Regulatory framework and PMDA in Japan – registration and DMF system MCQs With Answer

Introduction

This quiz collection focuses on the regulatory framework and the role of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, with emphasis on drug registration and the Drug Master File (DMF) system. Designed for M.Pharm students, the questions examine practical aspects of marketing authorization, CTD/eCTD submissions, pre-submission consultation, GMP inspections, post-marketing obligations, and confidentiality mechanisms for supplier information through DMFs. The set aims to deepen understanding of Japan-specific regulatory pathways, designation schemes such as Sakigake, and procedural interactions between PMDA and the Ministry of Health, Labour and Welfare (MHLW). Answers are provided for self-assessment and classroom discussion.

Q1. Which organization in Japan is primarily responsible for the scientific review of new drug applications and conducting product-related inspections?

• Ministry of Finance (MOF)
• Pharmaceuticals and Medical Devices Agency (PMDA)
• Japan External Trade Organization (JETRO)
• Japanese Patent Office (JPO)

Correct Answer: Pharmaceuticals and Medical Devices Agency (PMDA)

Q2. Which authority issues the final marketing authorization (approval) for drugs in Japan after PMDA review?

• Pharmaceuticals and Medical Devices Agency (PMDA)
• Ministry of Health, Labour and Welfare (MHLW)
• Cabinet Office
• Regional Prefectural Health Office

Correct Answer: Ministry of Health, Labour and Welfare (MHLW)

Q3. In the Common Technical Document (CTD) format, which module contains detailed information on drug substance and drug product quality (CMC)?

• Module 2 — Common Technical Document Summaries
• Module 3 — Quality (Chemistry, Manufacturing and Controls)
• Module 4 — Nonclinical Study Reports
• Module 5 — Clinical Study Reports

Correct Answer: Module 3 — Quality (Chemistry, Manufacturing and Controls)

Q4. What is the primary purpose of submitting a Drug Master File (DMF) to PMDA in Japan?

• To register a finished product trade name with MHLW
• To provide confidential CMC and manufacturing information that supplier/manufacturer holders can permit applicants to reference during review
• To obtain a pharmaceutical price listing
• To replace clinical study reports in the NDA

Correct Answer: To provide confidential CMC and manufacturing information that supplier/manufacturer holders can permit applicants to reference during review

Q5. Which entities are eligible to submit a DMF (or equivalent confidential dossier) to the PMDA?

• Only marketing authorization holders (MAHs)
• API manufacturers, excipient suppliers, and other holders of proprietary manufacturing information
• Only university research laboratories
• Only foreign regulatory authorities

Correct Answer: API manufacturers, excipient suppliers, and other holders of proprietary manufacturing information

Q6. How does an applicant normally enable PMDA to review confidential DMF information during an NDA review?

• By attaching a public summary of the DMF in Module 3
• By providing a formal letter of authorization/letter of access from the DMF holder to the applicant and PMDA
• By submitting the full DMF as part of Module 1 without consent
• By verbally informing PMDA during consultation meetings

Correct Answer: By providing a formal letter of authorization/letter of access from the DMF holder to the applicant and PMDA

Q7. What is the Sakigake designation in Japan?

• A system to waive all clinical trials for generics
• A Japanese designation to promote early practical application offering prioritized review and enhanced consultations for innovative therapies developed first in Japan
• A post-marketing risk management plan
• A manufacturing GMP exemption for small companies

Correct Answer: A Japanese designation to promote early practical application offering prioritized review and enhanced consultations for innovative therapies developed first in Japan

Q8. Which submission format is the regulatory standard for New Drug Applications to PMDA?

• Paper CTD only
• Electronic Common Technical Document (eCTD)
• MS Word files submitted by email
• PDF portfolios with no specific structure

Correct Answer: Electronic Common Technical Document (eCTD)

Q9. The Pharmaceuticals and Medical Devices Act (PMD Act) in Japan covers which of the following product categories?

• Only prescription drugs
• Drugs, medical devices, regenerative medicine products and cosmetics
• Food and dietary supplements exclusively
• Pesticides and veterinary medicines only

Correct Answer: Drugs, medical devices, regenerative medicine products and cosmetics

Q10. What is the purpose of Japan’s re-examination system for newly approved drugs?

