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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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3. Clinical trials on the proposed product

In circumstances where safety and efficacy data are required but neither standard references nor a literature-based submission are appropriate, it will be necessary to provide reports of clinical trials that the sponsor has conducted to establish the safety and efficacy of the product proposed for registration.

Clinical data should preferably be presented as specified in Modules 2.5 Clinical Overview, 2.7 Clinical Summary and Module 5 Clinical Study Reports of the CTD format. The clinical overview is intended to provide a critical analysis of the clinical data in the dossier while the clinical summary is intended to provide a detailed, factual summarisation of all of the clinical information provided.

The following relevant European Guidelines developed by the Committee for Medicinal Products for Human Use (CPMP) have been adopted by the TGA (with annotations) and can be found on the TGA website.

  • Note for Guidance on Coordinating Investigator Signature of Clinical Study Reports (CPMP/EWP/2747/00)
  • Note for Guidance on Good Clinical Practice - annotated with TGA comments (CPMP/ICH/135/95)
  • Note for Guidance on Structure and Content of Clinical Study Reports (CPMP/ICH/137/95)
  • Note for Guidance on General Considerations for Clinical Trials (CPMP/ICH/291/95)
  • Note for Guidance on Statistical Principles for Clinical Trials (CPMP/ICH/363/96)
  • Note for Guidance on Choice of Control Groups in Clinical Trials (CPMP/ICH/364/96)
  • Clinical Overview, Clinical Summary of Module 2 and Module 5: Clinical Study Reports (CPMP/ICH/2887/99/Rev 1 Efficacy)
  • Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev 1)(adopted by TGA with additional notation)
  • Clinical requirements for locally applied, locally acting products containing known constituents (pp. 193 - 198 of Rules 1998 (3C) - 3CC12a)
  • General Questions and Answers. Common technical document for the registration of pharmaceuticals for human use (CPMP/ICH/5552/02)

Other CPMP guidelines may be relevant to particular applications. Details of all CPMP guidelines adopted by the TGA can be found on the TGA website.

3.1 Good clinical practice (GCP)

The TGA requires that all phases of clinical investigation be conducted in accordance with acceptable guidelines for Good Clinical Practice (GCP). The Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95 - Annotated with TGA comments) should be referred to. A statement regarding GCP compliance should be included in the Clinical Overview (Module 2.5 of the CTD format) or the study report.

3.2 Ethical certification

The Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95 - Annotated with TGA Comments) states that "Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s)." For trials conducted in Australia applicable regulatory requirements include the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Research Involving Humans. The sponsor must be able to provide the TGA with any relevant documentation, including approval letters from Human Research Ethics Committees (HRECs), specimen subject consent forms and patient information sheets if requested.

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