Strategy for pharmacopoeial public quality standards for biological medicines

Biological medicines are an increasingly important part of healthcare worldwide. Their quality is assured by a regulatory framework which includes compliance to public quality standards. Both documentary and physical standards work together to ensure that biological medicines are of acceptable quality for use by the patient.

In the UK, documentary standards exist as texts published in the British Pharmacopoeia. The Medicines and Healthcare products Regulatory Agency is developing a strategy for the creation of pharmacopoeial public quality standards for biological medicines. This public consultation seeks input from stakeholders regarding how they are used and can be improved as well as feedback on the Agency’s draft strategy.

You can respond to this consultation by using the form in the consultation document, or by downloading the Microsoft Word version above. Responses should be sent to BiolStandards@mhra.gov.uk by 10 April 2017.

In this document there is:

• an introduction
• a draft pharmacopoeial biological standards strategy
• a response form