CM compliance improves

AN INCREASE in complementary medicines (CM) regulatory activity by the Therapeutic Goods Administration has seen a significant drop in the proportion of CMs with verified compliance breaches over the last six months.

The TGA has released a half yearly performance snapshot, which also confirms a jump in complementary medicines which had their registrations cancelled by a sponsor after a TGA request for information - from 20% in Jul-Dec 2016 up to 73% for the second half of 2017.

The TGA has previously been criticised for the proportion of medicines with verified compliance breaches, which ran at 80% for Jul to Dec 2016.

This figure dropped to 56% for the same period in 2017 with the increase in targeted reviews, including a strong focus on sunscreens.

The six-monthly report provides statistical information for 01 Jul to 31 Dec 2017 in relation to the TGA’s regulation of therapeutic goods for safety, effectiveness, performance and quality, tracking progress against nominated priorities.

The agency also highlighted an increase in approval rates for new prescription medicine applications and changes to existing ones within target timeframes.

Generic medicines also received a boost with shorter times to approval conclusions.

The reformed orphan drug program, which came into effect on 01 Jul 2017, created a fairer scheme aligned more closely with international criteria, the TGA said, and the Special Access Scheme (SAS) Category C notification pathway was made available on 03 Jul to improve timeliness of access to goods deemed to have an established history of use, without prior approval.

The biologicals list and conditions of use in SAS Category C - which enables supply of goods deemed to have an established history of use without prior approval - have been updated this month and are immediately effective.

See the full report at tga.gov.au.