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Data Protection Scheme for assessed listed medicines

Guidance
Last updated

The TGA has implemented a Data Protection Scheme (the Scheme) for assessed listed [L(A)] medicines. This Scheme was developed in response to Recommendation 50 of the Medicines and Medical Devices Regulation (MMDR) review and is enabled under section 26AF of the Therapeutic Goods Act 1989.

The purpose of the Scheme is to:

  • Incentivise innovation by protecting the results of investment in the development of new works and technology.
  • Prevent competitors seeking market authorisation of generic forms of an L(A) medicine by preventing competitors from relying on clinical trials that were generated and used by the sponsor of the originator medicine to obtain market authorisation.
  • Encourage further research and development activities by preventing others from capitalising on a sponsor's investment and innovation.
  • Scope of guidance document
  • Overview of the Data Protection Scheme
    • Purpose
    • About the Scheme
    • Assessed listed [L(A)] medicines
    • Data eligible for protection
    • Criteria for data protection
    • Data protection period
  • New intermediate indications
    • Definition of an intermediate indication
    • Structure of an intermediate indication
    • When an intermediate indication is considered new
  • How the Scheme works
    • Information must not be available to the public
    • Sponsors must provide raw clinical trial efficacy data and the full clinical trial study report
    • The sponsor must own the information
    • Sponsors must provide the unique clinical trial registry number
    • Sponsors must identify the new intermediate indication-active ingredient(s) combination relating to data protection
    • Subsequent applications using the same intermediate indication-active ingredient(s) combination
    • Sponsors must notify the TGA of publication details
    • The TGA's responsibilities
    • Literature-based submissions are not eligible for data protection
    • Clinical trial registries
    • How to submit an L(A) medicine application and make a restricted information certification
  • Appendix 1
    • Completing the CTD Module 1.5 - Assessed listed medicines - Restricted information certification
    • Part A - Reliance on restricted information declaration
    • Part B - Eligibility for information to be restricted
    • Accessing help
  • Version history

Supporting documents

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This webpage on the TGA website was printed on 14 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/guidance/data-protection-scheme-assessed-listed-medicines

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