WHO prequalification programme and regulatory requirements MCQs With Answer

This quiz set on the WHO Prequalification Programme and regulatory requirements is designed specifically for M.Pharm students studying Regulatory Aspects of Drugs & Cosmetics (MRA201T). It focuses on the practical and regulatory principles underlying WHO prequalification: dossier requirements, CTD structure, GMP inspections, batch testing, pharmacovigilance, post-listing changes, and collaborative registration mechanisms. Questions are framed to deepen understanding of how WHO standards interact with national regulatory authorities, procurement agencies, and international guidelines (ICH, PIC/S). Use these MCQs to test knowledge, prepare for exams, and reinforce real-world regulatory decision-making needed when preparing dossiers and managing product lifecycle under WHO prequalification pathways.

Q1. What is the primary purpose of the WHO Prequalification (PQ) Programme?

• To grant marketing authorisations in WHO member states
• To assess and list products that meet WHO standards of quality, safety and efficacy to facilitate procurement by UN agencies
• To provide patents and exclusive distribution rights to manufacturers
• To inspect and certify national regulatory authorities

Correct Answer: To assess and list products that meet WHO standards of quality, safety and efficacy to facilitate procurement by UN agencies

Q2. Which product categories are covered by the WHO Prequalification Programme?

• Only small-molecule oral medicines
• Medical devices exclusively
• Medicines, vaccines, biologicals and in vitro diagnostics
• Cosmetics and consumer healthcare products

Correct Answer: Medicines, vaccines, biologicals and in vitro diagnostics

Q3. What is typically the first formal step a manufacturer takes to engage with WHO Prequalification for a medicine?

• Submission of a national marketing authorisation
• Application for a GMP certificate from WHO
• Submission of an Expression of Interest (EOI) or application to the PQ programme
• Requesting WHO laboratory testing before dossier submission

Correct Answer: Submission of an Expression of Interest (EOI) or application to the PQ programme

Q4. Which dossier format is accepted and expected by WHO PQ for finished pharmaceutical products?

• STED format only
• Electronic Common Technical Document (eCTD) / CTD format (Modules 1–5)
• A simplified one-page product summary
• Only country-specific dossier formats

Correct Answer: Electronic Common Technical Document (eCTD) / CTD format (Modules 1–5)

Q5. In the CTD structure submitted to WHO PQ, which module contains detailed stability data and pharmaceutical development information?

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

Correct Answer: Module 3

Q6. Which outcome is expected following a satisfactory GMP inspection by WHO or a WHO-recognised inspector for a manufacturing site?

• Automatic national marketing authorisation in all countries
• A GMP compliance statement/certificate issued by WHO or a recognised national regulatory authority
• Removal of the facility from the WHO inspection programme
• Exemption from batch testing for 10 years

Correct Answer: A GMP compliance statement/certificate issued by WHO or a recognised national regulatory authority

Q7. What regulatory concept allows national authorities to use WHO PQ assessment reports when making their own marketing authorisation decisions?

• Regulatory duplication
• Regulatory reliance
• Regulatory isolation
• Regulatory exclusivity

Correct Answer: Regulatory reliance

Q8. What is the WHO Collaborative Registration Procedure (CRP)?

• A method to transfer manufacturing technology between companies
• A mechanism to expedite national registration by sharing WHO PQ assessment and inspection outcomes with participating national regulatory authorities
• A quality control testing programme for national labs
• An exclusive procurement agreement with UNICEF

Correct Answer: A mechanism to expedite national registration by sharing WHO PQ assessment and inspection outcomes with participating national regulatory authorities

Q9. How should a manufacturer handle major post-prequalification changes (e.g., manufacturing site change) according to WHO PQ requirements?

• Implement the change without notifying WHO and only inform buyers
• Notify WHO PQ, provide supporting data and potentially undergo reassessment or inspection
• Withdraw the product and reapply as a new product
• Only inform the national regulatory authority where the product is sold

Correct Answer: Notify WHO PQ, provide supporting data and potentially undergo reassessment or inspection

Q10. Where does WHO typically require independent quality testing of prequalified products?

