Greg Neal

Regulation Manager Human Tissue Authority

"The HTA regulates tissues and cells used in patient treatment. When these tissues and cells, or products derived from them, become classified as medicinal products, they are regulated by the MHRA.

"For some time, the MHRA and the HTA have discussed ways of improving the efficiency of regulation of processes that may fall under the remits of both the MHRA and the HTA, to help reduce the time establishments spend preparing for inspections.

"The HTA undertook a pilot joint inspection with the MHRA. This joint approach meant the establishment had to prepare for only one inspection. We were able to work with the MHRA to share information on inspection approaches and define where our regulatory remits adjoin. We also found it beneficial to understand Altrika’s production process from beginning to end, so that we could put the HTA’s regulatory remit in context."