Is TGA responsible for performing evidence-based evaluations?
A.Such evaluations are performed by the Commonwealth Department of Health and Family Services, a different government agency. The government is setting up an independent advisory committee for this program. Q.Will industry members participate on that committee? A.We’re working on that at the moment, and I think our request for participation will be favorably received. So I anticipate that we will get a seat at the table. Q.What other regulatory concerns does industry have? A.Australia is quickly moving forward on the mutual recognition agreement (MRA) with Europe, and we expect to implement it this year. We look forward to the day when products developed and manufactured in Australia can be assessed in Australia against the European requirements so there won’t be any duplication of assessments. Q.Who will be doing the assessments? A.Initially TGA will act as a notified body. But further down the track, third-party product assessment bodies will be able to participate. Q.How does the de
