Still awaiting official confirmation over HTEP (human tissue engineered products) transfer:
This article was originally published in Clinica
Formal confirmation of the transfer of human tissue engineered products to the pharmaceuticals unit of the European Commission, and an associated change in regulatory orientation, did not happen at the Medical Devices Experts Group (MDEG) meeting in Luxembourg on April 12-13. It had been thought that a representative from the pharmaceuticals unit within Directorate F present would be present, but there is ongoing speculation that formal clearance to make the announcement was - and still is - awaited. The indications are that the Commission is to regulate human tissue engineered products, henceforth to be known as Advanced Therapies, alongside pharmaceuticals, thus dropping the concept of the separate "third pillar" of regulation.