ASEAN Common Technical Document (ACTD) MCQs With Answer

ASEAN Common Technical Document (ACTD) MCQs With Answer is an essential study resource for B. Pharm students preparing for regulatory affairs and drug registration roles. The ACTD harmonizes dossier structure across ASEAN countries, aligning quality, nonclinical and clinical modules with international CTD principles while keeping regional Module 1 requirements. Key keywords include ACTD, ASEAN Common Technical Document, regulatory submissions, pharmaceutical dossiers, drug registration, Module 1, Module 3 quality, bioequivalence, stability, GMP and pharmacovigilance. This focused set of MCQs delves into dossier content, module specifics, data requirements and common regulatory expectations to strengthen your understanding. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of the ASEAN Common Technical Document (ACTD)?

• To provide a single ASEAN pharmacopoeia
• To harmonize the structure and content of regulatory dossiers for drug registration across ASEAN
• To replace national GMP inspections
• To mandate electronic submission only

Correct Answer: To harmonize the structure and content of regulatory dossiers for drug registration across ASEAN

Q2. Which module of the ACTD contains region-specific administrative and prescribing information?

• Module 1
• Module 2
• Module 3
• Module 5

Correct Answer: Module 1

Q3. Which ACTD module provides the Quality Overall Summary and detailed quality documentation?

• Module 1
• Module 2
• Module 3
• Module 4

Correct Answer: Module 3

Q4. Where in the ACTD would you place clinical study reports and datasets?

• Module 2 summaries
• Module 3 quality section
• Module 4 nonclinical reports
• Module 5 clinical study reports

Correct Answer: Module 5 clinical study reports

Q5. Which section of Module 3 typically contains the description of the drug substance manufacture and controls?

• 3.2.P.1
• 3.2.S.2
• 3.2.S.3
• 3.2.P.2

Correct Answer: 3.2.S.3

Q6. The Quality Overall Summary (QOS) is located in which part of the ACTD?

• Module 1 administrative documents
• Module 2
• Module 4 toxicology data
• Module 5 clinical overview

Correct Answer: Module 2

Q7. What is the commonly accepted bioequivalence statistical acceptance range for AUC and Cmax for most generic approvals?

• 50–150%
• 75–135%
• 80–125%
• 90–110%

Correct Answer: 80–125%

Q8. What does a Certificate of Pharmaceutical Product (CPP) demonstrate in regulatory submissions?

• Proof of stability for five years
• Authorization of the product in the exporting country
• Bioequivalence equivalence
• Manufacturing facility ownership

Correct Answer: Authorization of the product in the exporting country

Q9. Which international guideline defines the CTD format that ACTD aligns with?

• ICH M4
• ICH Q8
• WHO Good Regulatory Practices
• ISO 9001

Correct Answer: ICH M4

Q10. Where are pharmacovigilance and post-marketing safety system details usually described in the ACTD?

• Module 1.8
• Module 2.3
• Module 3.2.P.8
• Module 5.3

Correct Answer: Module 1.8

Q11. Which module contains nonclinical pharmacology and toxicology study reports?

• Module 1
• Module 2
• Module 4
• Module 3

Correct Answer: Module 4

Q12. For analytical method validation data of the drug substance, which section is most appropriate in the ACTD?

• 3.2.S.4
• 3.2.P.5
• 2.3
• 5.3

Correct Answer: 3.2.S.4

Q13. Which guideline family addresses qualification and control of impurities in drug substances and drug products?

• ICH Q3A/Q3B
• ICH Q1A
• ICH Q6A
• ICH E6

Correct Answer: ICH Q3A/Q3B

Q14. A biowaiver based on the Biopharmaceutics Classification System (BCS) is most often accepted for which class?

• BCS Class II (low solubility, high permeability)
• BCS Class I (high solubility, high permeability)
• BCS Class IV (low solubility, low permeability)
• BCS Class III (high solubility, low permeability)

Correct Answer: BCS Class I (high solubility, high permeability)

Q15. Details of the container closure system for the finished product are typically filed in which subsection?

