On 8th December 2016, the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Human Tissue Authority (HTA) signed a partnership agreement strengthening their existing collaboration. The agreement should see a strengthening of the working relationship between the two bodies.
This agreement covers the work of the HTA as the regulator for human tissues, cells and organ safe removal, use and disposal and of the MHRA who are responsible for regulating all medicines, medical devices and blood components for transfusion in the UK, to ensure a positive benefit risk profile. Both agencies have a responsibility for safeguarding public health and also supporting innovation to ensure the rapid availability of new products.
The main areas of cooperation are joint advice through the ‘One Stop Shop’ regulatory advice service for regenerative medicine (RASRM), joint inspections of Tissue Establishments and advanced therapy medicinal product (ATMP) manufacturing sites, and a joint position on the use of blood for ATMP manufacture.
Enhanced collaboration between the HTA and MHRA should contribute to a supportive approach to innovators in the development of new products and services.
It is good to that these regulatory authorities recognise the need to balance their vital roles in protecting public health with making sure new, innovative treatments are made available to the UK patients at the earliest opportunity.
To read the full MHRA announcement, click here.