Approval procedures and documentation for new drug applications MCQs With Answer

Approval procedures and documentation for new drug applications introduce B. Pharm students to the regulatory framework, dossier structure, and evidence required to gain market authorization. This topic covers NDA/ANDA/505(b)(2) pathways, IND filings, CTD/eCTD format, CMC (Chemistry, Manufacturing & Controls), nonclinical and clinical data, bioavailability/bioequivalence studies, stability, GMP, pharmacovigilance and risk management plans. Understanding regulatory authorities (FDA, EMA, CDSCO), expedited programs, exclusivity, patent linkage and common dossier deficiencies is essential for preparing robust submissions. Practical knowledge of documentation, electronic submissions, regulatory meetings and post‑approval obligations helps ensure compliance and patient safety. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What does NDA stand for in regulatory submissions?

• New Drug Application
• New Device Application
• National Drug Authorization
• Nonclinical Data Archive

Correct Answer: New Drug Application

Q2. What is the primary purpose of an Investigational New Drug (IND) application?

• To request marketing approval for a drug
• To obtain permission to conduct clinical trials in humans
• To register a generic product
• To apply for orphan drug status

Correct Answer: To obtain permission to conduct clinical trials in humans

Q3. How many modules are there in the Common Technical Document (CTD) structure?

• 3 modules
• 4 modules
• 5 modules
• 6 modules

Correct Answer: 5 modules

Q4. What does eCTD refer to?

• electronic Clinical Trial Data
• electronic Common Technical Document
• enhanced Chemistry, Toxicology Document
• evidence for Clinical Trial Design

Correct Answer: electronic Common Technical Document

Q5. In regulatory terminology, CMC stands for:

• Chemistry, Manufacturing and Controls
• Clinical, Medical and Compliance
• Control, Monitoring and Certification
• Chemical Methods and Characterization

Correct Answer: Chemistry, Manufacturing and Controls

Q6. Which type of clinical trial data is usually considered pivotal for demonstrating efficacy in an NDA?

• Phase I pharmacokinetic trials
• Phase II dose-ranging trials
• Phase III randomized controlled trials
• Post‑marketing surveillance studies

Correct Answer: Phase III randomized controlled trials

Q7. Stability studies in a new drug application are performed primarily to:

• Determine optimal tablet color
• Establish shelf life and storage conditions
• Replace clinical efficacy data
• Assess market demand

Correct Answer: Establish shelf life and storage conditions

Q8. What is the main goal of a bioequivalence study?

• To compare manufacturing processes
• To show two products have equivalent pharmacokinetic profiles
• To evaluate toxicology in animals
• To prove superiority of a new formulation

Correct Answer: To show two products have equivalent pharmacokinetic profiles

Q9. Which regulatory authority is the Central Drugs Standard Control Organization?

• United States FDA
• European Medicines Agency
• India’s national regulator
• World Health Organization committee

Correct Answer: India’s national regulator

Q10. Which program is intended to expedite development and review for serious conditions with unmet medical need?

• Fast Track designation
• Generic approval pathway
• Standard marketing authorization
• Pharmacopoeial monograph process

Correct Answer: Fast Track designation

Q11. A 505(b)(2) application in the US is characterized by:

• Being the same as an ANDA for generics
• Relying in part on existing published or previously submitted data
• Exempting the applicant from clinical studies
• Only applicable to biological products

Correct Answer: Relying in part on existing published or previously submitted data

Q12. ANDA stands for and is filed for:

• Abbreviated New Drug Application for generic drug approval
• Advanced New Drug Application for novel drugs
• Alternative New Device Application for medical devices
• Authorization for New Dietary Additives

Correct Answer: Abbreviated New Drug Application for generic drug approval

Q13. Which CTD module contains pharmacology and toxicology studies?

