Introduction: Regulatory requirements for the drug approval process cover the scientific, legal, and procedural steps needed to bring safe and effective medicines to market. For B. Pharm students, understanding key concepts—preclinical studies, IND submissions, clinical trial phases, NDA/ANDA filings, CTD/eCTD dossiers, GMP, GLP, GCP, bioequivalence, pharmacovigilance, and regulatory authorities (FDA, EMA, CDSCO)—is essential. This topic emphasizes dossier preparation, quality (CMC) data, safety monitoring, expedited pathways, and post-marketing obligations. Mastery of these areas helps future pharmacists contribute to drug development, compliance, and patient safety. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of an Investigational New Drug (IND) application?
- To request marketing approval for a generic drug
- To obtain permission to begin human clinical trials
- To register a manufactured batch for sale
- To report adverse events after marketing
Correct Answer: To obtain permission to begin human clinical trials
Q2. Which module of the Common Technical Document (CTD) contains clinical study reports and investigator information?
- Module 1
- Module 2
- Module 3
- Module 5
Correct Answer: Module 5
Q3. Good Manufacturing Practice (GMP) primarily addresses which aspect of drug development?
- Clinical trial design
- Animal toxicology studies
- Quality of production and batch consistency
- Marketing and labeling strategies
Correct Answer: Quality of production and batch consistency
Q4. Which guideline defines ethical principles and standards for the conduct of clinical trials?
- ICH Q8
- ICH E6 (GCP)
- ICH M4
- ICH Q3A
Correct Answer: ICH E6 (GCP)
Q5. For bioequivalence studies of oral immediate-release generics, the accepted 90% confidence interval for AUC and Cmax is commonly:
- 70–130%
- 80–125%
- 90–110%
- 50–150%
Correct Answer: 80–125%
Q6. The New Drug Application (NDA) is submitted to which authority in the United States?
- EMA
- CDSCO
- FDA
- WHO
Correct Answer: FDA
Q7. Which regulatory pathway is intended to facilitate earlier approval for drugs addressing unmet medical needs with substantial evidence of benefit?
- ANDA
- Priority review / Breakthrough therapy pathways
- Standard marketing authorization
- Generic registration
Correct Answer: Priority review / Breakthrough therapy pathways
Q8. What does ANDA stand for and what is its purpose?
- Active New Drug Application — for innovative drugs
- Abbreviated New Drug Application — for approval of generics without new clinical trials
- Alternative New Drug Assessment — for biologics
- Authorized New Drug Application — for orphan drugs
Correct Answer: Abbreviated New Drug Application — for approval of generics without new clinical trials
Q9. Which document provides an annual safety evaluation of a drug under clinical development?
- PSUR (Period Safety Update Report)
- DSUR (Development Safety Update Report)
- NDA
- GMP certificate
Correct Answer: DSUR (Development Safety Update Report)
Q10. Which component of a regulatory dossier covers chemistry, manufacturing, and controls?
- Clinical overview
- Nonclinical pharmacology
- Module 3 (CMC)
- Labeling and packaging
Correct Answer: Module 3 (CMC)
Q11. What is the role of pharmacovigilance after a drug is marketed?
- Only marketing the product
- Monitoring, detecting, and preventing adverse drug reactions
- Conducting basic research on new compounds
- Manufacturing the drug
Correct Answer: Monitoring, detecting, and preventing adverse drug reactions
Q12. Which of the following is a key requirement for stability studies in a submission dossier?
- Short-term single temperature testing only
- Long-term and accelerated stability data under ICH conditions
- Only in-use stability testing
- No stability data required for an ANDA
Correct Answer: Long-term and accelerated stability data under ICH conditions
Q13. What does eCTD stand for?
- electronic Common Technical Document
- extended Clinical Trial Dossier
- elective Chemical Testing Data
- enhanced Clinical Trial Declaration
Correct Answer: electronic Common Technical Document
Q14. Which study phase primarily evaluates safety and dosage in a small number of healthy volunteers?
- Phase IV
- Phase III
- Phase I
- Phase II
Correct Answer: Phase I
Q15. Orphan drug designation is intended for drugs that treat:
- Common chronic diseases
- Rare diseases with small patient populations
- Only pediatric conditions
- Only veterinary uses
Correct Answer: Rare diseases with small patient populations
Q16. Which regulatory document outlines the quality target product profile (QTPP) and design space?
