Global NDA submission process MCQs With Answer

Introduction

Global NDA submission process MCQs With Answer is designed for M.Pharm students to deepen understanding of regulatory strategies required for bringing new drug applications (NDAs) to international markets. This concise quiz set covers core concepts such as eCTD structure, regulatory agency expectations (FDA, EMA, PMDA), pivotal clinical data requirements, nonclinical and CMC dossier elements, pre-submission meetings, accelerated pathways, pharmacovigilance obligations, and post-marketing commitments. Each question emphasizes practical decision-making and dossier planning that a regulatory affairs professional or clinical pharmacologist must master. Use these MCQs to evaluate knowledge, prepare for exams, and strengthen skills needed for global regulatory submissions.

Q1. What is the primary purpose of an NDA (New Drug Application) in the context of global regulatory submissions?

• To request market exclusivity only in the country of origin
• To obtain regulatory approval to market a new drug based on evidence of safety and efficacy
• To register a manufacturing site for active pharmaceutical ingredients
• To secure research funding for late-stage clinical trials

Correct Answer: To obtain regulatory approval to market a new drug based on evidence of safety and efficacy

Q2. Which standardized format is commonly required by major regulatory authorities for electronic submission of NDAs?

• PDF-only Dossier Format
• eCTD (electronic Common Technical Document)
• XML Regulatory Exchange Standard (XRES)
• ICH-SMART Archive

Correct Answer: eCTD (electronic Common Technical Document)

Q3. Which module of the Common Technical Document (CTD) contains clinical study reports and summaries of clinical efficacy and safety?

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

Correct Answer: Module 5

Q4. What is the main focus of Module 3 in an eCTD submission?

• Administrative and regional information
• Nonclinical study reports
• Quality (Chemistry, Manufacturing and Controls)
• Clinical summaries and reports

Correct Answer: Quality (Chemistry, Manufacturing and Controls)

Q5. In a global NDA strategy, what is a key benefit of conducting a pre-NDA (or pre-submission) meeting with a regulatory authority?

• Guarantees accelerated approval upon submission
• Provides binding legal guidance on labeling text
• Allows discussion of pivotal trial design and deficiencies before formal submission
• Replaces the need for submitting Module 4 toxicology data

Correct Answer: Allows discussion of pivotal trial design and deficiencies before formal submission

Q6. Which regulatory pathway is intended to shorten review times for drugs that offer significant improvements over available therapies?

• Standard Review
• Priority Review / Accelerated Assessment
• Orphan Drug Designation
• Marketing Authorization Renewal

Correct Answer: Priority Review / Accelerated Assessment

Q7. For biologic products, which additional regulatory consideration is typically crucial in the NDA/BLA submission for global approvals?

• Photostability testing in tropical climates only
• Comparability and immunogenicity assessment across manufacturing changes
• Exclusion of any nonclinical pharmacology data
• Submission of only Phase I human data

Correct Answer: Comparability and immunogenicity assessment across manufacturing changes

Q8. What is the role of a Pediatric Investigation Plan (PIP) or Pediatric Study Plan in global NDA submissions?

• To request exemption from stability testing
• To outline proposed pediatric studies and timelines required by some authorities
• To provide financial projections for pediatric market launch
• To replace adult efficacy data with pediatric-only trials

Correct Answer: To outline proposed pediatric studies and timelines required by some authorities

Q9. Which element is considered essential for demonstrating global regulatory compliance for manufacturing sites?

• Local branding and packaging artwork
• GMP certificates and site inspection readiness
• Only final product release data without process description
• Clinical investigator credentials

Correct Answer: GMP certificates and site inspection readiness

Q10. In the context of global NDAs, what is a “rolling review”?

• A continuous marketing campaign during clinical phases
• A submission process where sections of the dossier are reviewed by regulators as they become available
• A method for filing patents in multiple jurisdictions simultaneously
• A post-approval labeling update cycle

Correct Answer: A submission process where sections of the dossier are reviewed by regulators as they become available

Q11. Which of the following best describes a risk evaluation and mitigation strategy (REMS) in a global regulatory context?

• An optional marketing plan to increase sales post-approval
• A mandatory program to manage known or potential safety risks associated with a drug
• A manufacturing quality improvement plan only
• A clinical trial recruitment strategy

Correct Answer: A mandatory program to manage known or potential safety risks associated with a drug

Q12. What is a major regulatory challenge when using foreign clinical data to support a global NDA?

• Foreign data are always accepted without additional validation
• Potential differences in patient population, standard of care, and trial conduct that may affect acceptability
• It eliminates the need for local labeling negotiations
• It bypasses the need for CMC documentation

Correct Answer: Potential differences in patient population, standard of care, and trial conduct that may affect acceptability

Q13. Which submission component specifically addresses pharmacokinetics, bioavailability, and bioequivalence data?

• Module 1
• Module 3
• Module 4
• Module 5

Correct Answer: Module 5

Q14. What regulatory designation can provide incentives such as fee waivers and market exclusivity for rare disease drugs during global NDA submissions?

• Accelerated Approval
• Orphan Drug Designation
• Priority Review Voucher
• Breakthrough Therapy Designation

Correct Answer: Orphan Drug Designation

Q15. When preparing stability data for an NDA intended for multiple climatic regions, what guideline principle should be applied?

• Stability testing only at room temperature is sufficient
• Follow ICH guidelines for zone-specific long-term and accelerated stability conditions
• Use stability data from any single country without justification
• Exclude photostability studies for coated tablets

Correct Answer: Follow ICH guidelines for zone-specific long-term and accelerated stability conditions

Q16. Which of the following is a critical element of the CMC section to demonstrate product consistency for biologicals?

• Only a schematic of the cell bank location
• Characterization of critical quality attributes and process validation data
• Marketing plans for distribution channels
• Copies of investigators’ informed consent forms

Correct Answer: Characterization of critical quality attributes and process validation data

Q17. What is the significance of an integrated summary of safety (ISS) in an NDA dossier?

• It compiles and analyzes safety data from all clinical trials to present an overall safety profile
• It summarizes only nonclinical toxicology findings
• It provides the final proposed product labeling without data support
• It details the manufacturing site floor plans

Correct Answer: It compiles and analyzes safety data from all clinical trials to present an overall safety profile

Q18. For expedited approval programs, which post-marketing obligation is commonly required by regulators?

• No further trials or data collection ever required
• Conduct of confirmatory post-marketing studies to validate clinical benefit
• Immediate withdrawal of the product after five years
• Only additional stability studies with no clinical follow-up

Correct Answer: Conduct of confirmatory post-marketing studies to validate clinical benefit

Q19. What is a major difference between an NDA for a small-molecule drug and a BLA (Biologics License Application) for a biologic, relevant to global submissions?

• BLAs never require clinical data
• BLAs place greater emphasis on manufacturing process, cell line characterization, and immunogenicity
• NDAs always require pediatric exclusivity
• NDAs do not include Module 3 information

Correct Answer: BLAs place greater emphasis on manufacturing process, cell line characterization, and immunogenicity

Q20. Which documentation is essential to demonstrate external validity and applicability of pivotal trial results during a global NDA review?

• Complete protocol and statistical analysis plan, patient demographics, subgroup analyses, and trial conduct details
• Only the headline efficacy estimate without supporting appendices
• Marketing authorization letters from local distributors
• Only animal model efficacy data

Correct Answer: Complete protocol and statistical analysis plan, patient demographics, subgroup analyses, and trial conduct details

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