Regulatory system of Japan (PMDA) MCQs With Answer

Understanding the regulatory system of Japan, especially the role of the Pharmaceuticals and Medical Devices Agency (PMDA), is essential for B. Pharm students. This concise guide covers Japan’s drug approval pathway, clinical trial notification, dossier submission (eCTD/CTD), pharmacovigilance, post-marketing surveillance, GMP/GCP/GLP expectations, Sakigake and orphan drug pathways, risk management plans, regulatory inspections, and marketing authorization holder (MAH) responsibilities. Familiarity with PMDA review processes, safety reporting timelines, re-examination, and international harmonization (ICH) prepares students for careers in regulatory affairs, quality assurance, clinical research, and drug safety. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary role of the PMDA in Japan?

• To manufacture pharmaceuticals for hospitals
• To regulate and review pharmaceuticals and medical devices for safety and efficacy
• To distribute medicines to pharmacies
• To provide clinical services to patients

Correct Answer: To regulate and review pharmaceuticals and medical devices for safety and efficacy

Q2. Which dossier format is commonly used for regulatory submissions to PMDA?

• eCTD (electronic Common Technical Document)
• PDF-Only Submission
• Paper-only IND
• CSV Clinical Dataset

Correct Answer: eCTD (electronic Common Technical Document)

Q3. What does MAH stand for in the Japanese regulatory context?

• Medical Approval Head
• Marketing Authorization Holder
• Manufacturing and Handling
• Medical Affairs Head

Correct Answer: Marketing Authorization Holder

Q4. Which guideline harmonization body’s recommendations are heavily referenced by PMDA?

• OECD
• ICH (International Council for Harmonisation)
• ISO
• WHO only

Correct Answer: ICH (International Council for Harmonisation)

Q5. Which Japanese pathway accelerates review for innovative medicines with high public health need?

• Re-examination Period
• Sakigake Designation
• Generic Route
• Standard Review

Correct Answer: Sakigake Designation

Q6. What is the primary purpose of post-marketing surveillance (PMS) in Japan?

• To conduct pre-clinical animal testing
• To monitor safety and effectiveness after a product is marketed
• To advertise new drugs to doctors
• To replace clinical trials

Correct Answer: To monitor safety and effectiveness after a product is marketed

Q7. Which regulatory standard focuses on clinical trial conduct in Japan?

• GMP (Good Manufacturing Practice)
• GCP (Good Clinical Practice)
• GLP (Good Laboratory Practice)
• GDP (Good Distribution Practice)

Correct Answer: GCP (Good Clinical Practice)

Q8. For reporting serious adverse drug reactions in Japan, which activity is essential for MAHs?

• Monthly advertising campaigns
• Timely safety signal detection and expedited reporting to PMDA
• Submitting manufacturing batch records only
• Conducting patient support programs

Correct Answer: Timely safety signal detection and expedited reporting to PMDA

Q9. What is a common requirement before initiating a clinical trial in Japan?

• Marketing authorization for the drug
• Clinical trial notification or approval process under relevant laws
• Completion of post-marketing surveillance
• Local manufacturing license

Correct Answer: Clinical trial notification or approval process under relevant laws

Q10. What does GLP primarily ensure in non-clinical studies?

• Safety and quality of commercial batches
• Integrity and reliability of non-clinical laboratory data
• Ethical treatment of clinical trial volunteers
• Accuracy of marketing materials

Correct Answer: Integrity and reliability of non-clinical laboratory data

Q11. Which of the following is a key element of a Risk Management Plan (RMP) submitted to PMDA?

• Marketing strategy for drug launch
• Identification of important risks and planned pharmacovigilance activities
• Cost analysis of clinical trials
• Design of manufacturing facility

Correct Answer: Identification of important risks and planned pharmacovigilance activities

Q12. What is the purpose of the re-examination period in Japan?

• To finalize drug pricing only
• To monitor long-term safety and effectiveness after approval
• To ban foreign companies from the market
• To test manufacturing equipment

Correct Answer: To monitor long-term safety and effectiveness after approval

Q13. Which regulatory document contains quality, safety, and efficacy modules for submission?

• Manufacturing SOP
• CTD (Common Technical Document)
• Patient brochure
• Marketing plan

Correct Answer: CTD (Common Technical Document)

Q14. How does PMDA interact with foreign clinical trial data?

