Australia TGA explains transition provisions for human tissue-based products
This article was originally published in Clinica
Executive Summary
Sponsors of human cellular and tissue-based therapies currently on the market in Australia who apply for formal product registration by 30 November this year will get a guarantee that their products will remain on the market after May 2014 – when new rules on the licensing of biologicals become mandatory – if an official assessment of the product has not been completed by then.