Literature-based submissions for complementary medicines

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ARGCM Part A: General guidance on complementary medicine regulation in Australia

29 October 2017

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 submissions

Our complementary medicine 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 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.

Conducting the literature search

There is no single search strategy that can be applied in all cases. Whatever methodology you use, ensure that you:

  • clearly explain and justify that methodology in the application
  • include full details of the search methodology used to obtain the data supporting the application

There may be instances (i.e. literature on traditional preparations) where literature based on a non-systematic review of the literature as outlined in Literature based submissions not based on a systematic search of the literature are appropriate. However, justification for providing this type of review rather than a systematic review of the literature is required.

Scope of the literature search

Chemical identification and constituents

  • Identify as many descriptors as possible for the substance and use them when you retrieve relevant literature for both traditional use and scientific evidence. Ensure you include generic names (where relevant) and trade names, traditional names, botanical terminology and Chemical Abstracts Service (CAS) registry numbers
  • For botanicals, or substances where there may be multiple constituents, search the terms for the constituents (e.g. in the case of Zingiber officinale, search terms such as zingiber, ginger, zingerols, and zingiberenes)
  • Where several different terms are used (either for substances or constituents), there should be clear evidence of where terms refer to the same entity (e.g. shosaikoto (Japanese) is xiao chai hu tang (Chinese Pin Yin), and both are called 'Minor bupleurum decoction' in the Chinese literature). Similarly, there should be evidence of chemical identity (e.g. CAS registry numbers should be consistent across different records)
  • Include details of where and how you established the terminology (this search is non-systematic)

Literature on traditional use

Where possible provide evidence from both databases and print sources. This type of search is usually a non-systematic search as it is does not need to be based on an extensive search of all the literature. Sources for such literature include:

  • pharmacopoeias (which may be national or international)
  • current and/or classical references in the specific field under review (e.g. herbal or homoeopathic pharmacopoeias or Materia medica)
  • standard works on the ethnobotany, or use of medicinal plants in a geographic area/
  • databases of biological literature (such as BIOSIS or CAB Abstracts)

Include details of where and how you sourced the evidence. Ensure you include a summary of the references retrieved, ideally in a table format with full bibliographic citations. Provide full copies of the references.

Further considerations for using traditional evidence

Traditional evidence may be used to support an application for a registered complementary medicine when there is a clear history of use as a medicinal or food substance. Usually a traditional substance with a well-established[2] history of use will have information published in official pharmacopoeias and other published literature. It is essential that this literature demonstrates:

  • traditional indications are based on evidence of a history of medicinal use that meets or exceeds three generations (75 years) of use
  • that the proposed medicine is consistent with the traditional preparation and the traditional use (including dose, route of administration and duration of use)
  • the population and culture in which this tradition occurred must be identified
  • in some cases, evidence of traditional use, for examples: aboriginal bush remedies, would require robust anthropological research data due to limited published/documented data

It can be difficult to establish the safety and/or efficacy of a RCM based solely on traditional and anecdotal evidence However, it may be used in combination with study reports or additional literature. If your application is to rely on traditional use to support safety or efficacy please arrange a pre-submission meeting to discuss the suitability of the evidence.

NOTE: Modern extraction methods or other processes may produce, in some cases, substances that have a considerably different compositional profile from those produced using traditional methodology. For examples: modern highly concentrated Acetea racemosa (black cohosh) herbal extracts have been linked with serious adverse reactions that have not been reported from traditional extracts. In some instances, the extraction of a substance from its natural matrix may make it more prone to oxidation to a toxic product or to inactivation, for example: carotenoids or resveratrol.


Footnote

  1. Well established use means that a sufficient number of people were treated or exposed to the medicine or food over a period sufficient to support the safety or efficacy for its intended purpose.