UK regulatory affairs Flashcards
What is the difference between Global and Local Regulatory Affairs?
Global RA: Defines overall strategy for multiple markets, coordinates EU & US approvals.
Local RA: Implements strategy at a national level, liaises with local health authorities (e.g., MHRA in the UK).
Who are the key stakeholders in Local Regulatory Affairs?
Labelling Teams, CMC, Clinical Trials, Commercial & Brand Teams, Supply Chain Management, Safety & Pharmacovigilance Teams.
Why is the UK an important regulatory market?
One of the top 10 global pharmaceutical markets, serves as a reference market for international approvals.
How has Brexit affected UK drug regulation?
The UK is developing independent regulatory processes, separate from the EMA.
What does the MHRA regulate?
Medicines & Vaccines, Medical Devices, Traditional & Herbal Medicines.
How did the Thalidomide disaster impact UK regulations?
Led to the creation of the Committee on the Safety of Drugs, ensuring independent drug testing before approval.
What is a Marketing Authorisation (MA)?
A legal licence allowing a medicine to be sold in the UK, demonstrating quality, safety, and efficacy.
What are the key modules in an MAA?
Module 1: UK-specific details.
Module 2: Overview of studies.
Module 3: CMC (Quality).
Module 4: Non-clinical safety.
Module 5: Clinical trial data.
What are the key stages in the MHRA review process?
Phase I (80 days), RFI (60 days), Phase II (70 days), Approval & Licence Granted.
What are the different types of MA variations?
Type IA (Administrative, 30 days),
Type IA(IN) (Immediate, 2 weeks),
Type IB (Minor, 30-90 days),
Type II (Major, 90-120 days).
How do MA variations affect patients?
SmPC (for HCPs), PIL (for patients), Packaging updates (supply chain continuity).
What are the two key post-market safety reports?
DSUR: Annual clinical trial safety report.
PBRER: Every 6 months for 2 years, then every 3 years (real-world safety data).
What are the key UK clinical trial applications?
CTA: Submitted to MHRA & Ethics Committees.
SA: Changes affecting safety, validity, or trial management.
EOTN: Required within 90 days of study completion (or 15 days if terminated early).
What are the five UK fast-track regulatory pathways?
- ILAP: Accelerates access to life-threatening medicines.
- Rolling Review: Allows incremental submission of MAA modules.
- Project Orbis: Oncology fast-track approvals.
- ACCESS Consortium: Regulatory collaboration with UK, Australia, Canada, Switzerland, Singapore.
- Orphan Drug Designation (ODD): 10 years of market exclusivity for rare diseases.
What is the goal of Project Orbis?
Fast-track oncology drug approvals across UK, US, Australia, Canada, Singapore, Brazil, Switzerland.
What is the ACCESS Consortium?
Regulatory work-sharing group for New Active Substances (NAS), Biosimilars, and Generics across UK, Australia, Canada, Switzerland, Singapore.
What benefits does ODD provide?
10 years of market exclusivity (+2 years for paediatric plans).
What key differences exist in UK regulation post-Brexit?
Pre-Brexit: UK followed EMA procedures.
Post-Brexit: MHRA has independent processes & converted EU licences into National UK Licences (“Grandfathering”).
What new licensing procedures exist post-Brexit?
- National Procedures (UK-only MAA).
- International Recognition Procedure (2024): UK accepts approvals from FDA, EMA, Japan, Canada, etc.
