Working in an increasingly innovative environment, regulatory authorities must balance their essential roles in protecting public health with making sure new, innovative treatments are made available to the UK healthcare sector at the earliest, safest opportunity.
To support these responsibilities, and their ongoing working relationship, the Human Tissue Authority (HTA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have signed a partnership agreement; strengthening a collaboration which began in 2005.
This agreement covers the work of the HTA as the regulator for the safe removal, use and disposal of human tissue and organs in the UK, and of MHRA as responsible for regulating all medicines, medical devices and blood components for transfusion in the UK by ensuring they are acceptably safe and to support the innovation and new products being brought speedily and safely to patients.
The agreement promotes further collaboration and strengthens the commitment to working together for the benefits of patients, staff, and stakeholders and to enhance regulation.
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.
Strengthened collaboration between the HTA and MHRA will contribute to a supportive approach to innovators in the development of new products and services. The agreement will also enable a reciprocal arrangement between the agencies to use investigational knowledge and experience.
MHRA Chief Executive Dr Ian Hudson said: “Our commitment to protecting the health of UK people is aided by creating close ties with regulatory counterparts.
“Working together we will be better able to identify, develop, and support transformative innovations in the UK healthcare sector.
“Agreements such as these help to further strengthen our ability to promote good practices and we look forward to working even closer with the HTA.”
HTA Chief Executive, Allan Marriott-Smith said: “We welcome this agreement as it strengthens our commitment to collaboration for the benefit of patients, staff and stakeholders. By working together, we are able to streamline and simplify the regulatory environment for those we regulate.
“A more collaborative approach to regulation will help us ensure our approach to licensing and inspection is proportionate and efficient. It will also enable us to further support innovation while continuing to ensure that human tissue is used safely, ethically and with proper consent.
We look forward to continuing to work closely with the MHRA.”
- MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency is an executive agency of the Department of Health. www.mhra.gov.uk
- The HTA is the regulator for human tissues, cells and organ. We license and inspect organisations that remove, store and use human tissue for research, medical treatment, post-mortem examination, education and training, and display in public. We also give approval for organ and bone marrow donations from living people.
- The HTA is an executive agency of the Department of Health, established by the Human Tissue Act 2004. The HTA is also the Competent Authority for ensuring the quality and safety of organs intended for Transplantation, and tissues and cells for human application. www.hta.gov.uk