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Australian Export Controls and the Life Sciences

A guide to understanding export control laws regarding the physical export, intangible supply, publication or brokering of life sciences related goods, software or technology

Annex 3: Technology Readiness Levels

Technology Readiness Levels are a way of determining the maturity of technology as it moves through its lifecycle from research and development through to production and deployment. Technology Readiness Levels are based on a scale from 1 to 9 with 9 being the most mature technology.

Technology Readiness Level Description Permit Required
Research and Development

1

Review of Scientific Knowledge Base

  • Research at this level would be “Basic Scientific Research”.
  • The export or supply of technology would not require a permit.

No

2

Development of Hypotheses and Experimental Designs

  • Research at this level would be “Basic Scientific Research”.
  • The export or supply of technology would not require a permit.

No

3

Target/Candidate Identification and Characterisation of Preliminary Candidate(s)

  • Research at this level may no longer be “Basic Scientific Research”.
  • The export or supply of technology may require a permit.

Maybe

Testing and Demonstration

4

Candidate Optimisation and Non-Good Laboratory Practice In Vivo Demonstration of Activity and Efficacy

  • Research at this level could be “Basic Scientific Research”, but may be closer to applied research.
  • A permit may be needed for technology that is deemed “required” and is not “basic scientific research”.

Maybe

5

Advanced Characterisation of Candidate and Initiation of Good Manufacturing Practice (GMP) Process Development

  • Research at this level would usually be applied or experimental research.
  • A permit may be required for the supply of technology and the export of any goods and technology.

Yes
(if no exemptions apply)

6

GMP Pilot Lot Production, Therapeutics Goods Administration Registration, and Phase 1 Clinical Trial(s)

  • Research at this level would usually be applied or experimental research.
  • A permit may be required for the supply of technology and the export of any goods and technology.

Yes
(if no exemptions apply)

Production and Deployment

7

Scale-up, Initiation of Good Manufacturing Practice Process Validation, and Phase 2 Clinical Trial(s)

  • Research at this level would usually be applied or experimental research.
  • A permit may be required for the supply of technology and the export of any goods and technology.

Yes
(if no exemptions apply)

8

Completion of GMP Validation and Consistency Lot Manufacturing, Pivotal Animal Efficacy Studies or Clinical Trials, and TGA registration of good

  • Research at this level would usually be applied or experimental research.
  • A permit may be required for the supply of technology and the export of any goods and technology.

Yes
(if no exemptions apply)

9

Post-Licensure and Post-Approval Activities

  • Research at this level would usually be applied or experimental research.
  • A permit may be required for the supply of technology and the export of any goods and technology.

Yes
(if no exemptions apply)

Previous: Annex 2: Definitions used in this guide Next: Annex 4: Notes in the DSGL that apply to controlled items