Human Tissue Authority

The regulator for human tissue and organs

Inspection arrangements and regulatory oversight

We have taken a decision to temporarily suspend all scheduled site visit inspections due to the continued increase in COVID-19 cases across the UK.

Establishments still have a duty to uphold our licensing standards and in order to maintain our regulatory oversight, the HTA will be undertaking remote supervision of licensed activities.

We will monitor activity during this time by carrying out desk-based inspections and acting based on risk. Desk-based inspections may involve establishments being asked to provide electronic copies of documents and other information for review off-site and may be supplemented with teleconferences and email to follow up.

While this new way of working is in place, we will act on our findings proportionately and in line with the level and extent of the licensable activities being undertaken.

This situation remains under review and we will provide further information as it becomes available.

Corrective and Preventative Action (CAPA) plansĀ 

It is important that establishments continue to carry out licensable activities during this period in line with regulatory requirements. However, the HTA understands that establishments may find it difficult to meet pre-agreed target dates for the completion of CAPA plans for various reasons, both internal and external. If this applies to you, please contact the HTA for advice.

Last updated on: 2 Apr 2020