Regenerative medicine and the regulation of advanced therapies medicinal products

HTA licensing for those working with ATMPs

The procurement and testing of human tissues or cells used as starting materials in the manufacture of ATMPs, may only be carried out by establishments holding an appropriate HTA licence or by individuals or organisations working under the authority of a third party agreement with an establishment holding an appropriate HTA licence.

This applies to all tissues and cells which are covered by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended).

Specific information on the regulation of embryonic stem cell lines.

The HTA and MHRA have also established a joint position whereby the collection of blood as a starting material for an ATMP can be carried out under either a tissues and cells licence or a blood establishment licence.

Other HTA licensable activities

Establishments which import, export or store tissues and cells intended to be used as the starting material in the manufacture may require an HTA licence for these activities. A licence for processing may also be needed if the tissues or cells are processed prior to the commencement of manufacturing. Examples of where this could apply would be the derivation of early cell lines or banks prior to establishing a Master Cell Bank (MCB), or the banking of tissue where the future use is unknown but could include the manufacture of an ATMP.

A member of the HTA Regulation Team will be able to advise further on HTA licensing requirements for ATMPs.