Pharmacovigilance in United Kingdom
How is it with the drug safety system in British Isles? Read our guide to get a clear picture.
And of course, if you feel you need a local consultant, we’re here for you.
Current status of our United Kingdom’s pharmacovigilance services:
LCPPV / QPPV in United Kingdom
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in United Kingdom?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The primary authority on pharmacovigilance in the United Kingdom is the Medicines and Healthcare products Regulatory Agency (MHRA), which is headquartered in London and is responsible for ensuring the safety and efficacy of medicines throughout the UK.
Alongside with MHRA these six regional Yellow Card centres play an important supporting role in monitoring medicine safety at a local level (making ADR reporting more accessible and responsive to local needs).
Interesting website sections related to pharmacovigilance
DRUG SAFETY UPDATE
Page dedicated to individual notices regarding drug safety, usually published irregularly, such as risks of drug interactions. From the peridocial ones we can mention Letters and medicine recalls sent to healthcare professionals, which is a summary. There is also a possibility to subscribe to the their Drug Safety Newsletter.
GUIDANCE ON PHARMACOVIGILANCE PROCEDURES
This page contains the basic information regarding pharmavigilance, in the HTML document you’ll find all neccessity information on MHRA’s general approach, Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs) and more. There are also two webinars called “Pharmacovigilance requirements for UK authorised products”.
MEDICINE: LICENSING & APPLICATIONS
Variety of guidances is listed on this page regarding many areas such as New applications, Payment, Fees, Packaging, Labelling and mroe. There are also some collections, for example Marketing authorisations granted by years.
RESEARCH & STATISTICS
This section includes several dozens of statistics, you can filter them by already published or upcoming. We can mention Annual review of good clinical practice referrals, Pharmacovigilance inspection metrics, 2009 to present or Quarterly reports on the import of unlicensed medicines.
NEWS AND COMMUNICATIONS
This is the section, where you should go, when you want to know what new medicine or vaccine MHRA approves, want to read some reminders from HMRA or you can read more about MedSafetyWeak 2024, which purpose is to raise awareness about the importance of reporting suspected side effects, and much more.
YELLOW CARD REPORTING SITE
While this site is mainly for reporting ADRs, there are also two other sections we can recommend. First one is “Case Studies”, these studies highlight how Yellow Card reports have played a crucial role in enhancing patient safety. Second one is “Latest News”, where some guidances and field safety notices can be found.
BLOG MEDREGS
The official blog of MHRA offers valuable insights into the latest regulatory developments and practices surrounding medicines. There are many commentaries on important topics, which are categotized on the right side when you scroll down a bit.
MHRA INSPECTORATE BLOG
This blog is a valuable resource for those involved in the regulation of medicines, offering insights into the latest updates and guidelines directly from inspectors, from January 2024 there is a special section regarding Good Pharmacovigilance Practice.
Other important institutions & industry groups
DEPARTMENT OF HEALTH AND SOCIAL CARE (DHSC)
This is the main governmental body responsible for public health, social care, and the National Health Service (NHS) in England. It provides leadership and sets policies for health and social care.
When visiting Departments’s website, you’ll notice some publication on the main page and it is good to keep an eye on it, because from time to time there are interesting articles, such as ongoing national conversation about NHS (National Health System). We also recommend to visit “Guidance and regulation” section, where many important documents can be found, for example Guidance: Good manufacturing practice and good distribution practice. Another interesting section are Statistics, including Monthly statistics for adult social care (England).
DHSC’s website: https://www.gov.uk/government/organisations/department-of-health-and-social-care
UK HEALTH SECURITY AGENCY (UKHSA)
Established in 2021, the UKHSA focuses on public health protection and emergency preparedness, including responses to infectious disease outbreaks and health threats.
UKHSA’s website are practically identical to the Department’s one, so it should be really use for you to go all content there. For starters, once again on the website you’ll find some publications. In their “Guidance and regulation” section, you’ll find many important documents, this time on topics like how to report notifiable diseases and what are they. “Research and statistics” include documents on mortality surveillance, annual data on HIV and more, there’s also a special website dedicated to research iself.
UKHSA’s website: https://www.gov.uk/government/organisations/uk-health-security-agency
BIOINDUSTRY ASSOCIATION (BIA)
Represents the UK’s bioscience sector, including biotechnology companies involved in drug development and medical technologies. The BIA advocates for policies that foster innovation and growth in the life sciences industry.
Their website does not provide much interesting content, though it’s still good to know about this association. On their website you can subscribe to the Newscast, in case you’d like to receive information from the biotech and life sciences industry, or you can vbisit the blogs section, where are mostly CEO updates, which is basically a summary from CEO on past events, updates and more.
Association’s website: https://www.bioindustry.org/
ASSOCIATION OF THE BRITISH PHARMACEUTICAL INDUSTRY (ABPI)
Represents the interests of innovative pharmaceutical companies in the UK, advocating for policies that support research, development, and patient access to medicines. The ABPI plays a crucial role in promoting collaboration between the pharmaceutical industry and the NHS.
On this website we can find many interesting publications, such as these guidance notes on how to handle safety information and product complaints that arise from digital activities are worth mentioning or Pharmaceutical Reputation Index, which shares the main highlights and key insights gathered from a year of research involving the public, healthcare professionals, and Members of Parliament, revealing their true thoughts and feelings about pharmaceutical companies in the UK. You can also see pharmaceutical industry statistics here.
ABPI’s website: https://www.abpi.org.uk/
Some of the most important laws
Basic legislation
The Human Medicines Regulations 2012
This foundational legislation requires the licensing authority (MHRA) to operate a pharmacovigilance system for medicinal products sold in Great Britain.
