Regulatory Focus™ > News Articles > MHRA Announces Merger of Biologicals Unit with Biological Standards Organization

MHRA Announces Merger of Biologicals Unit with Biological Standards Organization

Posted 09 November 2012 | By Alexander Gaffney, RAC

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is about to become a little bit larger thanks to an agency merger that will see the creation of a new center aimed at better regulating biological products.

The new center, announced 7 November 2012, will merge the National Institute for Biological Standards and Control (NIBSC)-now a part of the Health Protection Agency (HPA)-with MHRA's Biologicals Unit, making it a stand-alone center.

NIBSC currently exists as a standardization agency, responsible for both testing biological medicines and creating standards it touts as being adopted around the world.

In a statement, MHRA said it and NIBSC, "Already work closely together and have common interesting 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."

"The developments will create a new organization 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 medicines industry," wrote NIBSC in a separate statement.

The agencies cited several reasons for conducting the merger, which was prompted by the HPA being absorbed by Public Health England. "Both the MHRA Board and the HPA Board have agreed that NIBSC would better sit with MHRA as their functions provided a much closer fit compared to those functions moving to Public Health England," NIBSC explained. "The transfer will enable both organizations to take advantage of the synergies that exist between the work of NIBSC and the MHRA."

The organizations also cited the opportunity to allow the UK to "compete internationally and better manage the risks and opportunities associated with future development," a possible hint that it aims to speed up regulatory reviews in the near future.

The merger will not take place until 1 April 2013. Until then, wrote NIBSC, "It's business as usual whilst we evolve." The two groups are reportedly already working together to establish the management arrangements and systems needed to ensure a seamless transition. It remains unclear whether MHRA will keep the NIBSC moniker for the new center, or stay with the Biologicals Unit name.

The NIBSC center will be headed by Stephen Inglis, who currently directs the organization within the HPA, which had received control of the NIBSC after an April 2009 merger.


Tags: Biologics

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