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Will the Review of Medicines and Medical Devices deliver on streamlining the regulatory process?

The first in a series of progress reports

The Review of Medicines and Medical Devices Regulation (RMMDR), which was undertaken by an independent panel of eminent opinion leaders with considerable experience in the National Medicines Policy framework, was commissioned by the Commonwealth Government to identify unnecessary, duplicative and ineffective regulation which could be removed or streamlined without compromising public health.

The Stage One report of the Review has now been publicly released by the Minister of Health. Click here to view a copy of the report at the Department of Health website. A total of 32 recommendations have been made, designed to enhance regulatory efficiency without compromising the safety or quality of medicines or devices.

The Therapeutic Goods Adminstration (TGA) has since formed a review taskforce to consider, in consultation with key stakeholders, how best to implement these recommendations. The initial focus of the taskforce has been those recommendations which promise to provide the most significant benefit, and which can be relatively easily implemented. These recommendations were recently discussed in the first wave of stakeholder meetings held in early August.

Commercial Eyes was able to attend the Medicines stakeholder meeting, at which broad support was provided to the TGA to develop a mechanism to implement the new additional registration pathway options described in recommendations 3 to 9 of the report, as well as exploring more efficient ways to manage variations or changes to existing medicine registered details (recommendation 13). A good start but as we know, change requires strong commitment from all parties with an interest in cost effective regulation.

The recommended changes to the regulatory process will have a significant impact on the way we work and the timely availability of medicines. We will continue to keenly observe progress towards implementation and continue to contribute to future stakeholder engagement.

This article was written by Dr Greg Pearce, Director, Regulatory Services.

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