- ICH Q8 (Pharmaceutical Development)
- ICH E2A
- ICH Q1A
- ICH M4
Correct Answer: ICH Q8 (Pharmaceutical Development)
Q17. What is a Risk Management Plan (RMP) primarily used for?
- Describing manufacturing steps
- Identifying and minimizing safety risks during and after approval
- Providing pricing strategy
- Defining clinical trial endpoints
Correct Answer: Identifying and minimizing safety risks during and after approval
Q18. Which regulatory authority issues Marketing Authorization in the European Union?
- FDA
- EMA (European Medicines Agency)
- MHRA only
- CDSCO
Correct Answer: EMA (European Medicines Agency)
Q19. What is the primary objective of GLP (Good Laboratory Practice)?
- To control clinical trial conduct
- To ensure quality and integrity of nonclinical laboratory studies
- To regulate manufacturing sites
- To manage marketing activities
Correct Answer: To ensure quality and integrity of nonclinical laboratory studies
Q20. Which is typically required for a biosimilar approval but differs from small-molecule generics?
- No clinical data needed
- Extensive comparability studies including clinical, analytical, and immunogenicity data
- Only a simple bioequivalence study
- Patent waiver automatically granted
Correct Answer: Extensive comparability studies including clinical, analytical, and immunogenicity data
Q21. Which agency is responsible for drug regulation in India?
- EMA
- FDA
- CDSCO
- MHRA
Correct Answer: CDSCO
Q22. What is the main objective of clinical trial registration (e.g., ClinicalTrials.gov)?
- To obtain marketing approval
- To promote transparency and public access to trial information
- To replace ethics committee approval
- To publish final results without peer review
Correct Answer: To promote transparency and public access to trial information
Q23. Accelerated approval often relies on what type of endpoints?
- Traditional long-term clinical benefit endpoints only
- Surrogate or intermediate clinical endpoints reasonably likely to predict benefit
- Only safety endpoints
- Manufacturing yield endpoints
Correct Answer: Surrogate or intermediate clinical endpoints reasonably likely to predict benefit
Q24. What is the typical review goal time for a priority review by the FDA?
- 12 months
- 10 months
- 6 months
- 24 months
Correct Answer: 6 months
Q25. Which report summarizes all adverse reactions and provides a periodic safety update after marketing?
- DSUR
- PSUR / PBRER
- Investigational Brochure
- eCTD technical validation report
Correct Answer: PSUR / PBRER
Q26. In regulatory terminology, what does CMC stand for?
- Clinical, Marketing, and Cost
- Chemistry, Manufacturing, and Controls
- Comparative Medical Conditions
- Compliance, Monitoring, and Certification
Correct Answer: Chemistry, Manufacturing, and Controls
Q27. What is an Investigational Medicinal Product Dossier (IMPD) used for?
- Marketing authorization of generics
- Support of clinical trial applications in the EU containing quality and safety information of the investigational product
- Only for post-marketing surveillance
- To register biosimilars in the US
Correct Answer: Support of clinical trial applications in the EU containing quality and safety information of the investigational product
Q28. Which procedure requires demonstration of therapeutic equivalence and patent status before generic approval in some jurisdictions?
- ANDA with patent linkage
- New chemical entity NDA
- Orphan drug application
- GCP certification
Correct Answer: ANDA with patent linkage
Q29. What is the main purpose of a clinical study protocol?
- To market the trial drug
- To provide a detailed plan describing objectives, methodology, statistical considerations, and organization of a clinical trial
- To replace informed consent
- To manufacture clinical supplies
Correct Answer: To provide a detailed plan describing objectives, methodology, statistical considerations, and organization of a clinical trial
Q30. What does ICH stand for and why is it important?
- International Council for Harmonisation — it develops global guidelines to harmonize technical requirements for pharmaceuticals
- Institute of Clinical Health — it funds trials worldwide
- International Compliance Hub — it enforces penalties
- Independent Chemical Harmonization — it standardizes chemical names
Correct Answer: International Council for Harmonisation — it develops global guidelines to harmonize technical requirements for pharmaceuticals
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