Australian regulators for registering do not distinguish between complementary medicines and other pharmaceuticals concerning the safety, efficacy, and quality of the product, including the imported ones!
To register herbal, animal, cosmetics, vitamins, or mineral products in Australia, one needs to take the route of the Complementary registration process.
Read the first part of this series – Regulatory Approval for Complementary Medicines in Australia Part-I – to understand what complementary medicines are and how they are classified in Australia.
If you are interested in filing an application for your complementary medicine in Australia, let’s understand how TGA ensures the safety, quality, and efficacy of complementary medicine.
TGA regulatory approval process for complementary medicine
The whole process needs to be considered in these six parts before making a product application to TGA.
- Active ingredient
- Therapeutic claim
- Quality of the finished product
- Safety data
- Label and Advertisement of the product
- Australian based Sponsor
Let’s understand them one by one.
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1. Active ingredient
The sponsor needs to ascertain first, whether their active ingredients (active and non-active) are listed on the TGA website for the permissible active ingredient list.
The 26BB Legislative Instrument provides a list (26BB list) of all ingredients available for use in listed medicines.
If the active ingredient is registered on the 26BB list, it is fairly easy for the manufacturer to proceed with the listing or registration of such products, provided he complies with other TGA requirements for registration of such products.
If the active ingredient is not available on this list, it is treated as New Substance by TGA and the applicant has to start the process from registration of the active ingredient. A comprehensive dossier needs to be prepared and submitted to TGA for the evaluation of active ingredients.
Classification of ingredient evaluation
There are four different categories for the evaluation of active ingredients by TGA.
|IN1||Evaluation of safety and quality based on evaluation reports from a COB.|
|IN2||Evaluation of safety based on evaluation reports from a COB.|
Independent evaluation of quality by the TGA.
|IN3||Evaluation of quality based on evaluation reports from a COB; or a monograph contained in a default standard.|
Independent evaluation of safety by the TGA.
|IN4||Full independent evaluation of safety and quality by the TGA.|
Legend: (COR = comparable overseas regulator)
Based on the safety and quality data available along with regulatory filing status in other regions, sponsors can decide upon the category under which they would like to apply to TGA.
2. Therapeutic claim
- TGA Website provides a list of the permissible indications for use for listed complementary medicines.
- It is a legal requirement that the sponsor of the product holds acceptable evidence to support the product’s therapeutic claim.
- Evidence can be based on traditional use or scientific evidence.
- The sponsor has to prepare a bibliography/summary table of the evidence and references that support your product’s indications for use while applying to TGA.
- If your product is chosen by TGA for full evaluation (TGA does not fully evaluate all products, but select some), for the post-marketing product assessment, the sponsor has to provide a bibliography/summary table of the evidence you have used to support the therapeutic claim/ indications.
3. Quality of the finished product
Two main points need to be considered when it comes to managing the quality of the finished product.
- How is it manufactured (GMP aspect)?
- What are quality control measures in place?
TGA does not specify any GMP requirements for active ingredients. It’s only for finished products.
- The Australian Code of GMP is entirely based on the international standard Guide to Good Manufacturing Practices for Medicinal Products, published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S).
- Each Australian manufacturer of medicinal products for human use holds a manufacturing license.
- General information for manufacturers is provided on the TGA website for Australian manufacturing licenses and overseas GMP certification.
- All complementary medicine supplied in Australia must be manufactured in a facility that has been inspected for compliance with medicinal GMP.
- Australia has a Mutual Recognition Agreement (MRA) with some countries. However, if your products are not manufactured in one of these countries, then the TGA may need to visit the factory and perform an inspection for GMP compliance unless they have been inspected by a regulator recognized by the TGA, in which case an off-site documentation audit would be undertaken.
Quality control measures
The Act defines the quality standards applicable to all therapeutic goods.
- To ensure the quality of the product, the sponsor must ensure that they adhere to default standards recognized in the Therapeutic Goods Act 1989, that is, the British Pharmacopoeia, United States Pharmacopoeia – National Formulary, and the European Pharmacopoeia.
- If the ingredient is subject to a default standard, you have to comply with the applicable standard.
- The TGA considers the suitability of other national or international pharmacopoeial monographs or standards for a substance on a case-by-case basis.
- In many instances, there are no applicable monographs, in such cases, compositional guidelines must be developed by the sponsor.
- A compositional guideline is a summary of descriptions, tests, and limits that defines the composition and relevant characteristics of the substance, where the pharmacopoeial monograph or standard sufficiently characterizes the substance, is not available.
4. Safety Data
Complementary medicine in Australia is classified based on the risk associated with the ingredient.
The sponsor must provide sufficient information on
- Literature search data,
- Toxicological data,
- Biological activity data,
- Clinical trial data and
- Adverse reaction
to prove the safety and efficacy of the product
If the product is derived from an animal source or human source, the sponsor may have to support the dossier with additional safety data.
Do you know that QUALITY & SAFETY are the two most important considerations for TGA? Ascertain that your filing matches the criteria.
The way forward to effective dossier preparation
It’s imperative for sponsors to make a comprehensive dossier for their product and submit it to TGA.
With all supportive evidence, particularly those related to quality and safety, your dossier stands strong for a thorough evaluation by TGA.
There are two other important aspects of the dossier – Label & advertisement sponsor – that need to be considered to make the dossier complete in all aspects.
It’s a long wait for approval after dossier submission to TGA based on the category you have chosen for your product. The last thing you want from TGA after this waiting period is a query (or, queries), which can cost you costly delays in the product launch.
So be cautious.
We will be covering up the remaining important aspects and salient features for a flawless submission process, along with post-marketing review and adverse event reporting aspects in the last and concluding part of this series.
Stay tuned for part III in this series.
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