Release date: 2015-04-14
The European Commission announced on the 9th that it has approved two new regulations on human tissue and cell management for transplantation to ensure compliance with EU quality and safety standards and to protect the rights of patients undergoing transplantation.
The first rule is mainly for the management of human tissues and cells within the EU. The most important element is the establishment of a “single European code†containing the main features and information for transplanted human tissues and organs, ensuring that all human tissues and cells circulating within the EU are uniformly identified. This makes it easy to track all the information about human tissue and cell donors and recipients.
In the event of a security alert, this identification will help all patients receiving tissue and cells from the same donor to be traced and treated as needed. This move also ensures that problematic tissues and cells that are not yet in use are not used.
The second rule is mainly for the transplantation of human tissues and cells from sources other than the EU. Specific content includes ensuring traceability of donors and recipients. Imported transplanted human tissues and cells must be transplanted by designated recipients and not used by Others, and ensure that these human tissues and cells meet EU safety and quality standards. Member States should be fully aware of the situation of suppliers in third countries and share relevant information with the European Commission and other EU member states when needed, which will help to ensure the safety of patients receiving human tissue and cell transplantation.
The European Commission stressed that the relevant institutions of member states should strictly implement the new regulations and encourage member states to adopt more stringent regulatory measures.
Source: Xinhuanet
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