Posted by Michael Wonder on 12 May 2020
FDA's drug approval system is more open than Australia's
11 May 2020 - Australia’s secretive drug approval system gives what some believe is an unfair advantage to rival drug companies.
As far as innovator companies are concerned, as well as the public, Australia’s process for approving generic and biosimilar agents is too secretive.
There are no strict requirements that drug makers looking to bring a rival product to market need to inform the innovator companies until very late in the process, once marketing approval has been given and the product is about to appear on the Australian register of drugs.
