TGA News Issue 54 (November 2007)
Medical device transition ends
Midnight 3 October 2007 saw the official end of the five year transition of medical devices to the new regulatory framework. The new regulatory framework was introduced with the support of the medical device industry as it moved Australia to an internationally harmonised regulatory framework consistent with the outcomes from the Global Harmonization Task Force (GHTF) for medical devices.
During the five year period the TGA worked closely with industry and Australian sponsors, particularly so over the last two years, to ensure that sponsors were aware of the deadline and the need to transition their products. The TGA has also worked with the States and Territories through the National Co-ordinating Committee on Therapeutic Goods to help purchasing authorities and hospitals assess the continued availability of products identified as pivotal to the provision of health services in the various jurisdictions.
In response to concerns raised about ongoing access to important medical devices, the terms of the Transition deadline were amended by the passage of the Therapeutic Goods Amendment Act 2007. Under the amended terms of the deadline, sponsors are able to continue to supply registered and listed therapeutic devices that were the subject of an effective application for either inclusion in the Australian Register for Therapeutic Goods (ARTG) or for TGA conformity assessment as at midnight 3 October 2007.
For those products, once they are 'included' in the ARTG, the registration or listing under Chapter 3 of the Act will be removed from the Register and all subsequent supply of the product must be in accordance with the terms and conditions set out in Chapter 4.
Therapeutic devices for which no application to transition was received prior to 4 October 2007 are taken to be cancelled from the ARTG and can no longer be supplied. More detailed information can be found on the TGA website: Medical devices transition 4 October 2007 <http://www.tga.gov.au/devices/tp2007.htm>.
Currently the TGA is working systematically through the ARTG to ascertain which products are required to transition and which are not and, of those required to transition, which products have completed transition, which products are under but have not yet completed transition, and which products are not transitioning.
Cooperative arrangement with the US FDA
The TGA is delighted to announce that it has finalised a new five year cooperative arrangement with United States Food and Drug Administration (US FDA). The final stages of this important cooperative arrangement were completed during the recent visit to the TGA by Dr Murray Lumpkin, Deputy Commissioner US FDA.
The TGA and the US FDA have a long history of regulatory cooperation. This is particularly important in an era where the globalisation in the manufacture of human pharmaceutical products presents common challenges and opportunities for national therapeutic product regulators to explore cooperative arrangements.
This cooperative arrangement will significantly enhance information exchange between the TGA and the US FDA. It will facilitate more efficient regulation and information exchange in many areas including:
- sharing information about prospective inspection schedules, particularly in relation to inspections of manufacturers in other countries
- inspection outcomes and prospective inspection schedules
- sharing Good Manufacturing Practice information from manufacturers located in other countries
- providing information on TGA audits of US complementary medicine manufacturers who export to Australia
- the FDA providing, upon request, the TGA with Establishment Inspection Reports. This would be reciprocated by the TGA
- inspection information or official test results about a potential health hazard, recalls, and market withdrawals
- sharing remote access to a computerised database summarising site-specific information, such as legal status, location, operations, and inspection dates, or any database similar to COMSTAT that contains recall data, inspectional data, refusal information, and analytical data supporting an import alert, and
- information on firms that potentially counterfeit or substitute Active Pharmaceutical Ingredients.
All sharing of information between the FDA and TGA under this new arrangement, and the treatment of received information, will be conducted in accordance with a pre-existing Confidentiality Commitment between the agencies signed on 11 August 2004.
Dr Murray Lumpkin, US FDA (left), Dr Rohan Hammett, TGA (right)