Human Tissue Authority

The regulator for human tissue and organs

HTA announcement on inspections and regulatory assessments

Issue date: 
12 October 2020

Following on from our announcement earlier this year on the postponement of our inspection activity, we can now confirm that there will be no scheduled site visit inspections this business year. 

Monitoring and ensuring adherence to HTA Standards, and ensuring public confidence and patient safety, remain priorities, so where there is a requirement we retain the option of conducting responsive site visits in exceptional circumstances. 


Virtual Regulatory Assessments (VRAs)

Our strategic objective to improve the effectiveness and efficiency of our regulation, particularly making better use of data and intelligence, coincided with the inability to undertake site visits since March. This means that we have the opportunity to assess and implement new approaches that can be undertaken remotely. From October we will be starting to undertake Virtual Regulatory Assessments (VRAs), beginning with some establishments in the Human Application sector. 

We will use information we already hold to select establishments for assessment, and then contact establishments requesting the information we need to assess them remotely. 

The information requested from establishments and the way in which it is provided may vary according to their individual profile.  We will be evaluating different methods in our initial assessments, working closely with establishments to ensure we come to fair and transparent conclusions. 

Virtual assessments will evolve and develop as we gain experience in this way of working. VRAs will therefore form an ongoing part of our regulatory toolkit and are just one of the ways in which we can continue to monitor compliance and provide support to drive up standards. 

We are contacting a number of establishments to schedule their virtual regulatory assessment. If you do not hear from us, you do not have to take any further action at this stage. 


Early 2021: safe site visits

In early 2021 we will be looking to return to some form of site visits in the Human Application sector, with a further announcement on this later this year. 

For all other sectors, we are continuing to evaluate how this might work in the current circumstances, with a focus on ensuring the safety of all concerned and minimising the impact on establishments which may be under additional pressures. 


Any questions

Of course, we remain available for any questions you might have on our approach to licensing, monitoring and making assessments during this period. 

If you have a question, please contact us directly. 

Last updated on: 22 Oct 2020