Regulatory requirements of MHRA MCQs With Answer

Regulatory requirements of MHRA MCQs With Answer helps M. Pharm students master the UK regulatory framework governed by the Medicines and Healthcare products Regulatory Agency (MHRA). This quiz focuses on essential requirements across the product lifecycle: clinical trial authorisations, dossier formats, GMP/GDP expectations, Qualified Person (QP) responsibilities, pharmacovigilance (QPPV, PSMF, PSUR), post-approval variations, and device registration. It also touches on UK-specific pathways post-Brexit, such as ILAP, national submission routes, and UK-specific vigilance and labelling considerations, including differences for Great Britain and Northern Ireland. Each question is designed to test applied understanding for regulatory practice, aligning with MPH 104T objectives. Use these MCQs to assess readiness for real-world submissions, inspections, and compliance audits.

Q1. Which primary legislation governs the authorisation, manufacture, distribution, and pharmacovigilance of human medicines in the UK?

• Directive 2001/83/EC (as applied directly)
• US Federal Food, Drug, and Cosmetic Act
• Human Medicines Regulations 2012 (SI 2012/1916)
• Medicines Act 1968 (standalone, without subsequent consolidation)

Correct Answer: Human Medicines Regulations 2012 (SI 2012/1916)

Q2. For initiating a clinical trial of an investigational medicinal product (IMP) in the UK, what authorisation is required from the MHRA?

• Marketing Authorisation (MA)
• Clinical Trial Authorisation (CTA)
• Investigational New Drug (IND)
• Certificate of Suitability (CEP)

Correct Answer: Clinical Trial Authorisation (CTA)

Q3. Which document provides the key quality, non-clinical and clinical information on an IMP to support a CTA application?

• Investigator’s Brochure (IB) only
• Common Technical Document (CTD) Module 1 only
• Investigational Medicinal Product Dossier (IMPD)
• Risk Evaluation and Mitigation Strategy (REMS)

Correct Answer: Investigational Medicinal Product Dossier (IMPD)

Q4. Under MHRA requirements, what is the expedited reporting timeline for a fatal or life-threatening SUSAR in a UK clinical trial?

• Within 24 hours of awareness, no follow-up required
• Within 7 days with an additional 8 days for complete follow-up information
• Within 10 days, followed by 10 days for follow-up
• Within 15 days with no follow-up requirement

Correct Answer: Within 7 days with an additional 8 days for complete follow-up information

Q5. What dossier format does the MHRA require for national Marketing Authorisation Applications (MAAs) for human medicines?

• Paper-only dossier with regional structure
• Electronic Common Technical Document (eCTD)
• Non-CTD electronic submission (NeeS)
• Company-specific proprietary template

Correct Answer: Electronic Common Technical Document (eCTD)

Q6. Which of the following best describes the Qualified Person’s (QP) responsibility under UK GMP?

• Approving marketing artwork and promotional claims
• Certifying each batch before release for sale or for clinical trial use
• Negotiating pricing and reimbursement
• Approving investigator site contracts

Correct Answer: Certifying each batch before release for sale or for clinical trial use

Q7. What type of licence and responsible function are required to conduct wholesale distribution of human medicines in the UK?

• Manufacturing/Importation Authorisation (MIA) with Qualified Person (QP)
• Wholesale Dealer’s Authorisation [WDA(H)] with Responsible Person (RP)
• Retail Pharmacy Licence with Superintendent Pharmacist
• Clinical Trial Authorisation with Principal Investigator (PI)

Correct Answer: Wholesale Dealer’s Authorisation [WDA(H)] with Responsible Person (RP)

Q8. With respect to UK pharmacovigilance, which statement is correct for products authorised in the UK?

• A PSMF is optional if a EU QPPV is appointed
• A UK Pharmacovigilance System Master File (PSMF) must be available and accessible in the UK
• PSURs are never required once a product is more than 10 years on the market
• Only non-serious ICSRs are reportable to the MHRA

Correct Answer: A UK Pharmacovigilance System Master File (PSMF) must be available and accessible in the UK

Q9. Which best reflects MHRA expectations regarding the person responsible for pharmacovigilance for UK licences?

