RAC Regulatory Frameworks 2 — Questions and Answers
Question 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?
- There is no specific time limit; Phase 1 can continue as long as needed (Correct answer)
- 6 months from IND effective date
- 1 year from IND effective date
- Phase 2 protocol must be submitted before Phase 1 begins
Correct 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.
Question 2: The European Medicines Agency's (EMA) centralized procedure results in a marketing authorization that is valid in how many countries?
- 27 EU member states only
- 30 countries (27 EU + 3 EEA) (Correct answer)
- 32 countries including UK post-Brexit
- All Council of Europe member states
Correct 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).
Question 3: Which regulatory framework governs the approval of biosimilar products in the United States?
- Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act)
- Biologics Price Competition and Innovation Act (BPCIA) (Correct answer)
- 21st Century Cures Act
- Food and Drug Administration Safety and Innovation Act (FDASIA)
Correct 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.
Question 4: A sponsor submits an NDA for a new drug. FDA issues a Complete Response Letter (CRL). What does this signify?
- The NDA has been approved with post-marketing commitments
- FDA has determined the application is not approvable in its current form (Correct answer)
- The drug has been denied approval permanently
- FDA requires a panel hearing before making a decision
Correct 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.
Question 5: Under ICH E6(R2) Good Clinical Practice, which party holds primary responsibility for the overall conduct and management of a clinical trial?
- The Institutional Review Board/Ethics Committee
- The principal investigator at each site
- The sponsor (Correct answer)
- The contract research organization (CRO) when one is engaged
Correct answer: The sponsor
ICH E6(R2) places primary responsibility for the conduct, management, and oversight of a clinical trial with the sponsor.
Question 6: Which section of the Code of Federal Regulations covers Current Good Manufacturing Practice (cGMP) for finished pharmaceuticals?
- 21 CFR Part 11
- 21 CFR Part 210 and Part 211 (Correct answer)
- 21 CFR Part 314
- 21 CFR Part 820
Correct 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.
Question 7: Japan's Pharmaceutical and Medical Device Act (PMD Act) replaced which predecessor law?
- Japanese Pharmaceutical Affairs Law (PAL) (Correct answer)
- Pharmaceutical Products Quality Law
- Medical Device Safety Assurance Act
- Drug and Cosmetics Control Law
Correct 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.
RAC Regulatory Frameworks 2
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?