Oz, NZ Therapeutic Products Authority for 2007
Joint Australia and New Zealand Therapeutic Products Authority Planned for Next Year
CANBERRA, May 11/MediaNet International-AsiaNet/ --
Therapeutic Products Interim Ministerial Council
MEETING OUTCOME STATEMENT
The proposed trans Tasman joint regulatory scheme for therapeutic products is expected to begin in the second half of 2007, Australian and New Zealand Government representatives announced today.
Following a meeting of the Therapeutic Products Interim Ministerial Council, held in Melbourne, the New Zealand Minister of State Services, Annette King and the Australian Parliamentary Secretary for Health, Christopher Pyne said they were pleased with the steady progress being made towards the establishment of the Australia New Zealand Therapeutic Products Authority (ANZTPA) and the beginning of the joint regulatory scheme.
Industry consultations need to be completed and legislation introduced into the parliaments of both countries before a final commencement date of the joint regulatory scheme is decided,” Ms King said.
“However, we are committed to and confident about the processes so far,” she said.
Mr Pyne said stakeholders will be given at least six months notice of the commencement date and there will be a three year transition period for products to ensure that industry and consumers can adapt to any changed conditions.
“Submissions from industry, consumers and other interested people will soon be sought on the draft rules for the new agency covering medicines, medical devices, and administrative matters, along with comments on a discussion paper outlining the proposed approach for fees and charges.
“A round of public consultation in New Zealand and Australia also begins in June this year,” Mr Pyne said.
ANZTPA will replace Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medicines and Medical Devices Safety Authority (MedSafe). The new Authority will regulate prescription and over-the-counter medicines, complementary medicines, medical devices and blood and blood products, tissue and cellular therapies in both countries.
“The proposed joint regulatory scheme will be administered by a single authority with fully functional offices in both countries. This international development will continue our two countries’ long-standing relationship and further the advancement of a more integrated trans-Tasman economy,” Ms King said.
“Doing it properly is one of the main reasons establishing the Authority has taken longer than we had initially hoped.”
“We are confident ANZTPA will produce a strengthened regulatory system that has at its core the protection of the health and safety of people in both countries,” Mr Pyne said.
More information about the proposed trans-Tasman regulatory agency can be found on www.anztpa.org
SOURCE: Department of Health and Aging