Macquarie Stem Cells has provided this information to educate the public. We don’t aim to encourage consumers to seek out such treatments prior to an assessment by a health professional to determine your suitability for treatment.
The TGA has made the decision to increase the regulation of biological treatments effective as of 1st of July 2018.
In a nutshell, the TGA wants biological treatments to be safer for the public. Our laboratory systems and processes are accredited to the international standard ISO 9001. The TGA wants everyone to move to the GMP manufacturing standard with clean rooms. They also want the cell separation process to be included in the ARTG register.
This is achievable, however it will be a long and expensive task.
Often people hear “biological treatment industry is not regulated”, that is completely incorrect. We are medical and scientific professionals, the regulations we have to abide by are greater than many other health professionals.
Below is a list of the regulations we already meet.
The new regulatory increases TGA has added will commence shortly, there will be a transitional period for companies that wish to continue providing biological treatments to the public.
We will be one of the very few companies that will continue and push on with the transitional changes.
We pride ourselves on practising well above the required standards.
Remember, any surgical or invasive procedure carries risks. Before proceeding, you should seek a second opinion from an appropriately qualified health practitioner.