Strategy for pharmacopoeial public quality standards for biological medicines

The Medicines and Healthcare products Regulatory Agency (MHRA) recognises the important role that biological medicines have in protecting public health and has developed a Strategy for pharmacopoeial public quality standards for biological medicines. In order to inform the strategy, the MHRA ran a public consultation which sought to understand stakeholders’ perspectives on biological medicines, how biological quality standards should be developed, how they can enable innovation, and how the MHRA can best engage with users. The consultation was received positively by stakeholders with a wide range of responses representing trade associations, manufacturers, academia and researchers, and peer organisations. The consultation response has subsequently been published.

The consultation ran from January 2017 to April 2017. A public response to the consultation was published in October 2017. A public update on the implementation of the strategy was published in September 2019.

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Consultation outcome: Strategy for pharmacopoeial public quality standards for biological medicines