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711 result(s) found, displaying 1 to 25
- Meeting statementsWomen’s Health Products Working Group meeting #3, 27 March 2023Communique from the 3rd meeting of the Women's Health Products Working Group (WHPWG), 27 March 2023
- PublicationsUse of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)Insertion of links to legislative instruments and related notations.
- Meeting statementsACM meeting statement, Meeting 36, 1-2 December 2022Advisory Committee on Medicines meeting statement
- Meeting statementsACM meeting statement, Meeting 37, 3 February 2023Advisory Committee on Medicines meeting statement
- Meeting statementsACM meeting statement, Meeting 38, 30-31 March 2023Advisory Committee on Medicines meeting statement
- Meeting statementsACM meeting statement, Out of Session Meeting, 10 November 2022Advisory Committee on Medicines meeting statement
- Meeting statementsACMD meeting statement, Meeting 72, 13 April 2023Meeting statement from the Advisory Committee on Medical Devices (ACMD), 13 April 2023.
- PublicationsAccess Consortium offers pipeline meetings to pharmaceutical and biotechnology companiesThe Access Consortium is offering joint pipeline meetings to pharmaceutical and biotechnology companies.
- Meeting statementsMedical device reforms: Consumer Working Group meeting statement, Meeting 10, 14 March 2023Meeting statement from meeting 10 of the MDCWG.
- Scheduling decisions (final)Notice of final decision to amend (or not amend) the current Poisons Standard - ACMS #40, ACCS #34, Joint ACMS-ACCS #32Public notice of final decision to amend (or not amend) the current Poisons Standard - ACMS #40, ACCS #34, Joint ACMS-ACCS #32
- Scheduling submissionsPublic submissions on interim decisions for scheduling matters referred to the ACMS #40, ACCS #35 and Joint ACMS-ACCS #32Public submissions on interim decisions for scheduling matters referred to the ACMS #40, ACCS #35 and Joint ACMS-ACCS #32 meetings held in November 2022
- TGA laboratory testing reportsTesting of nicotine vaping productsTest results of compliance testing against TGO110 of available and imported nicotine vaping products are now published on the TGA website.
- PublicationsClinical performance requirements and risk mitigation strategies for HIV testsGuidance for manufacturers and sponsors of HIV tests on meeting regulatory requirements and expectations.
- Meeting statementsACV meeting statement, Meeting 39, 7 December 2022Advisory Committee on Vaccines meeting statement
- PublicationsTGA stakeholder surveysWe survey our stakeholders each year to help evaluate our performance and identify ways of improving.
- Meeting statementsACCM meeting statement, Meeting 30, 3 November 2022Advisory Committee on Complementary Medicines meeting statement for 3 November 2022
- PublicationsTherapeutic Goods Advertising and Compliance Education Plan 2023This plan outlines the compliance and education priorities of the Therapeutic Goods Administration for 2023.
- Meeting statementsACMD meeting statement, Meeting 71, 9 February 2023Meeting statement from the Advisory Committee on Medical Devices (ACMD), 9 February 2023.
- PublicationsAdverse drug reaction reporting using Best Practice: Using the ADR reporting templateHow to use the ADR reporting template in the Best Practice software
- PublicationsTherapeutic Goods Advertising Compliance Education StrategyThe strategy outlines the approach the TGA will use to identify, engage with, and educate stakeholders about advertising requirements.
- PublicationsAction Plan for Medical Devices - Progress Report Card: December 2022The report cards show the progress made by the TGA in the 3 strategies that make up the Action Plan for Medical Devices.
- PublicationsMedical devices reforms: An Action Plan for Medical DevicesThe Action Plan will further improve Australia’s medical device regulatory system and place patient safety first.
- PublicationsOTC N2 applications and OTC medicine monographsN2 applications involve reduced requirements for data assessment by the TGA and consequently shorter evaluation timelines.
- Meeting statementsMedical device reforms: Consumer Working Group meeting statement, Meeting 9, 9 December 2022Meeting statement from meeting 9 of the MDCWG.
- Scheduling decisions (final)Notice of final decision to amend (or not amend) the current Poisons Standard - June 2022 ACMS #38 - Psilocybine and MDMAPublic notice of final decisions to amend (or not amend) the Poisons Standard - ACMS, June 2022