Looking for a TGA certified manufacturer? We are proud to be a global supplier of high-quality supplements, and we value our Australian brand clients. This is why we offer TGA certified facilities to our clients who need this certification. If your brand sells supplements in Australia, we want to help you learn more about the organization and the importance of TGA-compliant supplements.
Feel free to contact or call us today to speak directly to one of our account executives about your TGA needs.
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What Is the TGA?
The Therapeutic Goods Administration is an Australian regulatory body that is responsible for analyzing and approving medicines, vitamins and other medicinal products made by any TGA manufacturer. According to the TGA’s website, its work is vital in benefitting and protecting the daily lives of Australians. It also regulates blood products, medical devices and medical treatments. TGA approval is critical to all medical and dietary supplement product manufacturers.
What Does the TGA Do?
These are the main purposes of the TGA license and its regulatory activities:
- Conduct assessments for new products.
- Monitor the manufacturing and distributing activities relating to existing products.
- Ensure that Australians have access to therapeutic advances as quickly as possible.
Anything that is medicinal or therapeutic interests the TGA. In 1989, Australia passed the Therapeutic Goods Act, which mandated that all types of medicines and supplements must be regulated. It classified most health supplements as complementary medicines, which means that anyone selling supplements in Australia must ensure that all TGA standards are met in the manufacturing process.
Types of Supplements That Are Regulated Under TGA Manufacturing
If a supplement that you want to make or buy has a therapeutic purpose, the TGA regulates it. These are some examples of supplements that the TGA is responsible for regulating:
- Herbal supplements
- Diet supplements
- Vitamin supplements
- Mineral supplements
- Nutritional supplements
- Homeopathic supplements
- Several aromatherapy supplements
- Traditional Chinese Medicine supplements
- Indigenous Australian supplements
- Ayurvedic medicinal supplements
- Any other traditional supplement
How the TGA Regulates
The TGA requires all substances to be made from high-quality ingredients using high manufacturing standards. These are the steps that it follows:
- Pre-market assessment of products.
- Post-market monitoring of products.
- Enforcement of standards for products.
- Licensing of manufacturers in the country and ensuring compliance of any overseas manufacturers that export to Australia.
The TGA divides therapeutic goods into two categories, which are medical devices and medicines. Unless a product is exempted, it must be listed as included. For medicines, they must be marked to indicate if they are listed or registered.
How the TGA Handles Problems
In some cases, problems are not initially evident with devices or medicines. This is why the TGA continues to monitor everything that is applicable. If there are problems, it may take these actions:
- Additional testing of the product.
- More intensive monitoring of the product.
- Removal of the product from the market.
TGA Risk Management Considerations
When the TGA assesses products, it considers the risks in relation to the benefits. Since every therapeutic product carries some form of small or size-able risk, the agency’s job is to determine if the potential benefits outweigh the level of potential harm. If there are risks, manufacturers must clearly communicate them. However, some risks do not disqualify a product from being on the market. These are just a few examples of risks that the TGA evaluates:
- Improper dosing effects and toxicity risks.
- Long-term use or exposure effects.
- Temporary or permanent harm from side effects.
- The amount and severity of potential side effects.
Limitations of the TGA
Since the Therapeutic Goods Act of 1989 uses a blanket term of complementary medicines for most supplements, some people have questions about certain products. For clarification, these are some examples of things that the TGA does not regulate without the presence of a health-related claim:
- Veterinary treatments
- Foods
- Cosmetics
A health claim is a statement that indicates a health benefit of using a substance. If you are not sure about how a product that you want to manufacture should be classified, we can help you determine the right answer.
Why Is TGA Certification Important?
The TGA is important for maintaining safety and quality in the medical devices and medicines that are marketed in Australia. Its continued monitoring of substances is vital for identifying problems, issuing any important recalls and ensuring that manufacturers do not become lax in their procedures.
Although regulatory compliance is often a source of stress for merchants all over the world, proper certification is essential for the future of your business. To Australian brand owners, TGA certification is imperative. These are some of the benefits of TGA-compliant supplements:
- Strengthen your brand and how people perceive it.
- Help build your position as a leader in your market or community.
- Create a base of loyal customers and boost your sales.
When your customers know that you take compliance seriously, they know that you take their safety seriously. This is especially critical if you plan to sell supplements that are designed for children or teens.
How We Can Help With TGA Compliance?
We understand that you have plenty of responsibilities in running your business and marketing your products. When choosing superior for your TGA manufacturer, you have more time to focus on your other tasks. We understand the complexities of TGA regulations and requirements.
Why Choose Us??
Superior has handled many types of supplement manufacturing projects for clients in Australia and other international countries. With a product portfolio that includes 95% of delivery forms, and packaging configuration, we can handle any project efficiently. Also, we are exceptionally good at getting your shipment exported to you in a timely manner. These are some other reasons why our clients rate our services highly:
- You have your own dedicated account representative.
- We give you access to a large support team.
- We can handle complex manufacturing, R&D and testing projects.
- Our manufacturing facilities and procedures meet all compliance rules.
- With our extensive capacity, we can handle your growing needs in the future.
- As a responsible manufacturer, we carefully select our raw materials providers and have a robust supply chain.
Those are just a few reasons why we have many satisfied customers, including several Fortune 500 companies. We are certified by the TGA to manufacture, test, package and distribute supplements to Australian customers. Please contact us to discuss your needs.
