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Australian clinical trial handbook
Guidance on conducting clinical trials in Australia using 'unapproved' therapeutic goods
Importing and exporting
Import and export restrictions for therapeutic goods
Restrictions may be placed on the import and export of therapeutic goods for clinical trials. Some of these restrictions have been outlined below (this list is not exhaustive). Information regarding permit requirements can be found at the links provided below. Given the time required to assess applications, it would be advisable to submit permit applications early in the clinical trial planning process:
- Therapeutic goods legislation (see below)
- Customs (Prohibited Imports) Regulations 1956 and Customs (Prohibited Exports) Regulations 1958 - a licence and or permit to import or export may be required for substances controlled under this legislation
- Biosecurity Act 2015 - permission may be required prior to importing any material of biological origin (human, animal, plant or microbial)
- Environment Protection and Biodiversity Conservation Act 1999 - permission may be required prior to importing endangered species
- Gene Technology Act 2000 - permission may be required prior to importing genetically modified organisms
- State and territory requirements (contact the relevant state or territory department of health)
- Requirements of the legislation of the originator or destination country
Importing therapeutic goods for use in clinical trials in Australia
The Therapeutic Goods Act 1989 prohibits import into or supply in Australia of 'unapproved' therapeutic goods for use in humans unless they are included in the ARTG or otherwise the subject of an exemption, approval or authority.
Item 1 of Schedule 5A to the Therapeutic Goods Regulations 1990 and item 2.1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 provide an exemption for therapeutic goods to be imported and held prior to supply in a clinical trial subject to conditions.
The imported therapeutic goods must be held under the direct control of the sponsor (importer) until the goods are the subject of a notification under the CTN scheme or an approval under the CTX scheme. Until such time, the goods must be kept in a warehouse or a properly secured area under the control of the importer in accordance with the relevant exemption.
There is no requirement for the CTN or CTX process to have been completed prior to importation of the clinical trial goods. However, approval through the CTX scheme or notification through the CTN scheme needs to have occurred prior to supply of the goods to the trial sites.
Other conditions relevant to the exemption include keeping records relating to the source and supply of the goods. These records should be provided to us if requested.
This text representation of this flowchart is provided as a list with numbered steps.
- Sponsor (importer):
- Checks import restrictions and applies for any relevant permissions.
- Imports clinical trial goods into Australia, under item 1 of schedule 5a of the regulations.
- Holds clinical trial goods under direct control, under item 1 of schedule 5a of the regulations.
- Supplies goods to trial sponsor under CTN exemption or CTX approval.
- Clinical trial sponsor.
- Supplies therapeutic goods to participants in clinical trial, subject to HREC and institutional authorisations.
- End flowchart.
Exporting therapeutic goods for use in clinical trials overseas
We are responsible for granting approvals for the exportation from Australia, or importation to Australia and subsequent exportation of specified 'unapproved' therapeutic goods for use overseas solely for experimental purposes in humans under sections 19(1)(b), 32CK(1) and 41HB(1) of the Therapeutic Goods Act 1989.
Approvals are required for the following scenarios:
- Importation for subsequent exportation to clinical trial sites in specified countries
- Importation for subsequent exportation to a distribution centre
- Exportation only to clinical trial sites in specified countries
- Exportation only to a distribution centre
Approvals are usually issued for the duration of twelve months for multiple consignments, for distribution to the country(s) specified in the approval. An approval is subject to any conditions that are set out in the approval or imposed under the therapeutic goods legislation. One of the conditions of approval under the Therapeutic Goods Regulations 1990 is that a report detailing the quantity of goods that have been exported to each clinical trial site must be submitted to us every six months.
The application form is available at Import/export of 'unapproved' therapeutic goods for experimental purposes. This form also provides information on the documents to be submitted with the form.
A specific export permit for human blood and tissue is required under the Customs (Prohibited Exports) Regulations 1958, unless the immediate container is of a volume of 50ml or less. Further information can be found at Export of human blood/tissue and related materials (including bodies & cremated remains).
Six monthly reports
A sponsor of therapeutic goods in relation to an exemption under section 18, 32CA or 41HA or approval under section 19, 32CK or 41HB of the Therapeutic Goods Act 1989 must provide a report to us every six months. Regulation 47B of the Therapeutic Goods Regulations 1990 outlines the details required in such reports.
Retrieval, destruction and export of unused clinical trial material
The Guideline for Good Clinical Practice outlines that trial sponsors need to maintain a system for the retrieval and disposition of investigational product(s) and for the documentation of this disposition.
There are provisions under the therapeutic goods legislation that allow the export of therapeutic goods for destruction. Under item 2 of Schedule 5 to the Therapeutic Goods Regulations 1990 and item 1.2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 'unapproved' therapeutic goods may be exported from Australia if they:
- are not for commercial supply; and
- do not contain a substance the exportation of which is prohibited under the Customs Act 1901; and
- are not intended for use in clinical trials on humans.
Therefore, if the above conditions apply then the goods may be exported for destruction without any requirement for export approval from us. The Office of Drug Control provides advice on substances that may be prohibited exports.
Trial sponsors are also advised to contact the relevant department in the destination country to determine requirements.