Standards for biological medicines - understanding them and how they make a difference
The quality of biological medicines is assured by biological standards held by the British Pharmacopoeia (BP) and the National Institute for Biological Standards and Control (NIBSC)
Biological medicines are an increasingly important part of healthcare. Our role as medicines regulator is to make sure the medicines you and your family take are of an acceptable quality. This quality is assured by a regulatory framework which includes compliance to public standards. We have launched a consultation which will look at both how we can best ensure the quality of medicines using standards and how standards can act as enablers for innovation now and in the future.
What is a biological medicine?
A biological medicine is a medicine that is derived from a biological (living) source, such as bacteria or viruses, blood, tissues or living cells in culture. Examples are vaccines, insulin, monoclonal antibodies, blood coagulation factors and recombinant DNA proteins.
Why are biological medicines important?
Biological medicines such as vaccines have long been among the most important medicines available in preventing killer diseases. Increasingly, newly developed biological medicines will play an important role in global healthcare, opening up many possibilities for the treatment of disease and illness.
What are biological standards?
Biological standards are documentary and physical standards used to ensure the quality of biological medicines.
Documentary standards are written descriptions of the quality requirements that medicines have to meet. In the United Kingdom these are published in the British Pharmacopoeia. Physical standards are materials which are used as bench marks in the scientific tests that demonstrate those quality requirements. In the United Kingdom these are produced by the National Institute for Biological Standards and Control (NIBSC).
Who uses standards?
Standards are used by:
- companies that manufacture medicines
- regulatory (government) authorities with a responsibility to ensure the quality of medicinal products
- independent testing laboratories carrying out medical research or other investigations into medicinal quality
Why are standards needed?
Standards are a key component of ensuring acceptable medicines quality. Medicines quality refers to the assurance that medicines are developed and manufactured to predefined and reproducible specifications consistent with the clinically tested product. Standards allow both the public and medical practitioners to have confidence in the quality of the medicines they use.
Can standards enable innovation?
Yes - standards can help enable manufacturers make use of new and innovative technologies. This forms part of the Agency’s broader support for innovation, which includes MHRA’s Innovation Office and Early Access to Medicines scheme.
What is the future for biological standards?
We are working closely with stakeholders on how to improve standards for the future. We have just launched our consultation on documentary standards and would welcome your feedback. The consultation can be found on our website.
Published: 9 January 2017