Oz & NZ Joint Therapeutic Products Agency Startup
10 February 2005 Media Statement
Australia, New Zealand
announce start-up date
for Joint Therapeutic Products Agency
The New Zealand and Australian Governments have announced a firm operational date for the new Trans Tasman Therapeutic Products Agency of no later than 1 July next year, though it could start earlier.
Health Minister Annette King and Australian Parliamentary Secretary for Health, Christopher Pyne say it is vital to ensure the new regulatory scheme is world class and to recognise the importance of consulting with industry, consumers and other interested parties. "This is a ground breaking move and that is why it is so important to get it right,” says Ms King.
The joint regulatory agency will replace Australia’s Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).
The election cycle in both countries has made it difficult to adhere to the original timetable of establishing the agency in July of this year, Ms King says.
Both Ministers also recognised that industry "needs certainty around the introduction of the new scheme and needs time to review and comment on the rules of the regulatory agency, and to put in place transitional arrangements,” she says.
The role of the new agency will be to safeguard public health through regulation of the quality, safety and efficacy or performance of therapeutic products in both Australia and New Zealand. This includes prescription and over the counter medicines, complementary medicines, medical devices and blood.
The new agency will
be accountable to both the New Zealand and Australian
Governments. It will be recognised in law in both countries
and will assume responsibility for the regulatory functions
undertaken by the TGA and Medsafe.
Ms King said the new agency offered a number of benefits for both countries by creating a single market for drugs and therapeutic products regulation which should ensure that consumers have early access to new products entering the market, while maintaining confidence in public health and safety.
"Over the past three weeks, including today, I have had meetings with representatives of all sectors affected by the establishment of the new agency, starting with pharmaceutical, medical devices and over-the-counter medicines. My last meeting was this morning, with complementary health products representatives, who speak on behalf of more than 75 per cent of the New Zealand market in dollar terms.
"I am very pleased at the commitment they have all given in principle to the establishment of a joint regulator. Between now and the start-up a joint working party of all sectors will work through the remaining details of how the scheme will operate."
More information about the proposed Trans Tasman regulatory agency can be found on www.jtaproject.com