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General information for consumers on prescription opioids

Therapeutic Goods (Declared Goods) Order 2019 consolidates and replaces several instruments

Japan has recently been added to the list of Foreign Countries and Jurisdictions determined to be comparable overseas regulators

International Collaborative Review Initiative gives provisional approval of lenvatinib in combination with pembrolizumab

The Federal Court has imposed substantial penalties on Peptide Clinics Australia

TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98

The prescription medicines regulatory reforms include changes that will bring medicines to market sooner in Australia, while maintaining a robust framework for safety, quality and efficacy.

Cabozantinib (CABOMETYX) is the first medicine to be registered via the new COR-A pathway

Apalutamide (Erlyand) is the first medicine approved via ACSS Consortium’s NCE working group

This instrument applies to an application to list a complementary medicine under section 26AE of the Act.

This instrument applies to an application to list a medicine under section 26 or 26A of the Act.

This instrument applies to an application to register a complementary medicine

Therapeutic Goods (Provisional Determinations and Orphan Drug Designations-Extension) Approval of Application Form.

This instrument applies to the online form titled Prescription Medicines Designation/Determination Application in the TGA's electronic lodgement facility, completed in accordance with the relevant instructions in that form.

s23 instruments supporting the new COR process have been updated.

s23 instruments supporting the new COR process have been updated.

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.