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OTC medicines - Safety and efficacy data

30 November 2015

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4 - Types of data to support OTC medicine applications

4.1 Literature-based submissions

If you do not have your own supportive data, but have published scientific literature you consider to be supportive of an application, you may opt for a literature based submission (LBS). Examples where this may be appropriate include the following types of applications:

  • changes to indications or label claims
  • changes to directions for use
  • changes to clinical or non-clinical aspects of the Product Information
  • new medicine applications (less common).

Mixed applications (part LBS, part complete study reports) may also be appropriate.

Requirements for literature-based OTC medicine submissions

Our OTC requirements for literature based submissions are essentially the same as for prescription medicines except that:

  • You do not need to consult or gain approval of LBS search strategies prior to submitting your application.
  • We do not have a formal pre-submission phase for OTC medicine applications.

You will need to conduct a systematic literature search for most literature based submissions, including those in support of new indications or label claims.

For further guidance on when an LBS may be suitable and what type of LBS to prepare, refer to the Pre-submission guidance for literature based submissions.

Standard reference texts

For some very old medicines where evidence from published studies is not available to be submitted, the use of standard reference texts such as the Handbook of Non-prescription Drugs (American Pharmacists Association, USA) may be acceptable as part of a LBS not based on a systematic search of the literature.

However, limited clinical reports of efficacy alone or anecdotal reports (e.g. in Martindale "xxx has also been used in ...") are not regarded as evidence of safety and efficacy.

If you are unsure of requirements, contact OTC Medicines.

Dossier requirements

Follow the guidance on dossier requirements for literature searches to compile your submission dossier.

Include any advice we give you about your literature search in Module 1.5.1 of the dossier.

4.2 Clinical trial reports

Provide full clinical trial reports where clinical data are required, unless providing a literature based submission.

Present clinical data as specified in the following CTD modules:

  • Modules 2.5 Clinical Overview - provides a critical analysis of the clinical data in the dossier
  • Module 2.7 Clinical Summary - provides a detailed, factual summary of all of the clinical information provided
  • Module 5 Clinical Study Reports.

Good clinical practice

Ensure that all phases of clinical investigation are conducted in accordance with Good Clinical Practice (GCP) guidelines. You will need to include a statement regarding GCP compliance in the Clinical Overview (Module 2.5 of the CTD).

Clinical trials information and guidance

We have adopted a large number of European Union (EU) clinical guidelines, some with annotations. Some key clinical guidelines adopted include:

Other clinical EU guidelines adopted in Australia that pertain to specific medicines, clinical aspects or study methodology may also be relevant to your application.

4.3 Non-clinical studies

Provide non-clinical studies for any of the following unless otherwise justified:

  • medicines with new ingredients (actives or excipients)
  • new fixed dose combinations
  • new routes of administration for an ingredient
  • higher doses of active or excipient ingredients, or use over a longer period of time, than currently approved. Contact OTC Medicines if you are unsure
  • medicines with impurity limits that are above those allowed without justification in the Guidelines on quality aspects of OTC Medicines.

Where there is a substantial history of use in comparable regulatory jurisdictions (e.g. UK, Canada, US), we may accept a justification based on safety-in-use substantiation from post-market information in place of non-clinical data.

ARGOM Appendix 4: Guidelines on OTC applications for new substances

4.4 Post-market information

Post-market information may provide further support for safety where aspects of the medicine are new to the Australian market but have been available for some time overseas. Examples may include applications for new:

  • active ingredients
  • fixed dose combinations
  • proposed indications
  • directions for use.

Where appropriate, include relevant post-market information as follows:

  • details of adverse medicine reaction reports from Australia and/or from relevant authorities in countries with similar regulatory systems to Australia
  • copies of relevant 'Periodic safety update reports' (PSURs).

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