TGA releases performance snapshot

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The TGA approved 19 new chemical entities and 42 medical devices in the final six months of 2015.

According to the regulator, the number of submissions for prescription medicines received remained relatively consistent with previous periods and mean processing times "were well below the statutory timeframes of 255 days and 45 days respectively."

For new chemical entities, the average approval time was 195 days. The average approval time for fixed-dose combinations was 150 days and 184 days for an extension of indication. It was 137 days for the 42 medical devices approved.

The average approval time for generic medicines was 164 days, only 31 days less than the average approval time for new chemical entities.

In its half-yearly performance report snapshot, the regulator said it approved 102 over-the-counter medicines and 530 change applications.

TGA approved 30 biological medicines in the final six months of 2015, compared to just 20 in the first six months of the year.

The regulator received notification for 469 clinical trials, covering prescription medicines and medical devices. Of these, 155 were phase 3, 110 phase 2 and 98 phase 1.