Pharmacovigilance in the UK

Our UK team designs, implements, and manages pharmacovigilance systems for medicinal products across their full lifecycle. We operate within the UK regulatory framework, ensuring compliance with MHRA requirements while maintaining alignment with EU and international pharmacovigilance standards.

We support marketing authorisation holders (MAHs) and clinical sponsors with robust, inspection-ready pharmacovigilance systems, covering safety data collection, evaluation, reporting, and ongoing benefit–risk management.

UK Regulatory Landscape

The UK pharmacovigilance framework is governed by retained EU legislation alongside UK-specific regulatory processes and MHRA guidance. While closely aligned with EU Good Pharmacovigilance Practice (GVP), the UK now operates as an independent regulatory environment with its own submission systems, oversight, and inspection approach.

Legal Framework

Pharmacovigilance obligations are defined under the Human Medicines Regulations 2012 (SI 2012/1916), requiring MAHs to maintain a compliant pharmacovigilance system, monitor product safety, and ensure timely reporting of adverse reactions. The MHRA acts as the competent authority responsible for pharmacovigilance oversight, inspections, and safety evaluation.

UK Pharmacovigilance System

Post-Brexit, companies must operate UK-specific pharmacovigilance processes alongside EU systems where applicable. This includes ICSR submission to MHRA systems, maintenance of a UK PSMF or addendum, appointment of a UK QPPV or National Contact Person, and compliance with UK GVP requirements.

What We Handle Locally

Our UK team delivers pharmacovigilance services across post-marketing and clinical development within the UK regulatory framework. For the underlying methodology, see the central page.

  • Pharmacovigilance system set-up and governance. We establish and maintain compliant pharmacovigilance systems, including PSMF development, SOP creation, safety governance structures, and inspection readiness.
  • Case processing and reporting. We manage ICSRs, including collection, triage, medical review, submission to MHRA, and follow-up. Medical Information systems are integrated to ensure adverse events and product quality complaints are captured and transferred into pharmacovigilance workflows.
  • Aggregate reporting and benefit–risk evaluation. We provide end-to-end support for PSURs/PBRERs, DSURs, and other aggregate reports, ensuring consistent data, robust analysis, and regulatory alignment.
  • Signal detection and risk management. We conduct signal detection and evaluation, develop and maintain Risk Management Plans (RMPs), and ensure alignment with regulatory expectations and product information.
  • Clinical trial pharmacovigilance. We support investigational products through SUSAR reporting, DSUR preparation, safety system design, and CRO oversight, ensuring compliance with UK clinical trial regulations and ICH standards.
  • Literature and safety monitoring. We perform structured monitoring of scientific literature and other safety data sources, integrating findings into ongoing safety evaluation.
  • Training and compliance. We deliver GVP-aligned training programmes, inspection readiness support, and role-based learning tailored to pharmacovigilance responsibilities.

Our UK Team

Pharmacovigilance in the UK is delivered by our UK team, comprising and regulatory professionals with experience across aggregate reporting, clinical safety, risk management, and MHRA interactions.

UK-Specific Considerations

  • ICSR reporting. Submission to MHRA systems is required, with potential dual reporting for UK and EU authorisations.
  • Aggregate reporting. PSURs/PBRERs and DSURs must align with ICH and GVP requirements and demonstrate consistent safety data.
  • Risk management. RMPs must be maintained in a UK-compliant format and aligned with evolving safety data.
  • Clinical trials. Sponsors must comply with UK clinical trial regulations, including SUSAR reporting and DSUR submissions.
  • Medical Information. Systems must capture and forward adverse events into pharmacovigilance workflows.
  • Training and governance. Ongoing training and compliance systems are required to maintain inspection readiness.

Key UK Regulations and Guidance

Setting up or managing Pharmacovigilance in the UK?

Tell us about your product, safety profile, and current pharmacovigilance setup, and we will outline how we can support compliant UK PV systems and ongoing safety obligations.

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Frequently Asked Questions (FAQ)

What pharmacovigilance activities are required in the UK?

MAHs must maintain pharmacovigilance systems, process and report ICSRs, perform signal detection, and prepare aggregate reports such as PSURs and DSURs.

How does clinical trial pharmacovigilance differ from post-marketing PV?

Clinical trial PV focuses on investigational products and includes SUSAR reporting and DSUR preparation, while post-marketing PV monitors authorised products through structured safety systems.

What is the role of Risk Management Plans?

RMPs define safety concerns, pharmacovigilance activities, and risk minimisation measures throughout the product lifecycle.

How does Medical Information support pharmacovigilance?

Medical Information functions act as a key intake channel for adverse events and product quality complaints, ensuring they are captured and transferred into pharmacovigilance systems.