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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...
Faecal microbiota transplants (FMT) are recognised as an emerging treatment for recurrent Clostridium difficile infections in patients where antibiotic and other lines of treatment have failed.
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.
Guidance for establishments on meeting HTA licensing requirements for the procurement of tumour samples to be used as a starting material in the manufacture of an Advanced Therapy Medicinal Product (ATMP).
The HTA expects establishments to follow the advice provided by the advisory bodies, relevant to the sector in which they operate.
Importing tissue establishments must ensure that imports from third countries meet standards of quality and safety equivalent to those in the UK. The majority of imports originate in the US and we have identified a number of key differences in regulatory requirements.
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
• Designated Individuals (DIs) in the Human Application (HA) sector • Licence contacts in the Organ Donation and Transplantation (ODT) sector
Introduction to the Regulations
Find out about Licensing under the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended) (the Q&S Regulations).