15 September 2016
Australia can streamline the regulation of therapeutic goods by removing duplicative and inefficient processes without undermining the safety and quality of medicines, according to an independent review of medicines regulation.
The 2015 report of the Expert Review of Medicines and Medical Device Regulation makes 32 recommendations, many of which would improve regulatory efficiency and deliver more timely patient access to generic and biosimilar medicines.
An announcement today by Health Minister Sussan Ley to implement a number of these recommendations is welcomed by the Generic and Biosimilar Medicines Association (GBMA).
“Initiatives to drive regulatory efficiency and reduce the red-tape burden for generic and biosimilar medicine suppliers, without compromising on quality or safety, benefit patients, taxpayers and industry,” GBMA CEO, Belinda Wood said.
“GBMA is highly supportive of improvements in the regulation of medicines that will result in faster approval times for new generic and biosimilar medicines, streamlined administrative requirements and reduced costs for industry,”
“It currently takes just over a year for the Therapeutic Goods Administration (TGA) to evaluate and approve a generic medicine. Reducing this time will bring new affordable medicines to patients sooner, increase treatment options for doctors and deliver savings for the PBS,”
“GBMA also welcomes the recommendation to streamline post-market requirements for medicines as it brings TGA processes in step with respected international regulatory bodies,”
“Enabling changes to products already in the Australian Register of Therapeutic Goods to be made faster, and with less red-tape, will ensure ongoing quality, patient safety and continuity of supply of affordable medicines.” she said.