Resources

How to demonstrate that IVF solutions comply with the Essential Principles for safety and performance.

Guidance on European Union guidelines for complementary medicine sponsors in Australia.

EMA/CHMP/ICH/308817/2008 adopted by the Therapeutic Goods Administration (TGA)

CPMP/ICH/295/95 adopted by the Therapeutic Goods Administration (TGA)

EMA/CHMP/BWP/133540/2017 adopted by the Therapeutic Goods Administration (TGA)

EMA/618604/2008 adopted by the Therapeutic Goods Administration (TGA)

Alerts

How to install the ADR reporting template in the Best Practice software

Installing the ADR reporting template in the Medical Director software

Using the ADR reporting template in the Medical Director software

Complying with therapeutic goods advertising restrictions.

External evaluators are required to use their expertise to review the data provided by sponsors and prepare an assessment report.

describes the minimum approach considered to be acceptable to achieve validation of the test procedures used for complementary medicines (products) and starting materials for use in complementary medicines

Online application form to become an Australian Conformity Assessment Body

Information and links to the application to import or export a therapeutic good that is mercury form.

The Australian Code of Good Manufacturing Practice (GMP) for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products (the Code) applies to Blood, Human Tissues and Human Cellular Therapy Products manufacturers that undertake the collection, processing, testing, storage, release for supply, and quality assurance of Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products.

A step-by-step guide for Australian manufacturers of therapeutic goods.

The ARGLMRCM presents guidance in separate documents to facilitate timely updates.

We have published updated guidance for OTC medicines to better assist applicants to register or make a change to a registered OTC medicine

This guide is for sponsors intending to use the priority review pathway for biologicals.

Application form to apply for biologicals (priority applicant) determination

This form is used to include a new biological or vary an existing biological on the ARTG

Use this form to report suspected adverse reactions to vaccines and prescription, over-the-counter and complementary medicines.

This checklist summarises key obligations for psychiatrists applying to prescribe and access MDMA and psilocybin under the Authorised Prescriber scheme.

This form is for sponsors to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA.