ICH Guidelines – purpose, participants and harmonization process MCQs With Answer

The International Council for Harmonisation (ICH) Guidelines explain the purpose, participants and harmonization process that align global regulatory standards for pharmaceutical quality, safety and efficacy. Designed for regulatory agencies, industry experts, clinical researchers and manufacturing stakeholders, ICH creates consensus documents—like GCP (E6), CTD (M4), pharmacovigilance (E2) and quality series (Q1–Q12)—to reduce duplication, speed drug development and ensure patient safety. Key elements include Expert Working Groups, the ICH Steering Committee, stepwise adoption (drafting, consultation, adoption, implementation) and electronic submission formats (eCTD). These guidelines support global regulatory convergence and efficient review pathways. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of ICH Guidelines?

To set pricing policies for medicines
To harmonize technical requirements for pharmaceuticals internationally
To replace national regulatory laws
To certify pharmaceutical manufacturing plants

Correct Answer: To harmonize technical requirements for pharmaceuticals internationally

Q2. Which groups are official founding regulatory members of ICH?

FDA (USA), EMA (Europe), MHLW/PMDA (Japan)
WHO, UNICEF, World Bank
Pharmaceutical companies only
Centers for Disease Control and Prevention (CDC) sectors

Correct Answer: FDA (USA), EMA (Europe), MHLW/PMDA (Japan)

Q3. Which ICH category covers Quality guidelines?

E series
Q series
S series
M series

Correct Answer: Q series

Q4. What does the CTD (Common Technical Document) primarily standardize?

Clinical trial recruitment methods
Regulatory submission format for marketing applications
Patent filing procedures
Laboratory analytical methods

Correct Answer: Regulatory submission format for marketing applications

Q5. Which ICH step involves public/regulatory consultation on a draft guideline?

Step 1
Step 2
Step 3
Step 5

Correct Answer: Step 2

Q6. Which document is ICH E6 concerned with?

Good Clinical Practice (GCP)
Stability testing
Pharmacovigilance reporting format
Analytical method validation

Correct Answer: Good Clinical Practice (GCP)

Q7. Who typically composes an ICH Expert Working Group (EWG)?

Only representatives from one regulatory agency
Industry, regulatory experts and scientific specialists from multiple regions
Marketing teams from pharmaceutical companies
Patent attorneys

Correct Answer: Industry, regulatory experts and scientific specialists from multiple regions

Q8. Which ICH guideline series addresses safety topics like toxicology?

Q series
S series
E series
M series

Correct Answer: S series

Q9. In the CTD, which module contains quality (chemistry, manufacturing and controls) information?

Module 1
Module 2
Module 3
Module 5

Correct Answer: Module 3

Q10. What is the role of the ICH Steering Committee?

To implement quality control at manufacturing sites
To provide strategic direction, approve topics and oversee harmonization
To market new medicines globally
To run clinical trials for member companies

Correct Answer: To provide strategic direction, approve topics and oversee harmonization

Q11. Which ICH guideline addresses pharmacovigilance and adverse event reporting?

E2 series
Q1 series
S3 series
M1 series

Correct Answer: E2 series

Q12. What does eCTD stand for in regulatory submissions?

electronic Common Technical Document
enhanced Clinical Trial Directive
electronic Clinical Trial Data
export Certification for Therapeutic Drugs

Correct Answer: electronic Common Technical Document

Q13. Which ICH guideline focuses on Pharmaceutical Quality System (PQS)?

Correct Answer: Q10

Q14. What is a major benefit of ICH harmonization for drug developers?

Higher manufacturing taxes
Reduced need for duplicated studies across regions
Longer regulatory review times
Removal of all regional requirements

Correct Answer: Reduced need for duplicated studies across regions

Q15. Which module of CTD contains clinical study reports and data?

Module 2
Module 3
Module 4
Module 5

Correct Answer: Module 5

Q16. The ICH process step that results in an adopted guideline ready for implementation by regulatory authorities is:

Step 1
Step 2
Step 3
Step 4

Correct Answer: Step 4

Q17. Which guideline series addresses impurities and their control?

Q3 series
E5 series
S1 series
M2 series

Correct Answer: Q3 series

Q18. What is the typical composition of a CTD Module 1?

Non-regional overview and summaries
Regional administrative and prescribing information
Quality data and specifications
Nonclinical study reports

Correct Answer: Regional administrative and prescribing information

Q19. Which ICH topic introduced Quality Risk Management principles?

Correct Answer: Q9

Q20. What is an Observer in the ICH context?

A non-member organization invited to participate without voting rights
A regulatory member with full voting rights
A company that finances ICH meetings
An internal auditor for ICH documents

Correct Answer: A non-member organization invited to participate without voting rights

Q21. Which ICH guideline is primarily concerned with stability testing of new drug substances and products?

Correct Answer: Q1

Q22. Which of the following best describes Step 5 in the ICH process?

Drafting a new guideline text
Formal adoption by regulators and implementation at the national level
Maintenance and periodic review after implementation
Publishing the guideline for public consultation

Correct Answer: Formal adoption by regulators and implementation at the national level

Q23. ICH M4 refers to guidance on:

Pharmacovigilance data exchange
Common Technical Document (CTD) structure
Nonclinical safety testing
Quality risk management

Correct Answer: Common Technical Document (CTD) structure

Q24. Which ICH guideline deals with Good Manufacturing Practice for APIs?

Correct Answer: Q7

Q25. How does ICH promote scientific consensus across regions?

By issuing legally binding international laws
Through collaborative expert working groups and stepwise guideline adoption
By centralizing all drug approvals in a single agency
By eliminating regional regulatory authorities

Correct Answer: Through collaborative expert working groups and stepwise guideline adoption

Q26. Which ICH guideline series covers clinical efficacy topics?

E series
Q series
S series
M series

Correct Answer: E series

Q27. Who adopts and implements ICH Guidelines at the national or regional level?

Individual regulatory authorities (e.g., FDA, EMA, PMDA)
Pharmaceutical companies only
Clinical trial participants
Manufacturing equipment vendors

Correct Answer: Individual regulatory authorities (e.g., FDA, EMA, PMDA)

Q28. Which document provides a standardized electronic format for CTD submissions?

eCTD specification
QMS manual
Pharmacopoeia monograph
Clinical trial protocol template

Correct Answer: eCTD specification

Q29. ICH Q11 provides guidance on:

Development and manufacture of drug substances
Clinical study report writing
Adverse event coding
Nonclinical toxicology methods

Correct Answer: Development and manufacture of drug substances

Q30. What is a common outcome when ICH guidelines are implemented effectively?

Increased fragmentation of global regulations
Improved public health protection and more efficient drug development
Higher costs for basic laboratory reagents only
Elimination of the need for clinical trials

Correct Answer: Improved public health protection and more efficient drug development

G S Sachin

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

Leave a Comment Cancel reply