In its response to the Sansom review of Australian regulation, TGA signalled its intent to accept the recommendations to streamline arrangements for special access to unapproved medicines and medical devices.
TGA announced today it has updated the administrative arrangements to remove the requirement for applicants to file clinical justifications with Authorized Prescriber applications (as this has already been reviewed by an ethics committee or professional college). The TGA announcement also provides for discretionary extension of the duration of approvals: up from one year to two years for medical devices and from two years to five years for medicines and biologicals.
TGA has also introduced a new Special Access C pathway which provides for health care practitioners to provide certain specified therapeutic goods to users without first requiring an authorisation from TGA. The practitioner then has to submit a notification to TGA within 28 days. This pathway was developed in response to the Sansom review recommendation to streamline special access for defined goods with established history of use when supplied for specified indications. TGA has published Legislative Instruments (Rules) which specify the goods within scope of Special Access C. There are separate orders for medicines, biologicals and medical devices.
See full details, forms and guidances at TGA’s website.
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