Product registration guidelines – CDSCO, USFDA MCQs With Answer

Introduction: Product registration guidelines – CDSCO, USFDA MCQs With Answer is designed for M.Pharm students preparing for regulatory affairs and product development examinations. This collection explains key principles of drug registration in India and the United States, covering dossier formats, submission pathways, quality and clinical requirements, post-approval changes, and pharmacovigilance expectations. The questions focus on CDSCO and USFDA frameworks such as CTD/eCTD structure, ANDA/NDA/BLA pathways, DMFs, bioequivalence, stability guidance, and regulatory designations like Priority Review and Fast Track. Practicing these MCQs will strengthen conceptual understanding and help students apply regulatory concepts during technology transfer and product development activities.

Q1. Which organization is the primary national regulatory authority for drugs and medical devices in India?

• Food Safety and Standards Authority of India (FSSAI)
• Central Drugs Standard Control Organization (CDSCO)
• Pharmaceuticals Export Promotion Council of India (Pharmexcil)
• Indian Council of Medical Research (ICMR)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q2. Which US FDA center is chiefly responsible for the review and regulation of human prescription and over-the-counter drugs?

• Center for Biologics Evaluation and Research (CBER)
• Center for Devices and Radiological Health (CDRH)
• Center for Drug Evaluation and Research (CDER)
• Center for Food Safety and Applied Nutrition (CFSAN)

Correct Answer: Center for Drug Evaluation and Research (CDER)

Q3. What does the abbreviation eCTD mean in regulatory submissions?

• electronic Clinical Trial Database
• electronic Common Technical Document
• enhanced Chemical and Toxicology Dossier
• electronic Compliance and Testing Document

Correct Answer: electronic Common Technical Document

Q4. The 505(b)(2) regulatory pathway in the US is best described as which of the following?

• An abbreviated pathway for generic drugs with no reference to existing data
• A full NDA requiring entirely new clinical trials for safety and efficacy
• An NDA relying in part on published literature or existing data not developed by the applicant
• A biologics license application for biosimilars

Correct Answer: An NDA relying in part on published literature or existing data not developed by the applicant

Q5. What is the main purpose of a Drug Master File (DMF)?

• To register a finished formulation with the regulatory authority
• To provide confidential information about manufacturing processes, facilities, and controls to regulators
• To list all importers and distributors of an API
• To replace the need for an NDA or ANDA

Correct Answer: To provide confidential information about manufacturing processes, facilities, and controls to regulators

Q6. What is an ANDA in the US regulatory system?

• Application for approval of a new chemical entity
• Abbreviated New Drug Application for generic drug approval demonstrating bioequivalence
• Application for biologic licensing
• Application to change labeling of an approved drug

Correct Answer: Abbreviated New Drug Application for generic drug approval demonstrating bioequivalence

Q7. What does BLA stand for?

• Biologic Licensing Agreement
• Biologics License Application
• Biological Laboratory Assessment
• Bioproducts Licensing Authorization

Correct Answer: Biologics License Application

Q8. Which document historically contained specific Indian requirements for clinical trial conduct and approval?

• ICH M4 Guidance
• Schedule Y of the Drugs and Cosmetics Rules
• Good Distribution Practices (GDP) Guidelines
• International Pharmacopoeia

Correct Answer: Schedule Y of the Drugs and Cosmetics Rules

Q9. Which ICH guideline primarily addresses stability testing of new drug substances and products?

• ICH Q3A
• ICH Q1A
• ICH S6
• ICH M7

Correct Answer: ICH Q1A

Q10. What is the purpose of a Risk Evaluation and Mitigation Strategy (REMS) required by the US FDA?

• To expedite review of breakthrough drugs
• To provide a detailed manufacturing validation plan
• To ensure that benefits of a drug outweigh its serious risks through specific risk-minimization measures
• To replace post-marketing surveillance requirements

Correct Answer: To ensure that benefits of a drug outweigh its serious risks through specific risk-minimization measures

Q11. For generic drug approval in India, what key study is generally required by CDSCO to demonstrate interchangeability with the reference listed product?

• Full-scale Phase III clinical efficacy trial
• Bioequivalence study
• Only comparative stability testing
• No studies are required for any generic

Correct Answer: Bioequivalence study

Q12. How many modules are there in the Common Technical Document (CTD) structure used for regulatory submissions?

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

Correct Answer: 5 modules

Q13. Under US FDA review timelines, what is the typical goal review time for a Priority Review application?

• 3 months
• 6 months
• 9 months
• 12 months

Correct Answer: 6 months

Q14. What does a Paragraph IV certification in an ANDA filing indicate?

• The applicant will market after patent expiry without challenge
• The applicant asserts that the listed patent is invalid or will not be infringed by the generic product
• The applicant is seeking orphan drug exclusivity
• The applicant is requesting accelerated approval

Correct Answer: The applicant asserts that the listed patent is invalid or will not be infringed by the generic product

Q15. The Fast Track designation by the US FDA is intended to facilitate development and expedite review for drugs that treat what kind of conditions?

• Minor, self-limiting illnesses
• Cosmetic conditions
• Serious conditions with unmet medical need
• Conditions already well-treated by many therapies

Correct Answer: Serious conditions with unmet medical need

Q16. Which CTD module contains Chemistry, Manufacturing and Controls (CMC) quality information?

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

Correct Answer: Module 3

Q17. For approval of a biosimilar product in a regulated jurisdiction (e.g., CDSCO/USFDA approach), which types of comparative data are generally required?

• Only physicochemical characterization without clinical data
• Comparative quality, non-clinical, and clinical data demonstrating similarity to the reference biologic
• Only a full clinical program identical to the originator biologic
• No comparability studies are required for biosimilars

Correct Answer: Comparative quality, non-clinical, and clinical data demonstrating similarity to the reference biologic

Q18. The SUPAC guidance documents in the US are concerned primarily with which topic?

• Preclinical toxicology testing
• Post-approval changes such as scale-up and manufacturing process adjustments
• Labeling for over-the-counter products
• Clinical trial informed consent requirements

Correct Answer: Post-approval changes such as scale-up and manufacturing process adjustments

Q19. In pharmacovigilance terminology, what does PSUR stand for?

• Product Safety and Usage Report
• Periodic Safety Update Report
• Post-Submission Update Record
• Pharmacology and Safety Unified Report

Correct Answer: Periodic Safety Update Report

Q20. Under the Biopharmaceutics Classification System (BCS), a biowaiver (in vivo bioequivalence waiver) is most commonly considered for which class of drug substances?

• 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 (never considered)

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

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