Do you know that Australian complementary medicines are viewed as the consumer protection benchmark internationally?
Numerous complementary medicines are recognized as premium brands in Australia and internationally. The obvious reason being – Australia’s complementary medicines industry is proudly backed by a regulatory regime that is regarded as one of the strictest in the world!
With such high quality of these products, the Australian complementary medicines market has reached sales of $4.9 billion, which has doubled over the past 10 years. Over 60 percent of companies in this sector are engaged in exporting activities of their products.
Read through our previous blogs in this series, Regulatory approval for Complementary Medicines in Australia Part-I and Regulatory approval for Complementary Medicines in Australia Part-II to understand the regulations involved with the application of complementary medicines in Australia.
Continuing our discussion on the readiness of the sponsor to submit a comprehensive dossier to TGA, let’s understand the remaining points (Check the previous blog of this series for the first four points).
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5. Label and Advertisement of the product
- The product must be labeled in compliance with Australian labeling regulations.
- All product labels must contain a product AUST number on them.
- The sponsor needs to ensure that the marketing and advertising of therapeutic goods to consumers is conducted in a socially responsible manner that promotes the quality use of therapeutic goods and does not mislead or deceive the consumer.
- Advertising of therapeutic goods to the public must comply with the Therapeutic Goods Advertising Code.
- Advertisements to the general public for therapeutic goods appearing in mainstream media (e.g. newspapers, magazines, television, and radio) must be pre-approved before their publication or broadcast.
6. Australian based Sponsor
- Any therapeutic product supplied in Australia must be supplied by an “Australian Sponsor” as per the TGA requirement.
- For overseas clients, an Australian person or company should take legal responsibility for the application and be the official point of contact for TGA.
- The label of any medicine supplied in Australia must include the name and contact details of the Australian sponsor or distributor.
- Establishing understanding from these 6 key elements (the first four of them covered in our previous blog of this series), the sponsor can proceed with compiling the data for the comprehensive dossier and proceed with the submission to TGA.
It is advisable for sponsor to arrange a pre-submission meeting with TGA for submitting high quality complete dossier.
- Dossier needs to be presented with all data in the best possible format. TGA website provides the dossier format and has designed the modules in which they would like to receive the application. Check out this format of the dossier for registration of Complementary Medicines with TGA Australia here.
- If the application does not meet a specific technical requirement or does not adhere to an applicable guideline, a justification must be provided.
- Listed complementary medicines are included in the ARTG via an electronic application process that is designed to allow simple and fast access to the market for low-risk complementary medicines.
- TGA may come back to them and ask queries if they feel they need more supporting documents on a particular topic.
Remember, approval timelines vary based on the
- product category selected
- complexity of the dossier,
- evidence provided to support the claim,
- labeling of the final product,
- GMP certificates etc
If TGA feels that they need more information, they communicate to the applicant and provide justifiable time to the applicant to provide the necessary data.
For the period applicant is making provision of the data, TGA follows the stop clock mechanism.
TGA is in the process of developing a formal education program to provide sponsors with appropriate information and tools to assist them in understanding their obligations and enhance compliance, particularly with the reforms to advertising.
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The Regulatory Framework for Medicines in Australia
For monitoring the medicine in Australia and to ensure the safety, efficacy, and quality of the product, TGA follows below listed monitoring mechanisms:
- Licensing and Audit of Manufacturers units
- Pre Marketing assessments
- Post Marketing regulatory activity
1. Licensing and Audit of Manufacturers units
- The Act requires each Australian manufacturer of medicinal products for human use to hold a manufacturing license.
- TGA ensures compliance with Australian GMP by carrying out pre-licensing audits and regular on-site audit along with other GMP aspect which we have covered in the earlier blog of this series
2. Pre Marketing assessment
Based on the TGA classification of complementary medicines (listed/assessed listed/registered), TGA applies risk-based pre-marketing assessment procedures.
- Medicines that are assessed to be of higher risk are individually evaluated for quality, safety, and efficacy.
- Higher-risk products approved by the TGA are included on the ARTG as Registered medicines.
- Efficacy is usually assessed by examining data from controlled clinical trials for registered and assessed listed products.
- When adequate information is available on each active ingredient, and it is well described in standard textbooks/guidelines, it can be used to support efficacy.
- Listed products are considered as low-risk products and get marketed once TGA approves the product dossier
3. Post Marketing Monitoring
To maintain consumer confidence, TGA carries out post-market regulatory monitoring activities of listed and registered medicines once they are on the market.
Let’s understand how TGA conducts systemic risk-based post-marketing activity:
- targeted and random desk-based audits of Listed products;
- monitoring of adverse reactions to complementary medicines;
- targeted and random laboratory testing of products and ingredients;
- targeted and random surveillance in the marketplace;
- an effective, responsive and timely recalls procedure;
- effective controls for the advertising of therapeutic goods.
Post-market activities aims at identifying unsafe or potentially unsafe medicines and to take appropriate action to minimize the risk associated with their use.
Adverse Drug Reaction Reporting
An essential element of this approach is to monitor adverse reactions to medicines, including complementary medicines.
An adverse reaction reporting system for medicines in Australia is well established. The sponsors of all medicines included in the ARTG are under an obligation to report adverse reactions to the TGA.
All adverse reaction reports received by the TGA for complementary medicines are reviewed can lead to the following action.
- Further analysis of database reports investigating potential safety signals,
- Publication of a report in the Australian Adverse Drug Reactions Bulletin or medical journals to raise awareness of the reaction and/or
- Removal of the product from the market.
Various Australian complementary medicines brands are recognized and trusted internationally as the sector is well-established, having evolved over the last 30 years to become a world-class industry.
The Australian government is committed to foster a regulatory environment that is supportive of innovation, research, and high-skilled manufacturing. Ongoing regulatory reforms have set goals to minimize the regulatory and administrative burden for businesses, and ensuring timely access to quality therapeutic goods to consumers.
As a part of this commitment, the regulator has approved the use of many new activities and excipient ingredients for use in listed medicines, including 71 new ingredients in 2017.
With this note, we bring an end to our blog series on Regulatory approval for Complementary Medicines in Australia. If you wish to market your product in Australia. Let us know, we will help you to achieve a successful registration in Australia from registering a new ingredient to getting the product in the Australian market.
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