1. Cornea and sclera fall under the EU Tissue and Cells Directive 2004/23/EC and Commission Directives 2006/17/EC and 2006/86/EC. These Directives have been transposed into UK law through the Human Tissue (Quality and Safety for Human Application) Regulations 2007.The EU Directive requires tissue establishments to be licensed and tissue banks in the UK are licensed by the Human Tissue Authority (www.hta.gov.uk), the relevant UK Competent Authority for the purposes of the EU Tissues and Cells Directive.
The EU Tissue and Cells Directive set the minimum mandatory standards for tissue banks. Additional advice and guidance is provided by:
2. Limbal Stem Cells/somatic cell therapies are classed as Advanced Therapy Medicinal Products. The regulatory framework for advanced therapy medicinal products (ATMPs) is established by Regulation (EC) No 1394/2007 on advanced therapy medicinal products. Regulation (EC) No1394/2007 on advanced therapy medicinal products amended Directive 2001/83/EC and Regulation (EC) No 726/2004. Licenced products require centralised European marketing authorisation following assessment by the European Medicines Agency (EMA). Unlicensed products, exempt from central authorisation can be supplied under the derogation permitted in Article 5(1) of Directive 2001/83/EC. Preparation on a non-routine basis in a hospital is permitted without central authorisation under Article 3 (7) of 2001/83/EC. The Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk) is responsible for regulatory arrangements under the exemptions in the UK.
The ATMP Regulation (No 1394/2007) came into force on 30 December 2007. The UK’s legislation for implementing the Regulation under hospital exemption came into force on 19 August 2010. Manufacture of advanced therapy medicinal products should be in compliance with the principles of good manufacturing practice, as set out in Directive 2003/94/EC.
3. Autologous Plasma and Serum eye drops are regulated under the transposition into UK law by the Blood Safety and Quality Regulations 2005 of EU directives 2001/83EC, 2002/98/EC and 2004/33/EC. The UK Department of Health has designated the Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk) as the relevant UK Competent Authority. Notification of serious adverse events and quality systems are regulated under Directives 2005/61/EC and 2005/62/EC.