This week, the UK Medicines and Healthcare products Regulatory Agency (MHRA) marked the centenary of the first biological standard being introduced on World Standards Day.
Biological standards provide scientific benchmarks that ensure medicine development and manufacturing are consistent across different companies and countries.
These standards were first introduced in the early 20th century to regulate diphtheria treatments, where variability in antitoxin potency between manufacturers posed significant safety risks. The first international biological standard, established in 1925 for insulin, ensured consistent treatment for people with diabetes.
Today, scientists at the MHRA’s science campus prepare and distribute more than 95% of the biological standards endorsed by the World Health Organization (WHO). Between October 2024 and September 2025, the agency supplied over 100,000 ampoules or vials to 1,500 organisations across 81 countries, including product manufacturers, hospitals and clinics, as well as public and private laboratories.
The MHRA also contributes to the development of biological standards for emerging therapies, such as monoclonal antibodies and cell and gene therapies. The agency currently provides more than 450 WHO standards used to develop and evaluate biological medicines, ensuring accurate and reproducible results. Similarly, the British Pharmacopoeia – a division of the MHRA – sets legally binding quality standards for medicines used by the NHS, guiding safe and reliable administration.
Paul Bowyer, deputy director, Standards Lifecycle, at the MHRA, said: “The biological standards developed, produced, curated and supplied by the MHRA not only support the safe development, testing and use of a wide range of medicines, vaccines and diagnostic tests, but also make it possible for scientific discoveries to be compared, repeated and built upon. This involves experts from across the Science & Research Group at the MHRA, working closely with laboratories around the world.”