Practice Test Geeks(RAC) Regulatory Affairs Certification Practice Test
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Regulatory Frameworks Flashcards

7 cards from real RAC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

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  1. Under 21 CFR Part 312, what is the maximum duration of a Phase 1 clinical investigation that can be conducted under an IND before a Phase 2 protocol must be submitted?

    Answer: There is no specific time limit; Phase 1 can continue as long as needed

    The IND regulations do not prescribe a maximum duration for Phase 1; sponsors advance phases based on scientific data and safety findings.

  2. The European Medicines Agency's (EMA) centralized procedure results in a marketing authorization that is valid in how many countries?

    Answer: 30 countries (27 EU + 3 EEA)

    EMA centralized procedure approvals are valid in all 27 EU member states plus 3 EEA countries (Iceland, Liechtenstein, Norway).

  3. Which regulatory framework governs the approval of biosimilar products in the United States?

    Answer: Biologics Price Competition and Innovation Act (BPCIA)

    The BPCIA, enacted in 2010 as part of the Affordable Care Act, established the abbreviated licensure pathway for biosimilar biological products.

  4. A sponsor submits an NDA for a new drug. FDA issues a Complete Response Letter (CRL). What does this signify?

    Answer: FDA has determined the application is not approvable in its current form

    A CRL indicates the application cannot be approved in its present form and describes deficiencies the sponsor must address before resubmission.

  5. Under ICH E6(R2) Good Clinical Practice, which party holds primary responsibility for the overall conduct and management of a clinical trial?

    Answer: The sponsor

    ICH E6(R2) places primary responsibility for the conduct, management, and oversight of a clinical trial with the sponsor.

  6. Which section of the Code of Federal Regulations covers Current Good Manufacturing Practice (cGMP) for finished pharmaceuticals?

    Answer: 21 CFR Part 210 and Part 211

    21 CFR Parts 210 and 211 together establish the cGMP regulations for the manufacture, processing, packing, and holding of finished pharmaceutical products.

  7. Japan's Pharmaceutical and Medical Device Act (PMD Act) replaced which predecessor law?

    Answer: Japanese Pharmaceutical Affairs Law (PAL)

    The PMD Act (enacted 2014) replaced the Pharmaceutical Affairs Law (PAL), expanding scope to include medical devices and regenerative medicine products.