Industry Welcomes New TGA OTC Products Business Processes

27 March 2013

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27 March 2013 - TThe Australian Self Medication Industry (ASMI) has welcomed the announcement of the implementation of reforms following an extensive review of the business processes in relation to the evaluation of over-the-counter medicines (OTC) in Australia and New Zealand.

"The decision to align the administrative processes for evaluation of OTC medicines in Australia and New Zealand in readiness for the joint agency (ANZTPA) scheduled for 2016, makes good sense," said ASMI Scientific & Regulatory Affairs Director, Steve Scarff.

The implementation of the new administrative procedures will start from 15 April 2013 and will be rolled out over a period of 12 months. The staged implementation will deliver efficiency benefits as soon as possible while allowing sponsors to become familiar with the new arrangements. Sponsors will be encouraged to provide feedback on the new process to ensure continuous improvement.

"We've worked with the TGA and Medsafe for the past eighteen months to help bring about more streamlined, transparent and predictable processes which are based on a sound risk management approach."

"We are pleased about the staged approach to the implementation of the reforms. This will assist sponsors to 'get it right' without loss of application fee and with adequate feedback on any deficiencies in applications."

These reforms relate only to the administrative processes employed by the regulators. They do not alter the standards applied or the assessment of the risks and benefits associated with new and changed OTC medicines. The reforms will result in more efficient and cost-effective processes, greater transparency and predictability and improved clarity in relation to the regulatory requirements for OTC medicine applications.