Regulatory reform

If you have an enquiry about the TGA's regulatory reform program that is not answered by this website, please see the contact details below.

Regulatory reform consultations

Additional consultations on other matters may also be viewed through the TGA consultations & reviews <http://www.tga.gov.au/consult/index.htm> page.

• Consultation sessions, Parliament House July/August 2008
  <http://www.tga.gov.au/regreform/cons0807.htm>

Advertising of therapeutic goods

• Consultation: Improving advertising arrangements for therapeutic goods
  closed 27 August 2010

Revised arrangements for the scheduling of medicines and chemicals

On Tuesday 29 September 2009, the Governor-General Ms Quentin Bryce AC, gave Royal Assent to the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009: Act No. 96 of 2009. This Act, which covers revised arrangements for the scheduling of medicines and chemicals, comes into effect on 1 July 2010 and can be viewed on the ComLaw website.

The Government agreed, during debate of the Bill to further public consultation on the revised arrangements for the scheduling of medicines and chemicals. In line with this commitment interested parties were provided with the opportunity to comment on cost recovery impact statement (CRIS) and the draft regulations which will amend the Therapeutic Goods Regulations 1990. The Government also committed to the first Chairs of each advisory committee being independent of the Commonwealth.

• Consultation on the draft regulations to implement the revised scheduling framework
  closed 16 March 2010
• Consultation on the Cost Recovery Impact Statement: Regulatory Arrangements for the Scheduling of Medicines, Agricultural and Veterinary Chemicals and Other Substances
  closed 16 March 2010
• Consultation on the Scheduling Policy Framework and Standard for the Uniform Scheduling of Medicines and Poisons
  closed 29 May 2009
  • Public submissions
  • Feedback to public submissions

Regulatory reform program

The Australian Government has agreed to implement a reform agenda to update and streamline the existing regulatory framework for therapeutic goods in Australia.

This will focus on a wide range of regulatory reforms that were developed and consulted on as part of the legislation associated with the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA).

Consultation sessions on regulatory reforms for each therapeutic product sector were held in late July and early August 2008.

• Presentations and outcomes from July/August 2008 consultation sessions
  <http://www.tga.gov.au/regreform/cons0807.htm>

Acts, bills & regulations

• First Act
• Second Act
• Third Act
• Fourth Act
• Fifth Bill
• Amendments to the regulations

Contact details

If your enquiry is not specifically about the regulatory reform program or the prescription medicines business process reform project, see: Contact the TGA <http://www.tga.gov.au/contact.htm>.

Enquiries about the regulatory reform program

If you have an enquiry about the regulatory reform program, please contact:

• Email: reform@tga.gov.au
• Phone:
  • 02 6232 8444
  • 1800 020 653 (freecall within Australia)
  • Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
    • TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
    • Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
• Fax: 02 6232 8605
• Post: Executive Support Unit, TGA, PO Box 100, Woden ACT 2606, Australia

Enquiries about the prescription medicines business process reform project

If you have an enquiry about the prescription medicines business process reform project, please contact:

• Email: bpr.project@tga.gov.au

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