle management
Q30. A Risk Management Plan (RMP) in regulatory filings is used to:
- Identify, characterize and minimize safety risks associated with a medicine
- Outline marketing strategies for a drug
- Document manufacturing batch yields only
- Set pricing policies for different markets
Correct Answer: Identify, characterize and minimize safety risks associated with a medicine
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