(1) The ATMP Regulation attempts to create a centralised marketing authorisation and harmonised regulatory requirements in the European Union (EU) for three main categories of products, namely gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products (CTMPs) and tissue-engineered products (TEPs).
It deals with the different therapies covered by the ATMP Regulation, that is GTMPs, CTMPs and TEPs, and provides an overview of a number of issues including the design of clinical trials and the bio-safety of GTMPs, the characterisation requirements regarding CTMPs and the assessment procedure for tissue-engineered products.
As noted above, GTMPs are products where genes have been transformed to have a prophylactic, diagnostic or therapeutic effect once transferred into a patient.
Conducting clinical trials for GTMPs remains an issue under the ATMP Regulation.
Information sharing between researchers and regulators also varies greatly between the western EU states and the new member entrants, as does the adoption of standards related to consent provision and bio-safety of GTMPs. It should also be kept in mind that some GTMPs, for instance for the treatment of cancer, are likely to be more effective as adjuvants in combination with conventional therapies.