Australia Steps Closer to Setting up Expedited Review

Australia has moved its expedited review program one step closer to fruition by approving the suggestions of an expert panel, which called for the formation of an expedited review process and a choice to leverage international approvals when trying to bring a medicine to market in Australia.

Lloyd Sansom, Will Delaat and John Horvath, the panel members tasked with examining Australian drug and medical device regulations, put modifications to the path-ways for enrollment of NCEs at the center of the reports and fifty eight recommendations they released. The model suggested by the panel would give applicants 3 options: Adhere to the traditional pathway, base the filing around an unredacted evaluation report from a foreign regulator or look for an expedited approval.

Having spent the whole last year assessing the recommendations, the government has come to the conclusion it is in favor of enacting the changes suggested by the expert panel. That is not the end of the procedure. While the Australian regulatory authority Therapeutic Goods Administration (TGA) has a comprehensive picture of how it will layout some of the pathways, it is yet to flesh out the details for others. Especially, TGA still requires to set up the criteria by which it will choose whether a drug is qualified for expedited approval. TGA will seek advice from patients, healthcare experts and drug developers about the specifics.

Plans for the international regulator allowed pathway are more advanced. When active, the process will enable drug developers to file for approval on the basis of an un-redacted copy of an assessment report from a “comparable overseas regulator” and Australia specific administrative details. Presuming the drug is ideal for the Australian population and conditions — and the suggested labeling and risk management tools are suitable for the local clinical surroundings and requirements — TGA will carry out an abbreviated assessment of the application.

The pathways are some of the many expert panel suggestions adopted by the government. Of the 58 suggestions, the government has refused two. Modifications to drug and device registration decision making and expert committees were refused on the reasons that the industry, patients and healthcare experts all “strongly opposed” the suggestions. The government also refused a suggested change to the status of the Advisory Committee on Medicines Scheduling, which the panel wished to make a subcommittee of the Advisory Committee on Medicines.