100 years of protecting patients through biological standards for medicines
Source: gov.uk (2025-10-14)

The MHRA produces over 95 per cent of the World Health Organization’s (WHO) biological standards.

On World Standards Day (14 October), the Medicines and Healthcare products Regulatory Agency (MHRA) marks 100 years since the first biological standard – the scientific benchmark that keeps medicines and vaccines safe, effective and consistent for patients in the UK and worldwide.

When someone receives a medicine, it must work the same way no matter wherever it is made. Biological standards make sure that a medicine produced in one country performs exactly as it would if it were made somewhere else – giving patients and doctors confidence that treatments can be trusted.

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.”

At the MHRA’s science campus, experts prepare and distribute over 95 per cent of the World Health Organization’s (WHO) biological standards. In the past year, the MHRA supplied over 110,000 vials or ampoules to 1,500 different organisations across 81 countries, including product manufacturers, public health laboratories and hospitals.

In the UK, the MHRA’s British Pharmacopoeia (BP) sets legally binding quality standards for medicines used in the NHS. Together, these two areas of the agency form the backbone of medicine safety – in the UK and globally.

What are biological standards?

Every medicine must be tested to make sure it works as intended. For most, this can be done using chemical or physical tests, such as measuring the amount of a particular ingredient. But some medicines, especially those made from living cells or biological material, can’t just be checked by measuring what’s in them – scientists also need to measure how strongly they work. To do this, they use special biological tests, called bioassays, which can naturally vary in their results. Biological standards are used to make sure these tests give reliable and consistent results.

Biological standardisation, including the use of reference materials, means everyone, from doctors and scientists to regulators and manufacturers, can talk about a medicine’s strength, dose or diagnostic result in the same way, using a shared scientific language.

Without biological standards, doses could vary from one manufacturer to another, or even from batch to batch, putting patients at risk.

A century of setting standards

The concept of biological standardisation began with efforts to make treatments for diphtheria more consistent. At the time, diphtheria was a leading cause of childhood deaths, and the strength of antitoxin treatments varied widely between manufacturers. This meant one doctor’s ‘effective’ dose might be another’s overdose. The new standard allowed consistent dosing and saved thousands of lives.

Building on this, British scientists established the first international biological standard for insulin in 1925. A vial of the original insulin standard, created to ensure consistent diabetes treatment, is still preserved at the MHRA’s science campus today.

Modern medicine and future standards

A hundred years on, the MHRA continues to lead in developing biological standards for new therapies – from monoclonal antibodies to cell and gene therapies. The MHRA now provides more than 450 different WHO standards that are widely used to help develop, test and monitor biological medicines and to make sure laboratory tests give accurate, comparable results.

Standards are also becoming vital for fast-moving areas of science such as microbiome research – the study of the trillions of bacteria and other microorganisms that live in and on the human body.

For a century, biological standards have provided a framework that keeps medicines safe and effective. From early medicines to cutting-edge therapies, MHRA scientists continue to ensure that every medicine can be trusted to do what it’s meant to – protecting patients and supporting global research.

Notes to editors

The MHRA supplied over 110,000 reference vials between 10 October 2024 to 30 September 2025.

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 (https://www.sciencedirect.com/science/article/pii/S0022354924006142?via%3Dihub).

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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.

The MHRA is an executive agency of the Department of Health and Social Care.

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