Human Tissue Authority

The regulator for human tissue and organs


To ensure that the HTA’s regulatory approach remains relevant, we actively prepare for the future. We do this through our development activities. As outlined in the Strategic Review section, in this three year period our development goals will focus on building our resilience, agility and overall sustainability as an organisation in addition to maintaining our programme of continuous improvement activity.


We see innovation across all the sectors we regulate and actively horizon scan to keep abreast of developments to inform our work, often in collaboration with other organisations. The pace of change requires a highly responsive regulatory framework that supports innovative uses of organs, tissues and cells.

Where emerging issues can be accommodated within the current regulatory framework, we will work to achieve this with agility, proportionality and appropriate assessment of risk. Where they cannot, we will advise relevant Government, professional and public stakeholders, and actively consider the use of soft law tools where this is appropriate.

In the Human Application sector, we will continue to work closely with the Medicines and Healthcare products Regulatory Agency and other regulatory bodies on the Regulatory Advice Service for Regenerative Medicine (RASRM), which we see as a key foundation for the future regulation of novel tissue and cell therapy based products. We will further strengthen our regulation through implementation of the recommendations from our recent review of risk in the Human Application sector.

In living organ donation, we are seeing increasingly complex cases and wider use of the UK living kidney sharing scheme, placing pressure on staff resource. The sustainability of the Independent Assessor framework remains a significant strategic issue, and we have undertaken a project to review options for putting this on a more sustainable footing, with a view to implementation during 2018/19.

Improving compliance

Although in general we see a high level of compliance in our establishments, we have recently seen a number of issues emerge which have had an impact on the number of shortfalls we find. We will use the data and information we hold, and our close links with key stakeholders, to implement a targeted approach aimed at addressing these issues.

Better use of data and information

We already use data and information to inform our risk-based approach to regulation. We recognise that we can improve the quality and make better use of the data and information we hold, in order to ensure we identify trends and prioritise and target our resources effectively across the organisation.

Organisational change

In addition to seeking improvements in our regulatory processes, this strategic period will see us invest significant resources in developing our people, business technology and estates planning. Balancing the use of resources for development and improvement against our core delivery activities will mean a greater emphasis on being clear about our priorities, and promotion of a cohesive, organisation-wide approach to addressing key business concerns.

Further details on how we will shape our future approach are described in the deployment section of this strategy.

Influencing others

We will ensure we reflect our experience of regulating our diverse sectors in submissions and dialogue on the future of regulation, particularly in the context of the Government’s Industrial Strategy and EU Exit. We will be available to offer advice and guidance to colleagues across government and beyond as and when it is needed.

Development objectives

Our development objectives are:

  • Use our data and information to provide real-time analysis, giving us a more responsive, sharper focus for our regulatory work and allowing us to target our resources effectively;
  • Make continuous improvements to our systems and processes to minimise waste or duplicated effort, or address areas of risk;
  • Provide an agile response to innovation and change in the sectors we regulate, making it clear how to comply with new and existing regulatory requirements;
  • Develop a blueprint for a future operating model, which builds our agility, resilience and sustainability as an organisation.

In the period covered by this strategy, we will:

  • Implement the recommendations from our evaluation of risk across the human application sector and amend our approach as necessary;
  • Implement the recommendations from the Independent Assessor Sustainability project;
  • Continue to work with establishments to ensure as smooth a transition as possible in implementing the EU Coding and Import Directives and any changes resulting from the UK’s Exit from the EU;
  • Continue to develop our approach to engaging with licensed establishments as a key tool in ensuring compliance;
  • Develop tools to improve how we prioritise and plan our regulatory activities and manage our resources, including more effective use of information and data;
  • Continue to upgrade and develop our core business systems, website, and online portal to better meet our business needs and the needs of our stakeholders;
  • Continue to use our unique position to advise Government in matters relating to our remit;
  • Plan, develop and implement an organisational transformation programme.
Last updated on: 23 May 2018