TGA GMP Consultant

National Commission of Audit and the TGA

The National Commission of Audit Recommendation 19 could significantly improve the cost and time to market for new drugs. The Commission cites the example of Atorvastatin, currently the most highly prescribed and highest cost to government medicine in Australia, New Zealand only pays $2.01 in comparison to the price paid in Australia of $38.69.

The Commission recommends many changes are be made to the Pharmaceutical Benefits Scheme, pharmacy sector and the regulatory frame work to improve our health system. The most interesting aspect for me is the last clause of the recommendation:

Clause f: ”streamlining approvals for new drugs through the Therapeutic Goods Administration process by recognising approvals made by certain overseas agencies.”

This is more aligned with the drug approval process used by many other countries, for example Singapore’s HSA for example recognises six countries, if a drug is registered in three of these six countries, the registration processing time and cost is simplified.

The problem with this system, is that Australia’s TGA is one of the six, so will the proposed system rely of approval in the worlds largest economies, assuming they have the deep pockets? China, US, EU and Japan?

Extrapolating this thinking, our GMP regulations has already been outsourced to PIC/S but there could be a strong case to be made that we simply cut out the middle man follow the EU GMP regulations. We already correctly, I think adopt many of the EU guidelines and simply recognise other competent authorities GMP inspections automatically, again the question is, which other countries? The largest economies? And what will the confidence building process look like?

What is going to happen to ANZTPA during the current deregulation mood in Canberra?

The full article is available here.

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