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TGA Increases Regulations for Biological Treatments

TGA Increases Regulations for Biological Treatments

April 26,2018

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.

Regulations we already meet

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 Australian Health Practitioner Regulation Agency (AHPRA)
  • The Australian Medical Association (AMA)
  • The Australian Competition and Consumer Commission (ACCC)
  • The Code of Conduct for Biological Therapies

 

What will happen?

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.

Therefore we;

  • Expect many of the clinics around Australia to close their doors (NOT Macquarie Stem Cells).
  • Expect the cost of treatments/therapies to rise, in order to conform to new standards.
  • Expect potential delays in getting these treatments into the private/public health care.

 

What will we do?

  • We are currently in the process of building a new GMP level laboratory that will be used specifically for patient treatments.
  • We will build a separate laboratory with the strict purpose of RESEARCH.
  • We will further improve our systems and protocols beyond the current certification of ISO 9001.
  • We will upgrade our systems and processes to be included through the ARGB (Australian Regulatory Guidelines for Biologicals) and on the ARTG (Australian Register of Therapeutic Goods).
  • We will expand our collaboration into Public and Private Hospitals. (this is a long term goal)
  • We have already placed the application through HREC (Human Rights Ethics Committee) to start our blinded, placebo controlled clinical trial for Osteoarthritis. We aim to finalise this trial by the end of 2019.
    (more information here.)
  • WE WILL CONTINUE TREATING PATIENTS FOR OSTEOARTHRITIS AND JOINT INJURIES.

We pride ourselves on practising well above the required standards.

Macquarie Stem Cells will continue being Australia’s most successful Biological Treatment Centre.

 

Remember, any surgical or invasive procedure carries risks. Before proceeding, you should seek a second opinion from an appropriately qualified health practitioner.