Global Harmonization Task Force (GHTF) guidance MCQs With Answer

Introduction:
This blog presents a focused set of multiple-choice questions on the Global Harmonization Task Force (GHTF) guidance specifically tailored for M.Pharm students studying Good Regulatory Practices. The questions explore GHTF’s history, objectives, organizational role, key guidance documents, device classification principles, pre‑market and post‑market requirements, clinical evaluation expectations, and the transition to the International Medical Device Regulators Forum (IMDRF). Each item is designed to deepen your understanding of how GHTF influenced global medical device regulatory convergence, conformity assessment approaches, and the practical use of guidance documents by manufacturers and regulators. Use these MCQs to test and reinforce your regulatory knowledge for academics and practice.

Q1. What was the primary focus of the Global Harmonization Task Force (GHTF)?

• Harmonization of pharmaceutical clinical trial designs
• Harmonization of medical device regulatory practices
• Global food safety regulation alignment
• Creation of binding international treaties

Correct Answer: Harmonization of medical device regulatory practices

Q2. In which year was the GHTF established?

• 1990
• 1992
• 2000
• 2011

Correct Answer: 1992

Q3. How many founding members initially collaborated to form the GHTF?

• Three
• Five
• Seven
• Ten

Correct Answer: Five

Q4. Which international group was formed to continue and expand the work of the GHTF?

• World Health Organization (WHO)
• International Council for Harmonisation (ICH)
• International Medical Device Regulators Forum (IMDRF)
• International Organization for Standardization (ISO)

Correct Answer: International Medical Device Regulators Forum (IMDRF)

Q5. What is the legal status of GHTF guidance documents?

• They are binding international law
• They are non-binding guidance documents
• They are mandatory regulations for all members
• They are national statutes that must be adopted unchanged

Correct Answer: They are non-binding guidance documents

Q6. Which GHTF document provides a high-level framework for device safety and performance principles?

• Guidance on Pharmaceutical Good Manufacturing Practice
• Essential Principles of Safety and Performance of Medical Devices
• International Food Safety Principles
• Guidance on Veterinary Product Standards

Correct Answer: Essential Principles of Safety and Performance of Medical Devices

Q7. Which stages of the device lifecycle did GHTF guidance address?

• Only pre-market review
• Only post-market surveillance
• Both pre-market and post-market activities
• Only manufacturing quality control

Correct Answer: Both pre-market and post-market activities

Q8. Which of the following is NOT typically considered a core stakeholder group in the GHTF process?

• National regulatory authorities
• Industry and manufacturers
• Notified bodies and conformity assessment organizations
• Veterinary clinics and animal breeders

Correct Answer: Veterinary clinics and animal breeders

Q9. Which international quality management standard did GHTF guidance encourage alignment with for medical devices?

• ISO 9001
• ISO 13485
• Good Laboratory Practice (GLP)
• Good Manufacturing Practice (GMP) for pharmaceuticals

Correct Answer: ISO 13485

Q10. According to GHTF guidance, which sources can be used to support clinical evaluation of a medical device?

• Clinical investigations, relevant scientific literature, and post-market data
• Only randomized controlled trials conducted by the manufacturer
• Marketing claims and promotional materials
• Animal studies exclusively

Correct Answer: Clinical investigations, relevant scientific literature, and post-market data

Q11. Which of the following was NOT an objective of the GHTF?

• Promote international convergence of regulatory practices
• Reduce regulatory duplication and burdens
• Develop legally binding international medical device laws
• Facilitate timely access to safe and effective devices

Correct Answer: Develop legally binding international medical device laws

Q12. One intended outcome of adopting GHTF guidance among regulators was to enable what practice?

• Mutual acceptance of regulatory information and reviews
• Complete elimination of all national regulatory reviews
• Exclusive reliance on device manufacturer self-certification without assessment
• Universal tariffs on medical device trade

Correct Answer: Mutual acceptance of regulatory information and reviews

Q13. Which topic was explicitly covered by GHTF study group guidance?

• Principles of medical device classification
• Approval processes for new chemical entities
• Crop protection pesticide registration
• Pharmacovigilance for vaccines

Correct Answer: Principles of medical device classification

Q14. GHTF guidance on post-market surveillance emphasized the importance of which system?

• Routine randomized clinical trials for all marketed devices
• A structured vigilance and adverse event reporting system
• Elimination of adverse event collection after approval
• Marketing-based performance monitoring only

Correct Answer: A structured vigilance and adverse event reporting system

Q15. For conformity assessment, GHTF guidance generally recommended reliance on which combination?

• Inspection of retail stores and marketing audits
• Quality management systems (e.g., ISO 13485) plus technical documentation review
• Only self-declaration without documentation
• Clinical trial replication in each country before market

Correct Answer: Quality management systems (e.g., ISO 13485) plus technical documentation review

Q16. Why did GHTF emphasize common terminology and definitions across jurisdictions?

• To increase product prices globally
• To improve regulatory harmonization and mutual understanding
• To restrict innovation in device design
• To replace national laws with a single global law

Correct Answer: To improve regulatory harmonization and mutual understanding

Q17. The GHTF “Essential Principles” framework applies to which categories of devices?

• Only high-risk (Class III) devices
• Only sterile devices
• All classes and types of medical devices
• Only in vitro diagnostic devices

Correct Answer: All classes and types of medical devices

Q18. Which of the following is an example title of a GHTF guidance related to clinical demonstration?

• Clinical Evaluation: A Guide for Manufacturers
• Guidance on Veterinary Clinical Trials
• Pharmaceutical Bioequivalence Manual
• Food Additive Safety Evaluation

Correct Answer: Clinical Evaluation: A Guide for Manufacturers

Q19. What is a commonly noted limitation of GHTF guidances when applied worldwide?

• They were universally binding and rigid
• Their non-binding nature meant variable national adoption
• They mandated a single global regulatory agency
• They addressed only pharmaceutical products

Correct Answer: Their non-binding nature meant variable national adoption

Q20. How should manufacturers practically use GHTF guidance when preparing for regulatory submissions?

• As a rigid legal text that must be followed word-for-word without adaptation
• As a framework to develop regulatory strategies and prepare technical documentation adapted to local requirements
• As marketing material to replace clinical evidence
• As an obligation to stop all post-market surveillance

Correct Answer: As a framework to develop regulatory strategies and prepare technical documentation adapted to local requirements

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