29 May What the heck is TGA approved and do I need it for my product?
What does TGA-approved actually mean?
The Therapeutic Goods Administration (TGA) is an Australian Government body that regulates medical devices, drugs, and any item that claims therapeautic benefits from its use (supplements, herbal medicine etc). Their main role is to control quality, safety and efficacy of therapeutic goods that are used and sold in Australia, regardless of where it is imported from, or made in the world. When something is TGA approved, it means it has gone through a VERY thorough application process to be approved to be safe for the public to use and buy.
Here’s a good example:
When I prescribe an Acne Chinese medicine (herbal) formula to my patients when they attend an appointment at the clinic, the Chinese herbal medicine does not need to be approved by the TGA because it is being prescribed/formulated and administered by a registered practitioner (the risk to a patient is low, and the liability is on the treating practitioner). However, if this same formula was to be bottled up and a consumer was able to buy it off the shelf at a store, or order it online, without seeing a registered practitioner, the product needs to be TGA approved to be safe enough for someone to take without professional assessment.
What are some items we may be surprised to find on the TGA list?
Because anything that claims therapeutic benefit (eg: “helps nourish skin” or “can help maintain healthy digestive system”) must be TGA approved, so many everyday products we use are found on the TGA list. Some of these products include sunscreens, vitamins, moisturisers… even vitamin E oil! An interesting one is medical devices and vaccines, too.
Break it down for us, what are the steps you need to take to get your product approved and on the market?
The TGA process is a very lengthy and tedious application process. Every little detail needs to be provided to them to approve the product. Even the registration request to become a sponsor to start a TGA application is a process!
So in summary, I had to:
1. Register to be a sponsor. A sponsor is the person/company involved with making the application for the product approval.
2. When that is granted, you are given a password and username to log into a TGA portal. I then deciphered my way into how to create a new application, and got started.
3. You plug in as much information as possible. You provide details such as: ingredients (and details down to which part of a plant you’re using), weight (in their units, and indicated active ingredients in ratio and percentage per tablet/gram/capsule/whatever form your herbs are in), indications (wording of this is very strict. cannot claim to treat, or cure, just “assist”), contraindications, warnings. You have to tell them what the components of these herbs are: for eg: ginger has components zingiberene and bisabolene, so ginger is not just ginger. You need to state every specific step in the processing of the herbs, eg what solvent is used in the extraction steps, how is it granulated and what is the binder etc. All this is in percentage and ratios.
You only get one shot at most of the information enter, because once its entered and approved, changing any detail (even the name, or the indications etc) will incur a change fee. Three or more changes, then it becomes a new application altogether.
4. You must separately (still through TGA portal) apply to have the manufacturing facility GMP clearance approved by sending them certifications and information about the type of facility, what they are approved to make in that factory, etc, etc, etc. There is no detail too small! Once you get the factory GMP approved, you get a clearance ID which is then plugged in to answer one of the questions in your TGA portal as part of your application.
5. When you go to send the application in, there is a button that is “verify” … The portal will verify and assess the information that is in the portal, and come up with a whole list of things that need to be added, or elaborated on, so you go back to research that info, and plug it in. This process happens over and over until the TGA is satisfied with the information, in which case the application will actually get accepted.
6. When accepted, the TGA can take weeks or months to return to you with an answer for certification.
How long are we talking here?!
My process for Zilch started in January, and I was granted approval in October that year. I think I was lucky as I was fast tracked with the GMP clearance ID. There was a few months wait to get the clearance ID but I sent several emails stating urgency due to manufacturing contracts etc.