MHRA and NIBSC get new Structure on 1 April 2013

On their Homepage, the MHRA published the information that on 1 April 2013 the National Institute for Biological Standards and Control (NIBSC), currently part of the Health Protection Agency (HPA), will officially become a new 'centre' of the Medicines and Healthcare products Regulatory Agency (MHRA) alongside the Clinical Practice Research Datalink (CPRD).

The MHRA and NIBSC already work closely together 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.

The developments will create a new organisation that is a world leader in supporting science and research and the regulation of medicines and medical devices, and will strengthen the support provided to the UK's medicine's industry.

They announced that at first the business will go on as usual and the contacts will remain the same. Furthermore, they published a Question and Answer section with further information about the background, rationale and timeline of these changes, e.g.

What is the rationale for moving NIBSC from the HPA to MHRA?

  • The Health Protection Agency's (HPA) National Institute for Biological Standards and Control (NIBSC) carries out various statutory functions relating to biological standardisation and control of medicines.
  • These were formerly the responsibility of the National Biological Standards Board, but were transferred to the HPA when NIBSC merged with it in April 2009.
  • The Health and Social Care Bill transfers all HPA functions to the Secretary of State, specifically including the functions associated with NIBSC.
  • At the Department of Health's request the Agency Board of the Medicines and Healthcare products Regulatory Agency took the opportunity to reconsider the best organisational model for NIBSC and, following a due diligence process, concluded that the best fit in the future was with the MHRA.
  • The two organisations already work closely together and have common interests in managing risks associated with biological medicines, facilitating development of new ones safely and effectively, and maintaining UK expertise and influence in Europe.

Please also see the announcement as well as the complete Q&A section on the MHRA website.

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