Public consultation – MHRA 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. The Agency would like your input regarding how they are used & can be improved as well as feedback on our draft strategy.
You can contribute by responding to the public consultation on the strategy for pharmacopoeial public quality standards for biological medicines.