In the run up to the end of the UK’s transition period within the European Union, the UK Government and Human Tissue Authority (HTA) have issued guidance for the cell and gene therapy industry, active from 1 January 2021.
The guidance below encompasses regulatory changes to the quality and safety of human organs, tissues and cells, HTA licensing and changes to the Medicines and Healthcare products Regulatory Agency (MHRA). It is imperative that all organisations involved in the UK cell and gene therapy industry is aware of the following information.
Guidance regarding the quality and safety of human organs, tissues and cells
The UK Government has issued guidance regarding the quality and safety of human organs, tissues and cells from 1 January 2021, which can be found here.
This information encompasses:
- Guidance for hospitals, tissue establishments and fertility clinics for ensuring the quality and safety of human organs, tissues and cells (including reproductive cells).
- Quality and safety standards for organs, tissues and cells
- Importing and exporting organs for transplantation from 1 January 2021
- Sending and receiving non-reproductive tissues and cells for human use if you are a tissue establishment in Great Britain
- Sending and receiving non-reproductive tissues and cells for human use if you are a tissue establishment in Northern Ireland
- Sending and receiving reproductive tissues and cells for human use if you are a centre in Great Britain licenced by the Human Fertilisation and Embryology Authority (HFEA)
- Sending and receiving reproductive tissues and cells for human use if you are a centre in Northern Ireland licenced by the HFEA
- Ensuring traceability of all tissues and cells
Changes to Human Tissue Authority (HTA) Licensing
The Human Tissue Authority (HTA) updated guidance on their website on what HTA-licensed establishments must do to prepare for the end of the transition period. This can be found here.
HTA establishments regulated under the Human Tissue Act 2004 and the Quality and Safety of Organs Intended for Transplantation Regulations 2012 will not require changes to their licence after the end of the transition period.
However, establishments that are licensed under the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 may require changes to their licence. This applies to establishments in Human Application sector that from 1 January 2021 intend to:
- receive tissues or cells from countries within the EU (import); or
- send tissues and cells to countries within the EU for human application (export).
Some organisations may need to vary their licence in order to continue these activities post-transition. This includes establishments who intend to import or export tissues and cells as the starting material for the manufacture of an Advanced Therapy Medicinal Product (ATMP).
Guidance relating to the Medicines and Healthcare products Regulatory Agency (MHRA)
From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator. Stakeholders need to get ready for new rules from 1 January 2021.
The MHRA guidance can be found here, and it encompasses:
- Guidance on clinical trials
- Regulating medical devices
- Changes to licensing and authorisations
- Importing and exporting guidelines
- Guidance on IT systems
- Pharmacovigilance procedures