MHRA has released the response to January’s consultation on the strategy for pharmacopoeial public quality standards for biological medicines

In January 2017, MHRA launched a public consultation on pharmacopoeial quality standards for biological medicines. 

The consultation posed specific questions to understand stakeholders’ perspectives on biological medicines, how biological quality standards should be developed, what they should look like and how they can enable innovation, and how the Agency can best engage with users. The consultation was received positively by stakeholders and a wide range of responses were received representing trade associations, manufacturers, academia/researchers and peer organisations. 

We are pleased to inform you that the Agency has now published its official response to the consultation.

We would like to thank all those who shared their views with us. If you have any further questions on the consultation response, please contact us on