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

Correct Answer: Module 4

Q14. A common regulatory deficiency in NDAs is:

• Excessive clinical efficacy data
• Incomplete stability and shelf‑life information
• Too many manufacturing sites listed
• Overly detailed labeling text

Correct Answer: Incomplete stability and shelf‑life information

Q15. The regulatory document that outlines post‑approval safety monitoring and risk minimization is called:

• Clinical Study Report
• Risk Management Plan (RMP)
• Certificates of Analysis
• Manufacturing Batch Record

Correct Answer: Risk Management Plan (RMP)

Q16. Which plan is required by EMA to address pediatric development of a new medicine?

• Pediatric Investigation Plan (PIP)
• Child Safety Dossier (CSD)
• Pediatric Authorization Request (PAR)
• Infant Use Protocol (IUP)

Correct Answer: Pediatric Investigation Plan (PIP)

Q17. In the United States, orphan drug designation generally grants how many years of market exclusivity?

• 3 years
• 5 years
• 7 years
• 10 years

Correct Answer: 7 years

Q18. What is the main benefit of requesting a pre‑IND meeting with a regulatory agency?

• To obtain immediate marketing approval
• To discuss and align on clinical and development plans
• To shorten drug manufacturing time
• To register patents internationally

Correct Answer: To discuss and align on clinical and development plans

Q19. During NDA review, regulators perform a benefit‑risk assessment. This primarily evaluates:

• Manufacturing cost versus sales price
• Safety and efficacy compared to risks
• Company financial stability
• Number of clinical sites used

Correct Answer: Safety and efficacy compared to risks

Q20. A therapeutic equivalence rating for an approved generic is based largely on:

• Bioequivalence study results
• Price comparison with branded product
• Packaging similarities
• Advertising claims

Correct Answer: Bioequivalence study results

Q21. The eCTD submission allows sponsors to:

• Submit paper dossiers with digital signatures
• Make encrypted phone calls to regulators
• Transmit regulatory dossier electronically in a standardized format
• Bypass regional regulatory requirements

Correct Answer: Transmit regulatory dossier electronically in a standardized format

Q22. A Certificate of Pharmaceutical Product (CPP) is typically used to:

• Document clinical trial recruitment
• Support export and registration in foreign countries
• Prove origin of raw materials
• Register a manufacturing site locally

Correct Answer: Support export and registration in foreign countries

Q23. Which CTD module contains quality (CMC) information?

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

Correct Answer: Module 3

Q24. Regulatory user fees charged at the time of NDA submission are intended to:

• Provide marketing support for the sponsor
• Cover agency review costs and resources
• Replace the need for clinical trials
• Fund private advertising campaigns

Correct Answer: Cover agency review costs and resources

Q25. A rolling review process allows a company to:

• Submit modules of the dossier as they become available
• Request multiple market authorizations at once
• Complete all regulatory inspections after approval
• Avoid submitting CMC information

Correct Answer: Submit modules of the dossier as they become available

Q26. A bridging study is conducted to:

• Connect two manufacturing lines within the same site
• Extrapolate foreign clinical data to a local population
• Bridge the gap between two patent expiry dates
• Compare two unrelated drugs

Correct Answer: Extrapolate foreign clinical data to a local population

Q27. The primary endpoint in a pivotal clinical trial is:

• An exploratory biomarker with no regulatory relevance
• The main outcome used to judge treatment benefit
• A manufacturing quality attribute
• A secondary safety measurement only

Correct Answer: The main outcome used to judge treatment benefit

Q28. GMP in the context of drug approval stands for:

• Good Marketing Policy
• Good Manufacturing Practice
• General Medical Protocol
• Guaranteed Market Protection

Correct Answer: Good Manufacturing Practice

Q29. Patent linkage refers to:

• Tying regulatory approval timelines to the status of patent exclusivity
• Linking clinical endpoints to patent claims
• Combining two patents into one
• Registering a patent with the pharmacopoeia

Correct Answer: Tying regulatory approval timelines to the status of patent exclusivity

Q30. A stability‑indicating analytical method is one that:

• Only measures the active ingredient without impurities
• Can specifically detect degradation products and quantify the drug
• Is used exclusively for biological products
• Replaces the need for long‑term stability studies

Correct Answer: Can specifically detect degradation products and quantify the drug

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