Lloyd Sansom, Will Delaat and John Horvath, the panelists tasked with analyzing Australian drug and medical device regulations, put changes to the pathways for registration of new chemical entities at the center of the reports and 58 recommendations they released. The model proposed by the panel would give applicants three options: Follow the traditional pathway, base the filing around an unredacted evaluation report from a foreign regulator or seek an expedited approval.
Having spent the past year evaluating the recommendations, the government has concluded it is in favor of enacting the reforms proposed by the expert panel. That is not the end of the process. While the Therapeutic Goods Administration (TGA) of Australia has a detailed picture of how it will design some of the pathways, it is yet to flesh out the details for others. Notably, the regulator still needs to establish the criteria by which it will decide whether a drug is eligible for expedited approval. TGA will consult with patients, healthcare professionals and drug developers about the specifics.
Plans for the overseas regulator-enabled pathway are more advanced. When active, the pathway will allow drug developers to file for approval on the basis of an unredacted copy of an evaluation report from a “comparable overseas regulator” and Australia-specific administrative information. Assuming the drug is suitable for the Australian population and conditions — and the proposed labeling and risk management tools are appropriate for the local clinical environment and requirements — TGA will perform an abbreviated evaluation of the application.
The pathways are some of the many expert panel recommendations adopted by the government. Of the 58 recommendations, the government has rejected two. Changes to drug and device registration decisionmaking and expert committees were rejected on the grounds that the industry, patients and healthcare professionals all “strongly opposed” the recommendation. The government also rejected a proposed change to the status of the Advisory Committee on Medicines Scheduling, which the expert panel wanted to make a subcommittee of the Advisory Committee on Medicines.
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