Australia TGA explains transition provisions for human tissue-based products
This article was originally published in Scrip
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.
You may also be interested in...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-four guidance documents have been posted on the tracker since its last update.
The risk of psychiatric disorders with chloroquine and hydroxychloroquine-containing medicines received renewed attention in the EU after they were being used as potential treatments for COVID-19.
New UK guidance explains how clinical trial sponsors and investigator sites can ensure that trial monitors securely process data in electronic health record systems that do not have a restricted access functionality.