Regulatory Approval For Nutraceuticals (Complementary Medicines) In Australia Part-III
Do you know? Global regulators consider Australian Nutraceuticals complementary medicines () the consumer protection benchmark. In Australia and internationally, numerous complementary medicines are considered premium brands. That is obvious because the complementary medicines’ approval follows a strict regulatory regime and is one of the stringent 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 ten 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 Nutraceuticals (Complementary Medicines) In Australia Part-I and Regulatory Approval For Nutraceuticals (Complementary Medicines) In Australia Part-II, to understand the regulations for complementary medicines in Australia.
Do you need to register your complementary medicines (nutraceuticals) or need any other regulatory support in Australia? So contact us at firstname.lastname@example.org or put your required details in the below form.
5. Label and Advertisement of the nutraceutical product
- The product must have a label in compliance with Australian labeling regulations.
- All product labels must contain a product AUST number on them.
- The sponsor shall market and advertise therapeutic goods to consumers in a socially responsible manner to promote the quality use of therapeutic goods and does not mislead or deceive the consumer.
- Advertising 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 (for example, newspapers, magazines, television, and radio) must be pre-approved before their publication or broadcast.
6. Australian based Sponsor
- Only an “Australian Sponsor” can market therapeutic products in Australia
- 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.
TGA submission for nutraceuticals (complementary medicines) in Australia
- After understanding these six key elements (the first four of them covered in our previous blog of this series), the sponsor can compile the dossier and submit it to the TGA.
It is advisable for sponsor to arrange a pre-submission meeting with TGA for submitting high quality complete dossier.
- A sponsor needs to present a dossier with all data in the best possible format. TGA website provides the dossier format and modules in which they would like to receive the application. Check out this dossier format registration of Complementary Medicines with TGA Australia here.
- The sponsor needs to justify if the application does not meet a specific technical requirement or does not adhere to an applicable guideline.
- The sponsor can include the listed complementary medicines in the ARTG via an electronic application process. It allows easy and quick access to the market for low-risk complementary medicines.
- TGA may 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 requires more information, they communicate to the applicant and provide a justifiable time to provide the necessary data.
For the period applicant is making provision of the data, TGA follows the stop clock mechanism.
TGA is 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 complementary medicines in Australia
To monitor 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
Our previous blogs cover the first two points. (see part I & part II). let us have a quick recap of them here.
1. Licensing and Audit of Manufacturers units
- The Act requires each Australian manufacturer of human-use medicinal products to hold a manufacturing license.
- TGA ensures compliance with Australian GMP by carrying out pre-licensing audits and regular on-site audits along with other GMP aspects, 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.
- TGA evaluates the higher-risk medicines for quality, safety, and efficacy by TGA.
- After approval, TGA lists the medicines in the ARTG as registered medicines.
- The TGA evaluates the efficacy by examining data from controlled clinical trials for registered and assessed listed products.
- The applicant can also use a sufficient description in standard textbooks/guidelines to support efficacy,
- Listed products are considered low-risk 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;
- 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.
The TGA has established an adverse reaction reporting system for medicines in Australia. The sponsors of all medicines included in the ARTG are under an obligation to report adverse reactions to the TGA.
TGA reviews all the adverse reaction reports received for complementary medicines for 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 fostering a regulatory environment that is supportive of innovation, research, and high-skilled manufacturing. TGA made regulatory reforms to minimize the regulatory and administrative burden for businesses. Also, ensure timely access to quality therapeutic goods to consumers.
- As a part of this commitment, the TGA 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 are ending the blog “Regulatory approval for Nutraceuticals (Complementary Medicines) in Australia” If you wish to market your product in Australia, let us know. We will help you achieve registration in Australia by registering a new ingredient to get the product in the Australian market.
Do you need to register your complementary medicines (nutraceuticals) or need any other regulatory support in Australia?
Contact us at email@example.com or put your required details in the below form.