Australia TGA explains transition provisions for human tissue-based products
This article was originally published in Scrip
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.
You may also be interested in...
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EMA Hopes New Requirement Will Make Companies Stick To Their Filing Plans
An additional form that marketing authorization applicants must now complete during the pre-submission stage emphasizes the importance of companies providing accurate information on their intended submission date.
EMA To Get The Ball Rolling On Making CTIS Global
The European Medicines Agency wants to further improve the visibility of data in the Clinical Trials Information System by establishing it as a World Health Organization primary registry.