Mifepristone TGA Application process
MIFEPRISTONE
This medication is widely used in other countries and there is extensive scientific evidence that it is safe and effective.
For women who have higher surgical or anaesthetic risks and those who seek to avoid surgery, medical abortion has the potential to provide a lower risk or more acceptable alternative to surgery.
Medical abortion is already available in South Australia. In the first trimester, regimens utilising methotrexate and misoprostol are employed. The combination of mifepristone and misoprostol is more effective and involves less risk of serious adverse effects. In the second trimester, induction of labour using misoprostol is currently in use. When added to this regimen, mifepristone reduces the time taken to complete the abortion and the amount of pain experienced.
Mifepristone is also indicated for cervical preparation prior to first and second trimester surgical abortions. Surgical abortion presents less risk to a pregnant woman than continuing a pregnancy to term. The rate of adverse outcomes may be reduced further by pre treatment with mifepristone which reduces the requirement for mechanical dilation of the cervix during surgery and the time taken to complete the procedure.
Since the Australian Parliament returned responsibility for regulation of the use of mifepristone to the Therapeutic Goods Administration, there has not been an application from a manufacturer to market it in Australia. In the absence of marketing approval, the only avenue for medical practitioners to use mifepristone has been to apply individually to the Therapeutic Good Administration for authorisation to prescribe it. Authorisation to prescribe mifepristone (in quite restricted circumstances) has been granted to a number of medical practitioners in other States. Medical practitioners at the Pregnancy Advisory Centre have gained approval from the Therapeutic Goods Administration to prescribe mifepristone for abortions which meet the requirements of South Australian law for these indications;
-
Medical abortion the first trimester
-
Medical abortion in the second trimester
-
Cervical priming prior to surgical abortion in the first and second trimesters
The Application process
More than 80,000 women have pregnancy termination procedures in Australia each year and more than 4,500 of these are in South Australia. Many of them could benefit from mifepristone. We invite medical practitioners seeking authorisation to prescribe mifepristone to contact the Centre for advice on submission of a successful application.
The Therapeutic Goods Administration provides instructions to applicants here:
http://www.tga.gov.au/docs/html/authpres.htm
For further enquiries about this process please contact the Centre on (08) 8243 3999.
Abortion in SA or Abortion SA Abortion Adelaide Termination in SA or Termination SA Termination Adelaide Pregnancy options Pregnancy Termination Pregnancy ChoicesUnplanned pregnancy Unplanned pregnancy options/ choices Abortion options Termination of pregnancy options Surgical abortion Adelaide/SA Abortion RU 486/ Mifepristone Adelaide /SA First trimester abortion Second trimester abortion Pregnancy options counselling Unplanned pregnancy counselling Pregnancy counselling Decision making counselling pregnancy Counselling for abortion Pregnancy Support Adelaide- Abortion women emotions
