Introduction
Understanding major global regulatory authorities and their roles is essential for B. Pharm students. Regulatory bodies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Central Drugs Standard Control Organization (CDSCO), World Health Organization (WHO) and International Council for Harmonisation (ICH) set standards for clinical trials, GMP, GLP, pharmacovigilance, marketing authorization, dossier submission (CTD), and post-marketing surveillance. This overview highlights how agencies evaluate safety, efficacy, quality, biosimilars, orphan drug designation, and inspection processes. Familiarity with global frameworks—ICH guidelines, PIC/S, and regional approval pathways—prepares pharmacy graduates for regulatory affairs, drug development, quality assurance, and pharmacovigilance careers. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which agency is primarily responsible for premarket review and approval of pharmaceuticals in the United States?
- European Medicines Agency (EMA)
- Central Drugs Standard Control Organization (CDSCO)
- Food and Drug Administration (FDA)
- World Health Organization (WHO)
Correct Answer: Food and Drug Administration (FDA)
Q2. Which global organization issues technical guidance and prequalification for medicines used in public health programs worldwide?
- ICH (International Council for Harmonisation)
- WHO (World Health Organization)
- PIC/S (Pharmaceutical Inspection Co-operation Scheme)
- EMA (European Medicines Agency)
Correct Answer: WHO (World Health Organization)
Q3. The EMA centralized procedure is mandatory for which category of products?
- Generic small-molecule drugs only
- All over-the-counter medicines
- Biotechnology-derived medicines, orphan drugs, and certain high-tech therapies
- Medical devices
Correct Answer: Biotechnology-derived medicines, orphan drugs, and certain high-tech therapies
Q4. Which Indian regulatory body is the national authority for approval of clinical trials and new drugs in India?
- NMPA (National Medical Products Administration)
- CDSCO (Central Drugs Standard Control Organization)
- ANVISA (Agência Nacional de Vigilância Sanitária)
- MHRA (Medicines and Healthcare products Regulatory Agency)
Correct Answer: CDSCO (Central Drugs Standard Control Organization)
Q5. Which harmonization body develops guidelines such as Q1 (stability) and E6 (GCP) to align technical requirements across regions?
- WHO
- ICH (International Council for Harmonisation)
- FDA
- PIC/S
Correct Answer: ICH (International Council for Harmonisation)
Q6. What does CTD stand for and which purpose does it serve in regulatory submissions?
- Clinical Trial Documentation; used only for investigator brochures
- Common Technical Document; standardized dossier format for marketing authorization applications
- Country Technical Dossier; region-specific labeling documents
- Clinical Therapeutic Data; used for post-marketing surveillance reports
Correct Answer: Common Technical Document; standardized dossier format for marketing authorization applications
Q7. Which agency is known for issuing Fast Track, Breakthrough Therapy, and Priority Review designations?
- EMA
- FDA
- PMDA (Japan)
- TGA (Australia)
Correct Answer: FDA
Q8. PIC/S primarily focuses on which aspect of regulatory systems across participating authorities?
- Clinical trial efficacy endpoints
- Harmonisation of inspection procedures and GMP standards
- Pricing and reimbursement policies
- Trademark and patent coordination
Correct Answer: Harmonisation of inspection procedures and GMP standards
Q9. Which regulatory document outlines requirements for non-clinical safety studies before human trials?
- ICH M4 CTD Module 2
- ICH S-series guidelines (safety)
- GCP E6 guideline
- EMA Pharmacovigilance Guideline
Correct Answer: ICH S-series guidelines (safety)
Q10. In the EU, what is the main post-authorization risk management document required for new medicines?
- IND (Investigational New Drug)
- RMP (Risk Management Plan)
- NDA (New Drug Application)
- PMS (Product Marketing Summary)
Correct Answer: RMP (Risk Management Plan)
Q11. Which authority performs regulatory oversight and approval of pharmaceuticals in Japan?
- FDA
- PMDA (Pharmaceuticals and Medical Devices Agency)
- EMA
- ANVISA
Correct Answer: PMDA (Pharmaceuticals and Medical Devices Agency)
Q12. Which guideline category from ICH covers quality aspects such as impurity thresholds and analytical validation?
- Q-series
- E-series
- M-series
- S-series
Correct Answer: Q-series
Q13. What is the primary purpose of WHO Prequalification of Medicines Programme?
- Grant marketing authorization in the EU
- Assess quality, safety and efficacy for procurement by UN agencies and low-income countries
- Replace national regulatory approval systems
- Provide pricing guidance for pharmaceutical products
Correct Answer: Assess quality, safety and efficacy for procurement by UN agencies and low-income countries
Q14. Which regulatory pathway allows a single centralized marketing authorization valid across all EU member states?
