Australia-New Zealand Therapeutic Products Agency welcomed

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It's been a long time coming, but ANZTPA is nearly here.

The proposed establishment of the Australia-New Zealand Therapeutic Products Agency (ANZTPA) has been welcomed by the Australian Dental Industry Association (ADIA), the representative body for the manufacturers, importers and suppliers of products used in dentistry.

“ADIA was a supporter of ANZTPA when it was first proposed several years ago, and we have always believed that its establishment is in the best interests of both patients and the Australian dental industry,” said Troy Williams, ADIA executive officer.

The proposals to establish ANZTPA follows an agreement signed on 20 June 2011 between the Australian and New Zealand Prime Ministers. The agreement signals the intent of both governments to progressively implement the joint agency over a period of up to five years. A staged approach focused on medicines, medical devices and biologicals will be adopted in order to establish the requisite building blocks for one regulatory system.

“Both governments have agreed to a three staged approach that first looks at business to business and resource sharing arrangements, then the establishment of a common regulatory framework. The creation of ANZTPA is the third and final stage. ADIA supports this approach given the many difficulties that need to be overcome,” Mr Williams said.

Meanwhile, the establishment of a Senate inquiry into the role of the Therapeutic Goods Administration (TGA) in regulating medical devices has been welcomed by the Australian Dental Industry Association (ADIA).

According to ADIA, the establishment of the senate inquiry is timely given the many challenges that the TGA faces enforcing the medical device regulatory framework.

“On balance, ADIA supports the current regulatory framework administered by the TGA.  That said, the Australian dental industry has observed areas for improvement, particularly in the area of regulatory enforcement,” said Mr Williams.

According to ADIA, the major challenge is associated with the importation of substandard dental product supplied outside the framework established by the Therapeutic Goods Act (Cth) 1989.  In December 2010, the TGA decided to address this problem by adding further regulation, however ADIA does not believe this is the best approach

Initial proposals were for a Senate inquiry to review concerns associated with the regulation of hip implants.  ADIA believed that a broader review was necessary and the Association communicated this need to a number of Senators.

“We are pleased that the Senate has responded to ADIA’s representations with a wide-ranging inquiry into the role of the TGA’s regulation of medical devices,” Mr Williams said.

 

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1 COMMENT

  1. So does this mean that Australia’s laws for TGA approval will be more relaxed or more stringent than ever before?

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