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The Therapeutic Goods Administration (TGA) hosted the second meeting of the Women’s Health Products Working Group on 20 October 2022. The meeting was attended by special guest the Hon Ged Kearney, Assistant Minister for Health and Aged Care.
The Working Group comprises of 12 members with various professional backgrounds, including health professionals, academia and patient groups, and aims to progress further enhancements to the medicines and medical devices regulatory frameworks in Australia.
The following topics were discussed:
- Medical Abortion; including currently listed drugs, rural and remote access, and training of healthcare workers for prescribing and dispensing. The discussion also covered current risk management plans, product and consumer information and patient follow-up, as well as the regulation requirements, funding and Pharmaceutical Benefit Scheme (PBS) access.
- Transvaginal mesh and access issues for persons requiring sacrocolpopexy and the Special Access Scheme (SAS).
- US Food and Drug Administration (FDA) warning regarding reports of squamous cell carcinoma (SSC) and other lymphomas found in the capsule around breast implants.
- Data collection, including the role of registries in ensuring quality collection of real-world evidence, how the TGA uses information from the joint and breast implant registries and future plans associated with the pelvic floor registry.
- Independent review relating to the regulation of medical practitioners who perform cosmetic surgery, including TGA’s role in the regulation of devices used in both surgical and non-surgical cosmetic procedures.
Members discussed ways the TGA could frequently share information on trends, outcomes, or other information relating women’s health and upcoming consultations.
The next meeting is scheduled to be held in Melbourne in March 2023.