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Complementary medicines reforms
12 December 2019
Older, revoked and superseded notices are available in the TGA Internet site archive.
- Outcomes of the Lower Risk Registered Over-the-Counter (OTC) Products Review Pilot Project
3 January 2020: A Lower Risk OTC Products Review pilot project was developed in response to recommendation 14 of the Medicines and Medical Device Regulation Review (MMDR)
- Publication of a list of Comparable Overseas Bodies
4 December 2019: On 4 December 2019, the TGA published a list of Comparable Overseas Bodies (COBs). Evaluation reports from COBs on this list may be used to support submissions for the evaluation of registered complementary medicines, assessed listed medicines and substances for use in listed medicines
- Publishing results of listed medicine compliance reviews
27 November 2019: From December 2019, the TGA will publish the results of all compliance reviews relating to safety and efficacy of listed medicines
- Update on TGA assessed claim for assessed listed and registered complementary medicines
9 October 2019: The TGA has published guidelines for using the TGA assessed claim on medicine labels
- The fee-free period for sponsors to transition existing listed medicines to permitted indications has been extended
12 Sep 2019: The TGA has extended the 'fee-free' period for sponsors of existing listed medicines to transition to using permitted indications until 6 March 2021.
- Upcoming changes to the Permissible Indications Determination
14 Aug 2019: A complete list of pending changes to the Permissible Indications Determination
- Changes to nappy rash products
26 Jul 2019: Changes will be made to the regulation of nappy rash products on 1 January 2020
- TGA assessed claim for assessed listed and registered complementary medicines
12 Jun 2019: The TGA has implemented a TGA assessed claim for assessed listed medicines and registered complementary medicines.
- FAQs on issues raised by industry in relation to permitted indications
12 Jun 2019: We have published a list of frequently asked questions and answers on our website to assist sponsors understand the regulatory requirements for permitted indications.
- Update to the list of permitted indications for listed medicines
15 Feb 2019: Upcoming changes to the Changes to the Permissible Indication Therapeutic Goods (Permissible Indications) Determination have been published for the information of stakeholders.
- Evidence guidelines
1 Feb 2019: The Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines have been reviewed to incorporate changes to the regulatory framework for listed medicines arising from amendments to the Act that were effective 6 March 2018.
- Listed medicine compliance rating scheme
28 Nov 2018: A rating scheme has been introduced as part of the compliance review process to provide a standardised approach to rating the compliance of listed medicines according to risk
- Outcomes: Options for the implementation of a claimer for efficacy assessed non-prescription medicines
24 Sep 2018: Consultation outcomes published
- Outcomes of the consultation on the draft list of permitted indications
6 May 2018: Indications available for use for listed medicines are now contained in a 'list of permitted indications' which is contained in the Therapeutic Goods (Permissible Indications) Determination
- Changes to evaluation of substances for use in listed complementary medicines
3 May 2018: The TGA has introduced new application categories and legislated timeframes for evaluation of substances for use in listed complementary medicines.
- Assessed listed medicines pathway for complementary medicines
27 Mar 2018: The TGA has implemented a new assessed listed medicines pathway under section 26AE of the Therapeutic Goods Act 1989 (the Act)
- Permitted indications for listed medicines
7 Mar 2018: The TGA has implemented a list of permitted indications for medicines listed under Section 26A of the Therapeutic Goods Act 1989 (the Act)
- Submissions received and TGA response: Business process improvements supporting complementary medicines assessment pathways
25 Jan 2018: Consultation outcomes published