Pharmacovigilance services in UK

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in the UK, explore DDReg’s pharmacovigilance services in UK to ensure drug safety and regulatory compliance. From adverse drug reaction reporting to compliance with MHRA pharmacovigilance regulations, the right PV partner shapes everything: signal detection, risk management planning, safety reporting, and successful market authorisation.

Expert Pharmacovigilance Services for the UK Market

The Medicines and Healthcare products Regulatory Agency (MHRA) is the national authority responsible for regulatory and pharmacovigilance operations in the UK. Patient safety is at the core of all pharmacovigilance solutions, where timely detection and management of adverse drug reactions (ADRs) is imperative in order to implement effective risk mitigation/minimisation strategies. For medicines which are authorised nationally in the UK, a Marketing Authorisation Holder (MAH) must submit the necessary pharmacovigilance data to the MHRA such as UK and non-UK Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and Post-Authorisation Safety Studies (PASS) protocols and final study reports.

The MAH shall have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance (UK QPPV). If the UK QPPV is not based in the United Kingdom, a National Contact Person for Pharmacovigilance (NCPP) must be based in the United Kingdom for any immediate enquiries. MHRA promotes safe medication use through prevention, identification, analysis, management and documentation of adverse effects and drug-related problems.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Case Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug Dictionary (WHO DD) and MedDRA
  • Quality Check, Medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR monitoring & tracking sheets
  • Reconciliation process with customers
• + Risk Management Plan (RMP)
  • Drafting, reviewing, and maintaining RMPs and REMS while providing support through submission methods
  • Preparing customised procedures to classify safety risks and deliver tailored risk management strategies
  • Assessment of potential risks and missing information, preparing reports that recommend risk minimisation methods
  • Implementation of supplementary measures, including Post-Authorisation Safety Studies (PASS), such as developing academic materials, observational examinations, and targeted follow-up questionnaires
  • Effectively convey risks through labelling means such as Summary of Product Characteristics (SmPC) and patient information leaflet (PIL)
• + Aggregate Reports
  • Periodic Safety Update Report (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management in Pharmacovigilance in UK
  • Identification of new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, literature, aggregate reports as well as regulatory agency website monitoring
  • Use of a variety of in-house tools and databases for signal detection and tracking safety signal monitoring
  • Reviews of safety signals for ICSRs, aggregate reports and recommendations by the Pharmacovigilance Risk Assessment Committee (PRAC) or MHRA equivalent
  • Performs label update analysis
  • Provide recommendations from signal assessments which include risk minimisation approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports
• + UK QPPV / National Contact Person for Pharmacovigilance (NCPP)
  • Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etc
  • Review & sign-off of aggregate reports, signal reports and RMPs
  • Retainer services for QPPV services and deputy
  • Local Safety Responsible functions
  • Monthly reconciliation
  • Medical review of signal detection; signal surveillance meetings (Quarterly)
  • Monthly communication report / provision of compliance metrics
• + PV Quality Management System Oversight & PV Audit & Compliance
  • Review compliance audit to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs and work instructions
  • Optimise well-constructed audit plans as well as mock audits to prepare customer organisations for PV inspections conducted by the competent authority
  • Conduct regular gap assessments of PV staff at site location
  • Provide organisational training on safety audits and inspections