Open Consultations and Surveys

4 results

  • Consultation: Legislating regulatory categories for some boundary and combination products

    The Australian Government is undertaking significant reforms to further improve regulation of therapeutic goods in Australia. The Therapeutic Goods Administration (TGA) is the government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods including medicines, medical devices and biologicals. Products that meet the legislative definition of a therapeutic good under the Therapeutic Goods Act 1989 (the Act) are regulated... More
    Closes 6 August 2024
  • Consultation on a proposed exposure model for assessing the safety of sunscreen ingredients in Australia

    The Therapeutic Goods Administration (TGA) is seeking public comment on proposed models to estimate sunscreen use (exposure) by Australians which will be used to calculate the maximum safe concentration of sunscreen ingredients. The options proposed for stakeholder consideration include: Option 1: Australian Sunscreen Exposure Model (ASEM) The ASEM calculates the highest estimated daily sunscreen exposure, by integrating expected sunscreen... More
    Closes 13 August 2024
  • Reforming Australia's Therapeutic Goods Testing Regulations

    The Therapeutic Goods Administration (TGA) is responsible for protecting the health and safety of the community by regulating therapeutic goods for safety, efficacy, performance, and quality. We do this through the application of the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods Regulations 1990 (the Regulations) and associated legislation. The TGA Laboratories are responsible for delivering results on the quality and performance of therapeutic goods. The testing... More
    Closes 18 August 2024
  • Consultation on the sunsetting Therapeutic Goods Order No.70C - Standards for Export Only Medicine

    Therapeutic Goods Order No. TGO 70C (TGO 70C) – Standards for Export Only Medicine ( https://www.legislation.gov.au/F2014L00683/asmade/text ) is a relevant standard for therapeutic goods which are listed for export only in the Australian Register of Therapeutic Goods (ARTG). TGO 70C is due to sunset on 1 October 2024. The Therapeutic Goods Administration (TGA) Export Unit as part of the Prescription Medicines Authorisation Branch (PMAB) is reviewing the sunsetting TGO with the intention... More
    Closes 26 August 2024
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