A Century of Setting Standards: The MHRA's Pivotal Role in Ensuring Medicine Safety

Strategic Insights -

For over 100 years, the Medicines and Healthcare products Regulatory Agency (MHRA) has played a crucial role in establishing and maintaining biological standards for medicines and vaccines worldwide. These standards guarantee that medicines work consistently across different countries and manufacturers, giving patients and doctors confidence in their treatments. The MHRA's efforts have been instrumental in saving thousands of lives and have set the benchmark for medical innovation.

Key Takeaways:

  • The MHRA produces over 95% of the World Health Organization's (WHO) biological standards, ensuring consistency and safety in medicines and vaccines worldwide.
  • The agency supplied over 110,000 reference vials to 1,500 different organizations across 81 countries, including product manufacturers, public health laboratories, and hospitals, between October 2024 and September 2025.
  • The MHRA's British Pharmacopoeia sets legally binding quality standards for medicines used in the NHS, forming the backbone of medicine safety in the UK and globally.
  • Biological standards are crucial in ensuring the safety and efficacy of biological medicines, such as monoclonal antibodies, cell and gene therapies, and microbiome research.
  • The MHRA provides over 450 different WHO standards used to develop, test, and monitor biological medicines and ensure laboratory tests give accurate, comparable results.
  • The agency's work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks, guaranteeing the safety and efficacy of medicines and medical devices in the UK.
  • The MHRA's expertise in biological standards has been recognized globally, with the agency working closely with laboratories and scientific organizations worldwide to establish and maintain standards.

Statistics:

  • Over 95% of the WHO's biological standards are produced by the MHRA.
  • The agency supplied over 110,000 reference vials between October 2024 and September 2025.
  • 1,500 different organizations across 81 countries received reference vials from the MHRA between October 2024 and September 2025.
  • The MHRA provides over 450 different WHO standards used to develop, test, and monitor biological medicines.

Sources:

  • Medicines and Healthcare products Regulatory Agency (MHRA) On World Standards Day (14 October),
  • Gupta RK (2025) 'The vital role of biological standardization in ensuring efficacy and safety of biological products – Historical perspectives' Journal of Pharmaceutical Sciences. DOI: 10.1016/j.xphs.2024.12.011.
  • GOV.UK New review highlights untapped potential of the vaginal microbiome in women's health
  • MHRA News Centre (Contact: newscentre@mhra.gov.uk, 020 3080 7651)