TGA reports annual performance statistics

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The TGA's annual performance statistics report for 2016-17 reveals significant shifts in the regulator's consideration of medicines and medical devices.

The regulator considered 43 submissions for new chemical entities in the 12 months to the end of June, the same number as the year before, but 56 submissions for indication extensions - up from 46.

Average approval times rose compared to the previous year, from 193 to 220 days for new chemical entities, 186 to 198 days for indication extensions, and 170 to 182 days for generics.

The TGA approved 38 new chemical entities in 2016-17.

An increase in the number of adverse event reports, rising from 17,633 to 19,736, driven mostly by companies and state and territory health departments.

Also a significant rise in the number of applications under the Special Access Scheme. The scheme allows for the import and supply of an unapproved product for a single patient, on a case by case basis, under two specified pathways.

Category A can only be accessed by medical practitioners for patients who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur, in the absence of early treatment. The number of Category A notifications rose from 38,806 to 46,678.

Category B is an application pathway accessed by health practitioners for patients that do not fit the Category A definition. An approval letter from TGA is required before the goods may be accessed. The number of approved Category B notifications rose from 19,307 to 21,609.

The number of new clinical trials involving a medicine fell from 458 to 409.

The report reveals the regulator significantly increased the number of post-market reviews of medical devices.

In 2016-17, the TGA conduced 396 post-market reviews, up from just 80 the year before. The number of completed reviews jumped from 83 to 239.

The number of medical device incident reports also jumped sharply, from 3,841 to 4,896. The number of completed reports rose 36 per cent, from 3,608 to 4,918, with another 380 still in progress.

The number of product recalls in 2016-17 rose from 40 to 70.

It received 242 conformity assessment applications for medical devices in 2016-17, down from 257 in the previous year. The number of approved applications rose from 187 to 204.

It took an average 129 days to process applications for new medical devices, down from 133 days in 2015-16, with the average time for variations rising from 93 to 114 days.