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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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8. Products with a 'new' dosage form

Applications for products containing active ingredients that have not previously been included in the proposed dosage form will generally require full clinical data. However, where the originator and new product are both immediate release oral dosage forms (e.g. a tablet, capsule, oral liquid or suspension), the TGA will accept applications to register the ‘new’ product without clinical data on the basis of data that demonstrate that the ‘new’ and ‘originator’ products are bioequivalent, or a justification that bioequivalence data are not required (refer to 'Section 6.1 Bioequivalence data'), provided the following apply:

  • there is no reason to consider that safety and efficacy properties would differ; and
  • the indications and dosage regimen are the same as those of the ‘originator’ product; and
  • the clinical data provided with the ‘originator’ product are not ‘protected’ (Section 25A of the Act refers).

Where a ‘new’ dosage form has sustained release characteristics, the guideline as set out in 'Section 10 Modified release products' should be followed.

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