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Ragupathy Renganathan
Ragupathy Renganathan
Pharma Hub

MCQ Practice

Regulatory Affairs MCQs with Answers and Explanations

Regulatory Affairs MCQs reward precise recall: which module holds which document, which application route applies, which agency owns the review.

The explanations below tie each answer to the guideline it comes from.

10 free questions shown · 100 in the full test

Topics covered

  • CTD and eCTD modules
  • ANDA, NDA and DMF
  • ICH guideline families
  • Global agencies
  • Post-approval changes

10 Regulatory Affairs MCQs with answers

  1. Q1

    CTD stands for:

    • ACommon Technical Document
    • BClinical Trial Database
    • CCentral Treatment Directive
    • DCombined Test Data

    Explanation: CTD = Common Technical Document — the harmonized format for regulatory submissions.

  2. Q2

    Module 3 of CTD contains:

    • AClinical study reports
    • BNonclinical study reports
    • CQuality (CMC) information
    • DAdministrative information

    Explanation: Module 3 = Quality (Chemistry, Manufacturing & Controls).

  3. Q3

    ANDA is filed with:

    • AEMA
    • BUSFDA
    • CPMDA
    • DWHO

    Explanation: ANDA (Abbreviated New Drug Application) is filed with the USFDA for generics.

  4. Q4

    DMF stands for:

    • ADrug Master File
    • BDaily Manufacturing Form
    • CDocument Master Folder
    • DDrug Marketing Format

    Explanation: DMF = Drug Master File submitted to regulatory authorities (e.g., USFDA Type II for APIs).

  5. Q5

    ICH Q1A covers:

    • AStability testing
    • BImpurities
    • CValidation
    • DQuality systems

    Explanation: ICH Q1A(R2) covers Stability Testing of New Drug Substances and Products.

  6. Q6

    510(k) submission is used for:

    • AGeneric drugs
    • BMedical devices
    • CBiologics
    • DVaccines

    Explanation: 510(k) is a premarket submission for medical devices to USFDA.

  7. Q7

    EMA regulates pharmaceuticals in:

    • AUSA
    • BIndia
    • CEuropean Union
    • DJapan

    Explanation: European Medicines Agency (EMA) regulates medicines in the EU.

  8. Q8

    CDSCO is the regulatory body of:

    • AIndia
    • BUSA
    • CBrazil
    • DUK

    Explanation: Central Drugs Standard Control Organisation (CDSCO) is India's national regulator.

  9. Q9

    Orange Book lists:

    • AApproved drug products with therapeutic equivalence
    • BBanned substances
    • CExcipients
    • DReference standards

    Explanation: FDA's Orange Book lists approved drugs and their therapeutic equivalence ratings.

  10. Q10

    PIL stands for:

    • APatient Information Leaflet
    • BProduct Internal List
    • CPublic Inspection Log
    • DProcess Improvement List

    Explanation: PIL = Patient Information Leaflet supplied with medicinal products.

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