Using literature based submissions for listed, assessed listed and registered complementary medicines

An applicant may opt to submit a literature based submission (LBS) where you do not have your own product- or ingredient- specific supportive data but hold published scientific literature you consider to be supportive of your application. 

This may be acceptable for: 

• compiling an evidence package to support indications made for a listed medicine- refer to Guidelines on the evidence required to support indications for listed complementary medicines 
• an application for the evaluation of a substance for use as a new ingredient in listed medicines 
• an application for evaluation of a new assessed listed medicine 
• an application for a new registered complementary medicine, under certain circumstances (less common) 
• an application for changes to the indications or label claims or directions for use for assessed listed medicines 
• an application for changes to registered complementary medicines, including changes to: 
  • indications or label claims 
  • directions for use 
  • clinical or non-clinical aspects of the Product Information. 

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

The requirements for literature based submissions for listed medicines and registered complementary medicines is the same 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.

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

• clearly explain and justify the methodology used 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, a justification for providing this type of review rather than a systematic review of the literature is required. 

Scope of the literature search 

Chemical identification, microbial taxonomy 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 micro-organisms, the following taxonomical information needs to be provided: genus, species and strain name/code. 
• 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-established¹ 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 

The establishment of the safety and/or efficacy of a registered complementary medicine (RCM) cannot be 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.

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.