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A Closer Look at the TGA Approval Process for Pharmaceuticals

When your company specializes in the development of pharmaceuticals, there are naturally a lot of things you need to consider when it comes to getting a new product out of the lab and into the hands of the consumers it’s meant for. If you’re planning on marketing your new miracle product in Australia, one of the most important considerations is getting the green light from the Therapeutic Goods Administration (TGA).

Of course, knowing your new drug needs the approval of the TGA is one thing. Successfully navigating the process of applying and meeting all of their criteria is another. Let’s take a closer look at the TGA and examine how pharmaceutical developers from all countries can get the thumbs up they need.

What is the TGA and what is it responsible for?

The Australian Drug Evaluation Committee (ADEC) can definitely make recommendations as far as which pharmacy drugs eventually enter the market and which don’t. The ADEC also reviews cases that require the eye of an expert. However, before any given pharmaceuticals or can be marketed to Australian citizens, it needs to be evaluated by the TGA, as they will have the final say on whether or not the product is approved.

The responsibilities of the TGA to the Australian people cover a number of different areas. In addition to the ultimate evaluation of supplements, prescription pharmaceuticals, and over-the-counter pharmacy drugs, the TGA reviews treatments categorized as “alternative medicines”. They also evaluate medical devices before they hit the market.

Once a given item is approved, it will earn an official listing in the Australian Register of Therapeutic Goods (ARTG). It is important to note, however, that being listed or registered by the ARTG is not necessarily indicative of endorsement by the TGA.

What is the process a drug goes through during approval?

When it comes to prescription medications, the TGA requires that evidence regarding their safety risks and health benefits can only come from TGA-approved clinical trials. After evaluating the data, the TGA needs to feel that any proven or widely acknowledged side effects are acceptable. Key information about the benefits will also be checked for accuracy and reasonable clarity.

This process can be quite lengthy, often taking many months or even years, so those seeking approval for a supplement or pharmaceutical shouldn’t expect to receive a decision overnight. Approval for sale requires the compilation of enough data to be considered conclusive and that means a multi-stage testing process. The stages in regard to most drugs are the following:

• Initial laboratory experiments involving animal and biochemical tests
• Phase I clinical trials – 20-80 volunteers in perfect health
• Phase II clinical trials – 100-150 volunteers with targeted illness
• Phase III clinical trials – 1000-3000 volunteers with targeted illness

If the results of the third phase are promising and all safety and manufacturing standards are met, the drug will be approved. However, the TGA’s involvement in the drug’s relationship with the public won’t stop there. It will continue to be monitored going forward and standards will be fully enforced.

What can other countries expect when submitting drugs for approval consideration?

Pharmaceutical companies looking to eventually market their drugs in Australia should keep the standards of the TGA in mind right from day one in order to ensure a smooth process. This means that when clinical studies are arranged, the conditions and specifics should be checked in order to verify compliance with the TGA’s standards. Only TGA-approved clinical data will be accepted as evidence that a drug would be safe and beneficial for the Australian public.

Once the drug is approved for sale, it’s equally important to make sure that manufacturing facilities remain in compliance as far as the TGA’s expectations. Such compliance will be initially verified by the TGA. Continued compliance will be monitored going forward into the future as well.

If at any time a foreign drug that had previously been approved by the TGA is shown to no longer be in compliance with strict TGA standards, then the degree of monitoring may be increased. If the infractions are severe or if any other issue is discovered with the medication in question, the drug may even be removed from the market altogether.

At the end of the day, getting a drug, therapy, treatment, or piece of medical equipment approved by the TGA is far from impossible. However, success does mean making sure one’s bases are all covered. This means determining and complying with applicable TGA standards to the letter before, during, and after the approval process begins.

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