Regulatory Agencies – CDSCO, USFDA, EMA, TGA, MHRA MCQs With Answer

Regulatory Agencies – CDSCO, USFDA, EMA, TGA, MHRA MCQs With Answer

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Introduction: This quiz collection on Regulatory Agencies — CDSCO, USFDA, EMA, TGA, and MHRA — is designed for M.Pharm students studying MIP 104T (Intellectual Property Rights) who need a practical understanding of global regulatory frameworks. The questions focus on the roles, application pathways, regulatory exclusivities, pharmacovigilance, clinical trial permissions, and agency-specific procedures that influence drug development, approval and market protection. These MCQs blend regulatory science with IPR implications (e.g., data exclusivity vs patent protection), helping students connect legal protections with real-world approval strategies. Practice with these scenarios to strengthen your exam readiness and regulatory decision-making skills.

Q1. What does CDSCO stand for?

  • Central Drug Safety and Control Office
  • Central Drugs Standard Control Organization
  • Countrywide Drug Supervisory and Control Organization
  • Central Directorate of Scientific Control of Organics

Correct Answer: Central Drugs Standard Control Organization

Q2. Who is the statutory head of CDSCO responsible for regulatory approvals in India?

  • Chairperson, Drug Advisory Board
  • Director General of Health Services
  • Drug Controller General of India (DCGI)
  • Secretary, Ministry of Health and Family Welfare

Correct Answer: Drug Controller General of India (DCGI)

Q3. Which USFDA center is primarily responsible for regulation of biological products such as vaccines and blood products?

  • Center for Drug Evaluation and Research (CDER)
  • Center for Devices and Radiological Health (CDRH)
  • Center for Biologics Evaluation and Research (CBER)
  • Office of Generic Drugs (OGD)

Correct Answer: Center for Biologics Evaluation and Research (CBER)

Q4. Which regulatory submission is used in the United States for approval of innovator small-molecule drugs?

  • Abbreviated New Drug Application (ANDA)
  • Investigational New Drug application (IND)
  • New Drug Application (NDA)
  • Biologics License Application (BLA)

Correct Answer: New Drug Application (NDA)

Q5. The US 505(b)(2) pathway is best described as which of the following?

  • A submission solely for generic copies with identical active ingredients
  • A full dossier requiring all preclinical and clinical studies from scratch
  • A hybrid pathway that relies in part on existing published data or another sponsor’s findings
  • A special application reserved only for vaccines

Correct Answer: A hybrid pathway that relies in part on existing published data or another sponsor’s findings

Q6. What does eCTD stand for in regulatory submissions?

  • electronic Clinical Trial Database
  • electronic Common Technical Document
  • enhanced Clinical and Technical Dossier
  • electronic Commission for Technical Documentation

Correct Answer: electronic Common Technical Document

Q7. Which EMA procedure results in a single marketing authorization valid across all EU member states?

  • National procedure
  • Decentralized procedure
  • Mutual recognition procedure
  • Centralized procedure

Correct Answer: Centralized procedure

Q8. How many years of market exclusivity does the US Orphan Drug designation provide upon approval?

  • 10 years
  • 5 years
  • 7 years
  • 3 years

Correct Answer: 7 years

Q9. In the European regulatory system, what is the Pediatric Investigation Plan (PIP)?

  • A marketing authorization for pediatric-only medicines
  • A regulatory requirement describing studies and measures to ensure safe and effective medicine use in children
  • A post-marketing safety monitoring program only for vaccines
  • A pricing and reimbursement submission for pediatric drugs

Correct Answer: A regulatory requirement describing studies and measures to ensure safe and effective medicine use in children

Q10. Which initiative by the EMA is intended to enhance support and accelerate development of priority medicines for unmet medical needs?

  • Fast Track Designation
  • PRIME (PRIority MEdicines)
  • Breakthrough Therapy
  • Priority Review Voucher

Correct Answer: PRIME (PRIority MEdicines)

Q11. The MHRA is the national regulatory authority for medicines and medical devices in which country?

  • Canada
  • United Kingdom
  • South Africa
  • New Zealand

Correct Answer: United Kingdom

Q12. After Brexit, which statement best describes the MHRA’s role relative to the EMA?

  • MHRA became a regional office of the EMA
  • MHRA stopped regulating medicines and delegated authority to EMA
  • MHRA functions as the UK’s independent medicines regulator, separate from EMA
  • MHRA only advises manufacturers but does not grant marketing authorizations

Correct Answer: MHRA functions as the UK’s independent medicines regulator, separate from EMA

Q13. What does TGA stand for in the context of pharmaceutical regulation?

  • Therapeutic Goods Administration (Australia)
  • Transnational Generic Authority
  • Therapeutics and Governance Agency
  • Toxicology and Genomics Authority

Correct Answer: Therapeutic Goods Administration (Australia)

Q14. Which submission must be filed in the United States before beginning human clinical trials?

  • New Drug Application (NDA)
  • Investigational New Drug application (IND)
  • Abbreviated New Drug Application (ANDA)
  • Biologics License Application (BLA)

Correct Answer: Investigational New Drug application (IND)

Q15. In the Common Technical Document (CTD) format, which Module is considered region-specific and varies between regulators?

  • Module 2 — Summaries
  • Module 1 — Regional administrative information
  • Module 3 — Quality (CMC)
  • Module 5 — Clinical study reports

Correct Answer: Module 1 — Regional administrative information

Q16. Which of the following best describes regulatory data exclusivity?

  • Patent protection granted by the patent office
  • A market protection period during which regulatory agencies will not accept generic applications relying on originator data
  • A requirement to publish clinical data publicly after approval
  • A manufacturing exclusivity preventing other firms from producing the active moiety

Correct Answer: A market protection period during which regulatory agencies will not accept generic applications relying on originator data

Q17. The approval pathway for biosimilars primarily relies on which scientific approach?

  • Complete replication of innovator clinical trials at full scale
  • Comparability exercises demonstrating similarity in quality, safety and efficacy
  • Only in vitro testing without clinical data
  • Patent expiry alone without regulatory review

Correct Answer: Comparability exercises demonstrating similarity in quality, safety and efficacy

Q18. Good Manufacturing Practice (GMP) inspections by regulators are primarily intended to evaluate which of the following?

  • The commercial pricing strategy for a drug
  • The validity of the company’s patents
  • The quality systems, facility conditions, and manufacturing controls to ensure product quality
  • The efficacy of the drug in phase III trials

Correct Answer: The quality systems, facility conditions, and manufacturing controls to ensure product quality

Q19. What is an RMP (Risk Management Plan) in the context of EMA requirements?

  • A plan outlining pricing and reimbursement strategies for a new medicine
  • A post-authorization document describing identified and potential safety risks and measures to minimize them
  • A manufacturing batch release protocol
  • A marketing and promotional plan

Correct Answer: A post-authorization document describing identified and potential safety risks and measures to minimize them

Q20. Which USFDA pathway allows earlier approval of drugs for serious conditions based on surrogate or intermediate clinical endpoints reasonably likely to predict clinical benefit?

  • Priority Review
  • Accelerated Approval
  • Fast Track
  • Breakthrough Therapy designation

Correct Answer: Accelerated Approval

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