The Medicines and Medical Devices Act 2021
This act provides a framework for regulating medicines and medical devices, including provisions for pharmacovigilance.
Guidelines
Good Pharmacovigilance Practice (GVP) Modules
Although the UK has exited the EU, the principles of the EU pharmacovigilance framework continue to influence UK regulations.
Local pharmacovigilance specifics
Is LCPPV needed or is QPPV enough?
LCPPV is not needed, QPPV is enough. Holders of UK marketing authorizations must have an appropriately qualified QPPV who resides and operates either in the UK or the EU/EEA. If the QPPV resides and operates in the EU/EEA, the MAH must nominate a national contact person for pharmacovigilance who resides and operates in the UK and reports to the QPPV, further information can be found in this guidance.
If you need a translation of those instructions or more information about LCPPV requirements in Europe in general, just check our free comprehensive guide available here.
How can be adverse events reported in United Kingdom?
In the UK, suspected adverse drug reactions (ADRs) can be reported through the Yellow Card Scheme, submit a report electronically via the Yellow Card website. Reporting can be also done via Yellow Card official app or telephone.
Local medical journals to screen
Here are few examples of United Kingdom’s local literature that medical authorization holders should monitor:
DRUG SAFETY
This journal focuses on the safety of drugs and the impact of pharmacovigilance practices, providing comprehensive research articles and reviews that explore adverse drug reactions and risk management strategies.
It is a key resource for professionals seeking to stay updated on the latest findings in drug safety and efficacy.
ISSN: 1179-1942
BRITISH JOURNAL OF CLINICAL PHARAMCOLOGY
This journal publishes original research and reviews on all aspects of clinical pharmacology, including pharmacovigilance, drug safety, and therapeutic drug monitoring, making it an essential reading.
Its emphasis on both clinical practice and research provides valuable insights into improving patient safety.
ISSN: 1365-2125
BRITISH MEDICAL JOURNAL (BMJ)
The BMJ is one of the world’s oldest and most respected general medical journals, offering a wide range of research articles, reviews, and opinion pieces.
Its high impact factor and commitment to evidence-based medicine make it essential reading for healthcare professionals.
ISSN: 1756-1833
JOURNAL OF THE ROYAL SOCIETY OF MEDICINE (JRSM)
The JRSM publishes a diverse array of articles that cover all aspects of medicine, including clinical research, public health, and medical education.
This journal is particularly valuable for those interested in the broader implications of medical findings and their application in real-world settings.
ISSN: 1758-1095
Rather then spending your budget for hours of repetitive manual work to monitor those sources, we recommend to simply automate this task using our Tepsivo Literature solution.
Other interesting resources
United kingdom Health Profile
Health Profile for England 2021
The 2021 edition offers a detailed overview of the nation’s health, updating key indicators from previous reports. It provides valuable comparisons with health data from several other countries, making it a crucial resource for understanding current health challenges in England.
It seems that there hasn’t been a more recent health profile yet, so we have to make do with this version.
MHRA's publications
It seems, that MHRA’s annual report can be found only via search when you type “Medicines and Healthcare Products Regulatory Agency Annual Report”, it’s own section is missing.
Pharmacovigilance – how the MHRA monitors the safety of medicines
Quick PDF document that delivers general information on 5 pages.
How is it with qppv in northern ireland?
For medicines placed on the market in Northern Ireland, EU pharmacovigilance requirements continue to apply alongside UK regulations.
Similar to the rest of the UK, MAHs must appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) and maintain a Pharmacovigilance System Master File (PSMF) that describes their pharmacovigilance system.
Scientific publications regarding pharmacovigilance
Changes in pharmacovigilance following the end of the Brexit transition
This article dives into the significant changes in pharmacovigilance legislation in the UK following Brexit, highlighting how the Medicines and Healthcare products Regulatory Agency (MHRA) now navigates its responsibilities across Great Britain and Northern Ireland. Readers can expect to explore the complexities of maintaining safety standards for medicines in a post-Brexit landscape, including the ongoing influence of EU regulations in Northern Ireland and the implications for public health.
An historical overview over Pharmacovigilance
This overview takes readers on a fascinating journey through the 170-year history of pharmacovigilance (also mentioning UK), tracing its evolution from simple clinician warnings to today’s sophisticated electronic monitoring systems.
This study explores the evolution of pharmacovigilance practices around the world, highlighting both the progress made and the ongoing challenges in ensuring the safe use of medicines. Readers will discover how different countries like the US, UK, Canada, and India approach pharmacovigilance, along with insights into improving communication and training among healthcare professionals to create a more harmonized global system.
This study reveals surprising findings about clozapine, showing that while Scandinavian registries found no increased mortality linked to the drug, UK data indicates a significant rise in fatal outcomes associated with its use. Readers will gain insights into the complexities of interpreting these results and discover the potential roles of pneumonia and myocarditis in the higher mortality rates observed in the UK compared to other countries.
Interesting resources
DSUR’s publications regarding drug safety
See various publications from the Drug Safety Research Unit (DSRU), which is a prominent pharmacoepidemiological organization dedicated to monitoring and studying the safety of medicines and vaccines.
EU Exit: Pharmacovigilance for UK authorised medicinal products
This is basically a quick guide with everything important regarding pharmacovigilance you need to know.
Do you need some help with putting the United Kingdom’s PV System together? We’re here for you.
And while you’re here…
…consider also our global end-to-end PV solution!
Thanks to the Tepsivo platform, you can get a full pharmacovigilance system in all countries you need – for a fraction of the usual budget.
Tepsivo Oy | Urho Kekkosen katu, 4-6 E, 00 100, Helsinki, Finland | VAT number FI31367614 | contact@tepsivo.com | +358 402 204 698 | Privacy policy