• Always rejects foreign data
• May accept foreign data if it meets scientific and ethical standards or bridging studies are provided
• Only accepts trials from Japanese investigators
• Requires all trials to be repeated in Japan

Correct Answer: May accept foreign data if it meets scientific and ethical standards or bridging studies are provided

Q15. Which inspection focuses on manufacturing compliance for pharmaceuticals?

• IRB inspection
• GMP inspection by regulatory authorities
• GCP inspection
• Market surveillance audit

Correct Answer: GMP inspection by regulatory authorities

Q16. What designation helps a drug for rare diseases receive special review in Japan?

• Generic designation
• Orphan drug designation
• Over-the-counter status
• Conditional withdrawal

Correct Answer: Orphan drug designation

Q17. Which entity provides ethics oversight for clinical trials in Japan?

• Pharmaceutical company CEO
• Institutional Review Board (IRB) or Certified Review Board
• Marketing Authorization Holder alone
• Local pharmacy association

Correct Answer: Institutional Review Board (IRB) or Certified Review Board

Q18. What is the role of the Japanese Pharmacopoeia (JP) in regulation?

• Sets clinical trial protocols
• Provides official quality standards for medicines and excipients
• Determines hospital formularies
• Manages drug pricing

Correct Answer: Provides official quality standards for medicines and excipients

Q19. Which activity is part of pharmacovigilance under PMDA guidance?

• Designing packaging artwork
• Signal detection, assessment, and safety communication
• Selling samples to clinics
• Recruiting clinical trial subjects

Correct Answer: Signal detection, assessment, and safety communication

Q20. What is a major advantage of early consultation with PMDA?

• Guaranteed approval regardless of data
• Clarifies regulatory expectations and can streamline development
• Removes need for clinical data
• Eliminates GMP inspections

Correct Answer: Clarifies regulatory expectations and can streamline development

Q21. Under Japanese law, who is primarily responsible for reporting adverse events to PMDA?

• Hospital administrative staff only
• Marketing Authorization Holder (MAH) and healthcare professionals
• Patients’ families exclusively
• Retail pharmacists only

Correct Answer: Marketing Authorization Holder (MAH) and healthcare professionals

Q22. What does GCP require regarding informed consent?

• No consent needed for observational studies
• Participants must give informed consent before trial procedures
• Consent may be verbal only for all trials
• Consent is required only after trial completion

Correct Answer: Participants must give informed consent before trial procedures

Q23. Which regulatory action can PMDA request if new risks emerge post-approval?

• Change in clinical trial protocol only
• Label changes, restricted distribution, additional studies, or recalls
• Immediate revocation of all MAHs globally
• Free distribution of the product

Correct Answer: Label changes, restricted distribution, additional studies, or recalls

Q24. What is the typical focus of GCP inspections by PMDA?

• Laboratory animal welfare
• Conduct and documentation of clinical trials and data integrity
• Advertising practices only
• Manufacturing site sterility

Correct Answer: Conduct and documentation of clinical trials and data integrity

Q25. Which submission is necessary to start human clinical trials in Japan?

• NDA for full marketing approval
• Clinical trial notification or IND-equivalent submission with required documents
• Post-marketing surveillance report
• GMP certificate only

Correct Answer: Clinical trial notification or IND-equivalent submission with required documents

Q26. What does PMDA assess during a marketing authorization review?

• Only the naming of the product
• Safety, efficacy, and quality data in the submission
• Solely production costs
• Only the promotional materials

Correct Answer: Safety, efficacy, and quality data in the submission

Q27. Which concept ensures pharmaceutical manufacturing consistency?

• Clinical endpoint selection
• GMP (Good Manufacturing Practice)
• Post-marketing study design
• Ethics committee approval

Correct Answer: GMP (Good Manufacturing Practice)

Q28. How does PMDA contribute to international regulatory collaboration?

• By isolating Japan’s practices from global standards
• By participating in ICH and information-sharing with other regulators
• By rejecting harmonized guidelines
• By allowing only domestic clinical data

Correct Answer: By participating in ICH and information-sharing with other regulators

Q29. What is an important regulatory consideration for medical devices in Japan?

• Devices never require classification or conformity assessment
• Device classification determines the premarket review route and requirements
• All devices follow the same drug NDA process
• Clinical data are never needed for devices

Correct Answer: Device classification determines the premarket review route and requirements

Q30. Which activity is central to a PMDA-style re-evaluation after launch?

• Ignoring post-marketing data
• Reviewing accumulated safety and effectiveness data to confirm benefit-risk profile
• Only checking packaging labels
• Canceling the product automatically

Correct Answer: Reviewing accumulated safety and effectiveness data to confirm benefit-risk profile

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