• No QPPV is required if there is a medical director in the UK
• A QPPV must be available 24/7; if not UK-based, a UK National Contact Person for PV must support per MHRA guidance
• The QPPV may be based anywhere globally with no UK contact
• Only a part-time consultant is required with no formal designation

Correct Answer: A QPPV must be available 24/7; if not UK-based, a UK National Contact Person for PV must support per MHRA guidance

Q10. What is the Yellow Card Scheme in the context of MHRA-regulated products?

• A controlled drug prescription monitoring program
• The UK’s national system for reporting suspected adverse events and device incidents
• A GMP certificate issued to compliant manufacturers
• A batch release certificate issued by the Official Medicines Control Laboratory

Correct Answer: The UK’s national system for reporting suspected adverse events and device incidents

Q11. Which variation category generally requires prior approval by the MHRA before implementation due to major impact on quality, safety, or efficacy?

• Type IA
• Type IB
• Type II
• Line extension

Correct Answer: Type II

Q12. For periodic safety reporting post-authorisation, which scheduling principle does the MHRA generally follow?

• Company-defined ad hoc schedules only
• EU Reference Dates (EURD) list for PSUR/PBRER cycles where applicable
• No periodic safety reports are accepted by the MHRA
• Annual PSURs for the entire product lifetime

Correct Answer: EU Reference Dates (EURD) list for PSUR/PBRER cycles where applicable

Q13. Which UK licence is specifically required for the manufacture and/or importation of investigational medicinal products?

• MIA(IMP)
• WDA(H)
• Manufacturing Authorisation for Active Substances (MSA)
• Clinical Establishment Licence

Correct Answer: MIA(IMP)

Q14. Which UK region continues to align with certain EU medicines rules, including recognition of certain EU authorisations, under the current framework?

• England
• Scotland
• Wales
• Northern Ireland

Correct Answer: Northern Ireland

Q15. Which statement best describes the UK Combined Review process for clinical trials via IRAS?

• It provides ethics approval only; MHRA approval is separate and sequential
• It provides a coordinated, parallel review yielding both MHRA regulatory approval and REC opinion
• It is used only for device studies, not drug trials
• It replaces the need for site-level R&D approvals

Correct Answer: It provides a coordinated, parallel review yielding both MHRA regulatory approval and REC opinion

Q16. Which of the following best describes MHRA’s expectation for post-authorisation safety communications to healthcare professionals about an important new risk or risk minimisation?

• Publication only on the company website
• Direct Healthcare Professional Communication (DHPC), agreed with MHRA
• Press release without prior authority review
• Investigator’s Brochure update only

Correct Answer: Direct Healthcare Professional Communication (DHPC), agreed with MHRA

Q17. Which system/route is appropriate for the electronic submission of individual case safety reports (ICSRs) to the MHRA for marketed products?

• US FDA FAERS webtrader
• MHRA ICSR Submissions (Gateway/API) compliant with ICH E2B(R3)
• Paper MedWatch forms by post
• Direct REC email submission

Correct Answer: MHRA ICSR Submissions (Gateway/API) compliant with ICH E2B(R3)

Q18. In the UK, what document describing identified risks, potential risks, and proposed risk minimisation is required as part of MA applications and lifecycle management?

• Risk Management Plan (RMP)
• Certificate of Analysis (CoA)
• Standard Operating Procedure (SOP)
• Clinical Study Report (CSR)

Correct Answer: Risk Management Plan (RMP)

Q19. Which of the following is not an MHRA-conducted GxP inspection type relevant to medicines regulation?

• Good Manufacturing Practice (GMP)
• Good Distribution Practice (GDP)
• Good Clinical Practice (GCP)
• HIPAA compliance inspections

Correct Answer: HIPAA compliance inspections

Q20. Which UK initiative is designed to accelerate access to innovative medicines, offering tools such as a Target Development Profile and the option of rolling review?

• PRIME (EMA)
• Project Orbis (FDA/International)
• Innovative Licensing and Access Pathway (ILAP)
• Mutual Recognition Procedure (MRP)

Correct Answer: Innovative Licensing and Access Pathway (ILAP)

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