• 3.2.P.1
• 3.2.P.7
• 3.2.S.2
• 5.3.5

Correct Answer: 3.2.P.7

Q16. Which document in the ACTD provides an overview of nonclinical and clinical evidence to support safety?

• Module 1 administrative forms
• Module 2 summaries (nonclinical and clinical overviews)
• Module 3 drug product specs
• Module 4 raw data appendices only

Correct Answer: Module 2 summaries (nonclinical and clinical overviews)

Q17. Which type of studies must comply with GLP to be accepted in Module 4 submissions?

• Clinical pharmacokinetic studies
• Nonclinical toxicology studies
• Stability studies
• Analytical method validation

Correct Answer: Nonclinical toxicology studies

Q18. For a generic immediate-release oral solid product, which two documents are most critical for regulatory approval in ACTD?

• Marketing plan and sales forecast
• Manufacturing process flow chart and facility lease
• Quality dossier (Module 3) and bioequivalence study report (Module 5)
• Packaging artwork only

Correct Answer: Quality dossier (Module 3) and bioequivalence study report (Module 5)

Q19. Which ACTD module would include the description and justification of the proposed shelf life and storage conditions?

• Module 1.3
• Module 3.2.P.8
• Module 2.5
• Module 4.2

Correct Answer: Module 3.2.P.8

Q20. Which section in Module 3 deals specifically with the pharmaceutical development and composition of the drug product?

• 3.2.P.1
• 3.2.P.2
• 3.2.P.3
• 3.2.S.4

Correct Answer: 3.2.P.2

Q21. What is one major advantage of using the ACTD format for ASEAN submissions?

• It removes all national requirements
• It eliminates the need for clinical data
• It reduces duplication and streamlines dossier preparation across multiple countries
• It guarantees faster approval times

Correct Answer: It reduces duplication and streamlines dossier preparation across multiple countries

Q22. Which section typically contains the manufacturing batch release and batch analysis data for the finished product?

• 3.2.P.4
• 3.2.S.5
• 2.4
• 1.2

Correct Answer: 3.2.P.4

Q23. Which ACTD module would you consult for detailed clinical summaries and benefit-risk assessment?

• Module 1
• Module 2
• Module 3
• Module 4

Correct Answer: Module 2

Q24. Where should stability study protocols and reports for the drug substance be placed?

• 3.2.S.7
• 1.5
• 2.3.2
• 5.2

Correct Answer: 3.2.S.7

Q25. What is the role of an administrative dossier checklist in Module 1?

• To replace analytical validation data
• To ensure all required regional administrative documents and forms are included
• To provide clinical trial raw data
• To define manufacturing process steps

Correct Answer: To ensure all required regional administrative documents and forms are included

Q26. A Periodic Safety Update Report (PSUR) relates to which aspect of a marketed product?

• Quality control release testing
• Ongoing pharmacovigilance and safety evaluation
• Manufacturing site validation
• Bioequivalence waiver justification

Correct Answer: Ongoing pharmacovigilance and safety evaluation

Q27. Which part of the ACTD would include dissolution method and results supporting product performance?

• 3.2.P.5.3
• 1.1
• 4.1
• 5.3

Correct Answer: 3.2.P.5.3

Q28. If a stability study demonstrates significant degradation under accelerated conditions, what must the applicant do in the ACTD?

• Ignore the data and submit only long-term results
• Provide degradation pathway, identification of degradants and justify shelf life
• Reduce the proposed batch size
• Change the manufacturing license holder

Correct Answer: Provide degradation pathway, identification of degradants and justify shelf life

Q29. Which ACTD section commonly contains the summaries of clinical pharmacology, efficacy and safety?

• 2.4 Clinical overview and summaries in Module 2
• 3.2.S.4
• 1.7
• 4.3

Correct Answer: 2.4 Clinical overview and summaries in Module 2

Q30. Which guideline should be consulted for setting specification limits and analytical procedures accepted in CTD/ACTD dossiers?

• ICH Q6A
• ICH M4
• ICH E2A
• ISO 13485

Correct Answer: ICH Q6A

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