• Only at the manufacturer’s in-house laboratory
• At WHO-designated or qualified independent laboratories
• At any local hospital laboratory
• Testing is not required for prequalified products

Correct Answer: At WHO-designated or qualified independent laboratories

Q11. What is the minimum stability dataset generally expected by WHO PQ for a new generic solid oral dosage form?

• One pilot batch with accelerated data only
• Data from at least three primary batches with real-time and accelerated stability data according to ICH/WHO conditions
• No stability data if the drug is well-known
• Only one year of real-time stability for all climatic zones

Correct Answer: Data from at least three primary batches with real-time and accelerated stability data according to ICH/WHO conditions

Q12. Who holds primary responsibility for pharmacovigilance and adverse event reporting for a WHO-prequalified product?

• The procurement agency that buys the product
• The marketing authorisation holder (MAH)/manufacturer
• Only the WHO Secretariat
• Private distributors handling the product

Correct Answer: The marketing authorisation holder (MAH)/manufacturer

Q13. Which international guidance documents are most commonly referenced by WHO PQ when assessing quality and GMP compliance?

• Local hospital SOPs only
• ICH guidelines, PIC/S recommendations and WHO GMP/quality guidance
• Only ISO 9001 corporate policies
• Food safety regulations

Correct Answer: ICH guidelines, PIC/S recommendations and WHO GMP/quality guidance

Q14. Which CTD module contains the overall quality summary and integrated assessments used by WHO PQ reviewers?

• Module 1
• Module 2
• Module 3
• Module 4

Correct Answer: Module 2

Q15. Compared with small-molecule medicines, what additional considerations are emphasised by WHO PQ for vaccines and biologicals?

• Cold-chain stability, potency and WHO batch release/lot release testing requirements
• No requirement for GMP inspection
• Only one clinical lot is acceptable for submission
• Shortened stability testing timelines

Correct Answer: Cold-chain stability, potency and WHO batch release/lot release testing requirements

Q16. Which of the following is NOT a function of the WHO Prequalification Programme?

• Assessing dossiers for quality, safety and efficacy
• Conducting GMP inspections and independent lab testing
• Granting national marketing authorisations in individual countries
• Facilitating procurement by UN agencies through a listing mechanism

Correct Answer: Granting national marketing authorisations in individual countries

Q17. Listing on the WHO PQ register directly facilitates procurement by which entities?

• Local retail pharmacies only
• UN procurement agencies, international donors and major procurement partners (e.g., UNICEF, Global Fund)
• Only national hospital pharmacies
• Illegal parallel traders

Correct Answer: UN procurement agencies, international donors and major procurement partners (e.g., UNICEF, Global Fund)

Q18. What is the likely regulatory consequence if a WHO GMP inspection identifies major non-conformances that are not adequately addressed?

• The site is automatically awarded additional product listings
• Request for corrective and preventive actions (CAPA), possible follow-up inspection and potential suspension or delisting of product from PQ
• No action; findings are only advisory
• Immediate permanent closure of the manufacturing company by WHO

Correct Answer: Request for corrective and preventive actions (CAPA), possible follow-up inspection and potential suspension or delisting of product from PQ

Q19. When is a bioequivalence (BE) study usually required for WHO PQ of an oral immediate-release generic product?

• Never; BE studies are not considered by WHO
• Only if the originator requests it
• BE is generally required unless a scientifically justified biowaiver is applicable
• Only for parenteral products

Correct Answer: BE is generally required unless a scientifically justified biowaiver is applicable

Q20. Does WHO Prequalification substitute for national marketing authorisation in individual countries?

• Yes — PQ automatically grants marketing authorisation in all WHO member states
• No — PQ facilitates regulatory decision-making but national regulatory authorities retain the legal authority for marketing authorisation
• Yes for vaccines but not for medicines
• No — PQ is only a procurement blacklist

Correct Answer: No — PQ facilitates regulatory decision-making but national regulatory authorities retain the legal authority for marketing authorisation

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