- Decentralized Procedure
- Mutual Recognition Procedure
- Centralized Procedure
- National Procedure
Correct Answer: Centralized Procedure
Q15. Which authority is responsible for regulating medicines in China?
- NMPA (National Medical Products Administration)
- CDSCO
- ANVISA
- MHRA
Correct Answer: NMPA (National Medical Products Administration)
Q16. Which of the following is a key responsibility of a national regulatory authority in pharmacovigilance?
- Manufacturing of active pharmaceutical ingredients
- Collecting and analyzing adverse drug reaction reports and enforcing safety actions
- Designing clinical trial protocols for sponsors
- Setting retail pharmacy prices
Correct Answer: Collecting and analyzing adverse drug reaction reports and enforcing safety actions
Q17. The dossier section that summarizes nonclinical and clinical data for a marketing application is found in which CTD module?
- Module 1 (Administrative information)
- Module 2 (Summaries of quality, nonclinical, and clinical)
- Module 3 (Quality)
- Module 4 (Nonclinical study reports)
Correct Answer: Module 2 (Summaries of quality, nonclinical, and clinical)
Q18. Which regulatory authority introduced the Conditional Marketing Authorization pathway in the EU to accelerate access to medicines?
- FDA
- EMA
- PMDA
- CDSCO
Correct Answer: EMA
Q19. Which international standard describes Good Clinical Practice (GCP) guidelines widely adopted by regulators?
- ICH E6
- ICH Q7
- WHO GMP Annex
- PIC/S PE 009
Correct Answer: ICH E6
Q20. Which agency is the primary regulator for medicines and medical devices in the United Kingdom after Brexit?
- EMA
- MHRA (Medicines and Healthcare products Regulatory Agency)
- TGA
- Health Canada
Correct Answer: MHRA (Medicines and Healthcare products Regulatory Agency)
Q21. What is the main role of an Investigational New Drug (IND) application in the US regulatory process?
- To request marketing authorization for a generic drug
- To obtain permission to start clinical trials in humans
- To register a manufacturing facility with FDA
- To apply for orphan drug designation
Correct Answer: To obtain permission to start clinical trials in humans
Q22. Which of the following agencies enforces Good Manufacturing Practice (GMP) through inspections and regulatory actions internationally via cooperation schemes?
- ICH only
- PIC/S and national regulators
- WHO only
- FDA exclusively
Correct Answer: PIC/S and national regulators
Q23. In regulatory submissions, what is the purpose of a PBRER (Periodic Benefit-Risk Evaluation Report)?
- To document preclinical pharmacology data
- To periodically summarize accumulated safety data and benefit-risk profile post-authorization
- To replace clinical study reports
- To submit manufacturing batch release data
Correct Answer: To periodically summarize accumulated safety data and benefit-risk profile post-authorization
Q24. Which regulatory concept ensures that biosimilars demonstrate no clinically meaningful differences from the reference biologic in safety and efficacy?
- Bioequivalence
- Interchangeability and comparability for biosimilars
- Good Laboratory Practice (GLP)
- Conditional approval
Correct Answer: Interchangeability and comparability for biosimilars
Q25. Which agency is responsible for health product regulation in Canada?
- FDA
- Health Canada
- EMA
- PMDA
Correct Answer: Health Canada
Q26. Which regulatory dossier element contains analytical methods, manufacturing process, and controls for a drug product?
- Nonclinical study reports
- Module 3 (Quality)
- Clinical study reports
- Module 1 administrative forms
Correct Answer: Module 3 (Quality)
Q27. What is an orphan drug designation intended to encourage?
- Faster generic entry for common drugs
- Development of treatments for rare diseases through incentives
- Global harmonization of GMP inspections
- Mandatory biosimilar substitution
Correct Answer: Development of treatments for rare diseases through incentives
Q28. Which regulatory authority is ANVISA and which country does it serve?
- ANVISA is Brazil’s regulatory agency
- ANVISA is Australia’s regulatory agency
- ANVISA is India’s regulatory agency
- ANVISA is South Africa’s regulatory agency
Correct Answer: ANVISA is Brazil’s regulatory agency
Q29. What is the typical regulatory timeframe concept referring to expedited assessment by EMA or FDA for medicines addressing unmet medical needs?
- Priority Review / Accelerated Assessment
- Standard National Procedure
- Mutual Recognition Timeframe
- Pharmacovigilance Window
Correct Answer: Priority Review / Accelerated Assessment
Q30. Which document is essential for global regulatory harmonization by providing common formats and technical information for product approval?
- Common Technical Document (CTD)
- Investigator’s Brochure only
- Clinical Trial Protocol Template exclusively
- National Advertising Guidelines
Correct Answer: Common Technical Document (CTD)
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