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ARGOM Appendix 1: Guidelines on efficacy and safety aspects of OTC applications

Version 1.0

29 November 2015

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The Therapeutic Goods Act 1989 (the Act) requires that applications for a product registration be evaluated "having regard to whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established".

All applications for over-the-counter (OTC) medicine registration must be supported by evidence to substantiate the safety and efficacy of the product. This part of the guidance document describes the types of evidence that should be submitted for the various OTC medicine applications. It is divided into eleven sections as follows:

  1. Standard reference texts
  2. Literature-based submissions
  3. Clinical trials on the proposed product
  4. Preclinical studies
  5. Post-market experience
  6. 'Generic' products
  7. Product specific requirements
  8. Products with a 'new' dosage form
  9. Fixed combination products
  10. Modified release products
  11. Active ingredients for which bioequivalence data are generally not required

In some cases, where safety and efficacy of the proposed product are well established in Australia and bioequivalence data are not required, provision of supporting evidence to the TGA may not be necessary (see 'Section 6.1 Data requirements'). Deviations from these guidelines may be accepted provided sound justification is given.

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