• To automatically renew marketing authorization every year
• To conduct a defined post-marketing evaluation period during which additional data on safety and effectiveness are collected to confirm benefit-risk
• To test the manufacturing process in a pilot batch only
• To set the retail price for insurance reimbursement

Correct Answer: To conduct a defined post-marketing evaluation period during which additional data on safety and effectiveness are collected to confirm benefit-risk

Q11. Who typically conducts GMP inspections of foreign manufacturing sites supplying drugs to Japan?

• Prefectural pharmaceutical inspectors only
• Pharmaceuticals and Medical Devices Agency (PMDA) inspectors or PMDA-coordinated teams on behalf of MHLW
• World Health Organization inspection teams
• Local distributor representatives

Correct Answer: Pharmaceuticals and Medical Devices Agency (PMDA) inspectors or PMDA-coordinated teams on behalf of MHLW

Q12. When referencing a European Pharmacopoeia Certificate of Suitability (CEP) for an API in a Japanese application, what is typically required?

• No additional documents; CEP alone is sufficient
• A copy of the CEP plus bridging information and authorization from the CEP holder to allow PMDA review
• An independent Japanese re-test of the API only
• Submission of the full manufacturing process with public disclosure

Correct Answer: A copy of the CEP plus bridging information and authorization from the CEP holder to allow PMDA review

Q13. Which post-marketing periodic report format is used in Japan to summarize safety information for marketed drugs?

• Periodic Safety Update Report (PSUR)
• Quality Target Product Profile (QTPP)
• Clinical Study Protocol (CSP)
• Good Laboratory Practice Report (GLPR)

Correct Answer: Periodic Safety Update Report (PSUR)

Q14. What is the main benefit of requesting a pre-submission consultation with PMDA?

• To obtain immediate approval without review
• To clarify required data, regulatory expectations, and review strategy to reduce review deficiencies and facilitate efficient submission
• To secure pricing and reimbursement details
• To change the product monograph after approval

Correct Answer: To clarify required data, regulatory expectations, and review strategy to reduce review deficiencies and facilitate efficient submission

Q15. Which category of products in Japan has a specific conditional and time-limited approval pathway to accelerate patient access?

• Over-the-counter (OTC) drugs
• Regenerative medicine products
• Cosmetics
• Vaccines only

Correct Answer: Regenerative medicine products

Q16. Which of the following best describes why confidentiality of DMF content is important for suppliers?

• To allow public access to manufacturing trade secrets
• To protect proprietary manufacturing processes and quality control data while enabling multiple applicants to reference the information under authorization
• To circumvent regulatory inspections
• To avoid any documented quality requirements

Correct Answer: To protect proprietary manufacturing processes and quality control data while enabling multiple applicants to reference the information under authorization

Q17. Which authority in Japan issues the Certificate of Pharmaceutical Product (CPP) used for international regulatory purposes?

• Local prefectural office where product is sold
• Ministry of Health, Labour and Welfare (MHLW)
• Pharmaceuticals and Medical Devices Agency (PMDA) without MHLW involvement
• Japan External Trade Organization (JETRO)

Correct Answer: Ministry of Health, Labour and Welfare (MHLW)

Q18. What type of information is typically included in Module 1 of the eCTD for a Japanese submission?

• Nonclinical pharmacology and toxicology study reports
• Regional administrative information, application forms, labeling, and regional-specific documents
• Quality control test methods and validation data
• Integrated summaries of clinical safety and efficacy

Correct Answer: Regional administrative information, application forms, labeling, and regional-specific documents

Q19. If a DMF holder refuses to provide an applicant with a letter of authorization to reference the DMF, what is the likely regulatory consequence for the applicant’s submission?

• The application is automatically approved without DMF data
• The applicant must provide full CMC/manufacturing data in their own submission or select an alternative supplier that provides authorization
• The PMDA will accept a verbal promise
• The application can reference the DMF without any authorization in an emergency

Correct Answer: The applicant must provide full CMC/manufacturing data in their own submission or select an alternative supplier that provides authorization

Q20. Which Japanese guidance document should applicants consult for technical expectations and procedural aspects of DMF submissions?

• Guideline on Clinical Trial Design for Generics
• Guideline on Drug Master File (DMF) submissions published by MHLW/PMDA
• Japanese Taxation Guidance for Pharmaceutical Companies
• Guidance on Cosmetic Ingredient Safety Only

Correct Answer: Guideline on Drug Master File (DMF) submissions published by MHLW/PMDA

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