100 Years of Protecting Patients Through Biological Standards for Medicines

15th October 2025

100 Years of Protecting Patients Through Biological Standards for Medicines

The Medicines and Healthcare products Regulatory Agency (MHRA) marks 100 years since the establishment of the first biological standard, a milestone that has been pivotal in maintaining the quality of medicines and vaccines globally. Biological standards are essential for ensuring that medicines produced in different countries perform identically, providing patients and healthcare professionals with confidence in their reliability.

Over the past year, the MHRA supplied over 110,000 vials or ampoules of biological standards to 1,500 organisations across 81 countries, including product manufacturers, public health laboratories, and hospitals. These standards are crucial for the development, testing, and use of a wide range of medicines, vaccines, and diagnostic tests. They also facilitate scientific discoveries by ensuring that results are consistent and comparable across different studies and regions.

In the UK, the MHRA's British Pharmacopoeia sets legally binding quality standards for medicines used in the NHS. Together with the biological standards produced at the MHRA’s science campus, these frameworks form the backbone of medicine safety in the UK and worldwide.

Link: 100 Years of Protecting Patients Through Biological Standards for Medicines

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