The National Institute for Biological Standards and Control (NIBSC), previously part of the Health Protection Agency (HPA), is now a new centre of the Medicines and Healthcare Products Regulatory Agency alongside the Clinical Practice Research Datalink (CPRD).
The MHRA and NIBSC have worked closely together for many years and have common interests in managing risks associated with biological medicines, facilitating development of new medicines safely and effectively, and maintaining UK expertise and ability to contribute to assuring the quality and safety of medicines in Europe and beyond.
These developments have created a new organisation that is a world leader in supporting science and research and the regulation of medicines and medical devices, strengthening the support provided to the UK’s medicine’s industry.
The new Medicines and Healthcare Products Regulatory Agency group consists of:
MHRAThe MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all our work lies robust and fact-based judgements to ensure that the benefits justify any risks. This is achieved through:
The Clinical Practice Research Datalink (CPRD)
The National Institute for Biological Standards and Control (NIBSC)
a) Biological reference materials and customized reference materials
b) OCABR testing and contract testing
c) Research collaborations
d) Advice and training
Its statutory duties are:
As part of the same organisation, the three bodies will continue to provide all the same services and products as before, but in a more integrated way, helping to protect public health whilst bringing products to market reliably, efficiently, economically and safely through. The new organisation offers:
As a result of the changes we have updated the MHRA, NIBSC and CPRD identities to better reflect the expanded organisation and have introduced a Medicines and Healthcare Products Regulatory Agency family identity. You will start to see these being used on our materials in the coming months, from 1st April 2013.
More information on each of the centres is available on their website:
NIBSC https://nibsc.ac.uk/ (please note this has changed although your browser will redirect if you use the old URL)
CPRD http://www.cprd.com/ The MHRA and CPRD website addresses remain unchanged.