Regulatory Affairs interview questions (with answers)
20 original interview questions with answers for pharma regulatory affairs freshers and candidates with up to 3 years of experience: CTD modules, ANDA, DMF, CDSCO approvals, ICH Q-series and variations. Tap an option to check your answer, or open "Show answer".
1. Which module of the Common Technical Document (CTD) is region-specific?
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Answer: B — Module 1 holds regional administrative and prescribing information, such as application forms and the proposed label, and each authority defines its content. Modules 2 to 5 are common to all ICH regions.
2. What kind of information is filed in CTD Module 3?
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Answer: C — Module 3 carries the quality data on drug substance and drug product, presented in the structure set out in ICH M4Q. Nonclinical and clinical reports go to Modules 4 and 5.
3. What does CTD Module 2 contain?
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Answer: A — Module 2 holds the high-level summaries and overviews of the quality, nonclinical and clinical modules. Detailed data stays in Modules 3 to 5.
4. Where are clinical study reports (including bioequivalence study reports) placed in the CTD?
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Answer: D — Module 5 is the clinical module, so clinical and bioequivalence study reports are filed there. Module 4 is for nonclinical (animal and in vitro safety) studies.
5. What is the purpose of the eCTD standard maintained under ICH M8?
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Answer: B — The eCTD is the agreed electronic format for submissions, built on the modular CTD layout, and it also supports maintaining the file through the product's life. Regional Module 1 content is specified by each region.
6. What does an applicant for an ANDA (generic application) generally have to show in the US?
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Answer: C — The ANDA route relies on the earlier finding of safety and effectiveness for the reference drug, so bioequivalence replaces new clinical trials. Inactive ingredients may differ, subject to the applicable requirements.
7. Which type of US Drug Master File (DMF) is normally used for a drug substance, its intermediates or the materials used to make them?
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Answer: A — Type II covers drug substance, drug substance intermediate and materials used in their preparation, or drug product. Type III is packaging material, Type IV is excipients and Type V is FDA-accepted reference information.
8. Does FDA review and approve a DMF on its own?
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Answer: D — 21 CFR 314.420 states that FDA ordinarily neither independently reviews nor approves or disapproves DMFs. The information is reviewed as part of the IND or application that incorporates it.
9. What lets an applicant rely on another company's DMF?
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Answer: B — An application can incorporate DMF information only if the holder authorises it in writing, and the DMF keeps a list of those authorised. This lets the holder protect confidential process details while the applicant relies on them.
10. Under the US system, which DMF type would a supplier of an excipient or colourant use?
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Answer: C — Type IV is for excipients, colorants, flavors, essences or materials used to prepare them. Packaging material goes to Type III.
11. In India, what role do Subject Expert Committees (SECs) play in the approval of new drugs?
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Answer: A — Rule 100 of the New Drugs and Clinical Trials Rules, 2019 lets the Central Licencing Authority constitute expert committees to evaluate scientific and technical matters, and CDSCO's Subject Expert Committees advise it on new drug and clinical trial applications. The committees do not issue licences; manufacturing licences are granted under the Drugs and Cosmetics Rules, 1945, mainly by State Licensing Authorities.
12. Under the New Drugs and Clinical Trials Rules, 2019, in which form does a person apply to the Central Licencing Authority for permission to import a new drug for sale or distribution?
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Answer: D — Rule 75 requires the import application in Form CT-18, and the permission is granted in Form CT-19 (active pharmaceutical ingredient) or Form CT-20 (formulation). Manufacture for sale is applied for in Form CT-21 and permitted in Form CT-22 or CT-23, while Form CT-10 is for manufacturing a new drug for clinical trials, BA/BE studies or test and analysis.
13. Under ICH Q3A(R2), what is the reporting threshold for impurities in a new drug substance with a maximum daily dose of up to 2 g per day?
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Answer: B — The reporting threshold for a maximum daily dose of 2 g/day or less is 0.05%. Identification and qualification thresholds are higher (0.10% and 0.15%, or a daily intake limit, whichever is lower).
14. What is the difference in scope between ICH Q3A and ICH Q3B?
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Answer: D — Q3A addresses impurities from the synthesis of the drug substance. Q3B addresses degradation products and reaction products in the finished product. Residual solvents are covered by Q3C.
15. What does ICH Q8(R2) say about a design space?
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Answer: C — Q8(R2) says an applicant may choose an empirical or a more systematic approach to development; a design space is proposed by the applicant and then assessed by the authority. A combination of proven acceptable ranges is not itself a design space, and specifications are still needed.
16. Which ICH guideline describes a pharmaceutical quality system that includes change management?
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Answer: A — Q10 is the model for a pharmaceutical quality system across the product lifecycle and includes change management as a key element. Q9 supplies the risk-management tools used in it.
17. In ICH Q12, what are "Established Conditions" (ECs)?
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Answer: D — ECs define what must be reported to the authority if changed after approval. Q12 also introduces the Product Lifecycle Management document and Post-Approval Change Management Protocols.
18. In the EU variations system, what is a Type II variation?
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Answer: B — Under Regulation (EC) No 1234/2008, Type IA and IB are minor variations, and Type II are major variations needing prior approval. Type IB is also the default when a change's category is undetermined.
19. Under 21 CFR 314.70, a formulation change with a substantial potential to adversely affect product quality normally needs which type of filing?
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Answer: C — Changes with substantial potential for adverse effect are major changes and need a prior approval supplement before product made with the change is distributed. Moderate changes use a CBE-30 and minimal changes go in the annual report.
20. Under 21 CFR 314.70(d), where are changes with minimal potential for adverse effect reported to FDA?
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Answer: A — Minor changes are documented in the annual report under 21 CFR 314.81(b)(2), but the holder must still assess the effects of the change first. This is why regulatory affairs should review every change control, not only the major ones.