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EU Directives are being put in place for the coding and import of tissues and cells for human application (HA). These will be transposed into UK law during 2016 and the process of writing the UK Regulations is underway.Copies of these Directives and an overview from the Department of Health (DH...
The HTA and MHRA have agreed to extend their existing policy relating to dendritic cells. This extended policy will allow collection of blood as a starting material for an ATMP to be performed under either a Tissues and Cells or Blood Establishment Licence.
The HTA expects establishments to follow the advice provided by the advisory bodies, relevant to the sector in which they operate.
The HTA is the UK Competent Authority for the purposes of the EU Tissues and Cells Directives, which set standards of quality and safety in relation to human tissues and cells intended for human application.
The HTA was asked to share a letter written to the University of Bristol regarding a process taking place at the university in 2008, as part of a process to create an artificial trachea for transplant
The European Commission has launched the web-based EU Coding Platform. The platform is free to access and is designed to help build the Single European Code (SEC) to be allocated and applied to tissues and cells.The EU Coding Platform contains two compendia:
Issued 2 November 2016
Notice for
• Designated Individuals (DIs) in the Human Application (HA) sector • Licence contacts in the Organ Donation and Transplantation (ODT) sector
Issued 10 May 2017
Notice for
• Designated Individuals (DIs) in the Human Application (HA) sector
Scope
Introduction to the Regulations
Licensable activities
Under the Q&S Regulations, the HTA licences and inspects establishments that undertake the following activities using tissues and cells intended for human application: