Australian Therapeutic Goods Administration reviewing human cell and tissue legislative instruments

The Therapeutic Goods Administration (TGA) is conducting a public consultation seeking feedback on a proposal to remake some of the legislative instruments and associated guidance documents relating to human cell and tissue (HCT) products (including blood and blood components), which sunset in October 2021. Feedback has been sought from stake to make sure the proposed changes improve clarity on technical requirements, ensure alignment with international best practice and standards and bring legislation into alignment with recent amendments, including updates to autologous HCT requirements.

Developments can be followed at: https://consultations.health.gov.au/tga/consultations-health-gov-au-tga-remake-tgos-hct-bl/