ANTZPA Must Reduce Cost of Regulatory Compliance

The dental industry's support for the proposed Australia New Zealand Therapeutic Products Agency (ANZTPA) is dependent upon the new body's ability to reduce the cost and time taken to overcome the regulatory hurdles in getting new products to market. This was the advice that the Australian Dental Industry Association (ADIA), the peak representative body for suppliers of quality dental product, tendered in a submission reviewing proposals outlining the proposed regulatory framework.

"ADIA's support for ANZTPA is heavily qualified by two factors. The first is that the fees, charges and administrative burden associated with the regulatory burden must not increase. The second is that the new agency must reduce undue levels of bureaucracy that create delays in introducing new and innovative dental products to the Australian market," said Troy Williams, ADIA Chief Executive Officer.

In a detailed and comprehensive review of the proposed regulatory framework, ADIA recommends that with the transition to ANZTPA the Australian and New Zealand Governments must take the opportunity to undertake long overdue reforms.

"ANTZPA should provide the necessary mechanisms to fast-track acceptance of third-party conformity assessment bodies. A lot of the work undertaken by the TGA in Australia simply duplicates the reviews that have already been completed by other organisations. It's expensive, unnecessary and ultimately leads to more expensive dental care," Mr Williams said

ADIA's submission also says the transition to ANZTPA should enhance the regulatory enforcement mechanisms in order to protect public health and safety by ensuring the systems of controls for the quality, safety, efficacy of dental products will work. ADIA believes a review of the sanctions issued would go a long way into improving public awareness and help serve as a deterrent for breaches of the legislation.

"ADIA supports a review of the enforcement mechanisms that will be available to ANZTPA, particularly the circumstances under which an infringement notice is issued for low-level breaches of the legislation. Reform is needed as the current regulatory framework is perceived to be both unenforced and unenforceable," Mr Williams said.

"With ANZTPA, the dental industry wants to ensure that community has access, within a reasonable timeframe, to new and innovative dental products. ADIA seeks a regulatory framework is based on a risk management approach designed to ensure public health and safety, while at the same time freeing the dental industry from any unnecessary regulatory burden," adds Mr Williams.