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In reference to the ABC’s Fact Check article “Will the move to make codeine prescription-only save a100 lives a year” the Therapeutic Goods Administration (TGA) would like to clarify:

s23 instruments supporting the new COR process have been updated.

s23 instruments supporting the new COR process have been updated.

The medicines’ regulator is not proposing and will not be stopping GPs from prescribing high dose opioids

The TGA has issued a discussion paper on the use and misuse of prescription strong opioids, such as oxycodone, and whether there is a need for specific regulatory responses

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under paragraph 61(2)(a)(iii) of the Act to release information from the Adverse Event Management System to the World Health Organization.

Arrangement under section 7C of the Therapeutic Goods Act 1989 for use of computer programs to make decisions.

Approved manner for making an application under section 23 of the Therapeutic Goods Act 1989 in relation to the listing of export only medicine under section 26.

Repeals 48 former notices made between 2005 and 2015 that are no longer required

Arrangement under section 7C(1) of the Therapeutic Goods Act 1889 for the use of computer program to make decisions in relation to the listing of medicines under section 26A and listing of kits for supply in Australia under section 26.

Approved manner for making applications under section 23(1)(a) of the Therapeutic Goods Act 1889 in relation to the listing of medicines under section 26A and listing of kits for supply in Australia under section 26.

Make a request under section 9D of the Therapeutic Goods Act 1989.

Information about the TGA operations over the 2015/16 Christmas/New Year period

Stage two report for the Review of Medicines and Medical Devices has been released

The Therapeutic Goods Administration has published an interim decision on a proposal to up-schedule codeine

The TGA has imposed two new conditions on the inclusion of the SynchroMed II Programmable Pump in the Australian Register of Therapeutic Goods

From 1 July 2015 commercial IVD medical devices will be monitored under the Regulatory Compliance Framework

From 1 July 2015, new guidance and forms for Additional trade names and Extensions of Indications applications will be available

Between 24 May and 16 June, the ACBPS, TGA and APVMA took part in an international crackdown on fake and illegal medicines

The TGA is aware of regulatory action undertaken by the US Food and Drug Administration (FDA) in relation to the Maquet manufacturing facility in Hudson, New Hampshire, USA

Next Tuesday we will be launching the new TGA Business Services site.

The TGA and NPS Medicinewise have worked together to create two interactive online learning modules