Pharmacovigilance services in UK

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulatory and pharmacovigilance operations in the UK. Patient safety is the core of all pharmacovigilance activities where timely detection and management of ADRs is imperative in order to implement effective risk mitigation/minimization 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 (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

As a leading global contender, DDReg understands the significance of patient safety right from spontaneous to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in UK that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.