MHRA Unveils Next Steps on Quality Standards for Biologics

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released an update on the agency’s efforts to promote pharmacopoeial quality standards for biologics.

The MHRA said it will establish a group to develop standards for advanced therapy medicinal products that “support quality and innovation.” The agency will also assign a workgroup to develop alternative approaches for biotechnologically produced proteins.

Over the next five years, the agency’s strategy for pharmacopoeial biological standards will be to “review current, new and alternative monograph development approaches for biological medicines, in order to ensure their continued and future suitability as publicly available standards and the safeguarding of public health.”