Australia Sees Decline In Generic Filings, Rise in Extensions And ADR Reports
Executive Summary
New drug submissions to the Australian TGA remained at the same level in 2016-17 as in the previous year, while the number of generic filings fell significantly. Extension of indications applications were up noticeably, as were adverse drug reaction reports for medicines and vaccines.
The number of new chemical entity (NCE) submissions to the Australian Therapeutic Goods Administration remained constant in 2016-17 (July to July), at 43, while the number of extension of indications filed increased noticeably from 46 to 56. The number of generic medicine submissions, on the other hand, declined substantially, from 142 to 100.
A total of 38 NCE submissions were approved in the year, while four submissions were withdrawn. Mean approval times for all three types of submission were up, with NCE times up from 193 days to 200 days, extensions from 186 days to 198 days, and generics from 170 days to 182 days. All times were well within the maximum legislative timeframe of 255 days, according to the TGA’s latest Annual Performance Statistics report.
On the drug safety front, there was a sharp rise in the number of reports of adverse reactions to medicines and vaccines, from 17,633 to 19,736 in 2016-17. As in the previous year, the largest number of reports (9,194) were sent in by companies, followed by state/territory health departments, hospitals, and members of the public.
The report notes that the rise in adverse drug reaction (ADR) reports for vaccines might reflect recent additions to the National Immunisation Program last year. ADR reports by the public also rose, probably as the result of government efforts to promote consumer reporting.
There was a significant decrease in the number of medicine recalls from 57 in 2015-16 to 32 in 2016-17, and a slight decrease from 611 in 2015-16 to 598 in 2016-17 in the number of medical device recalls.
Exports
The number of export applications for medicines (new and variations) has remained constant over the past two years at around 240, according to the report. The number of export certificates granted for medicines dropped in 2016-17 by 25%, but there was an increase in the number of device certificates issued (from 483 to 504). All medicine certificates were issued within the target timeframe (15 days), and more than 80% of device certificates and new listings/variations were also completed within the target timeframe.
Access To Unapproved Products
The TGA has a Special Access Scheme that allows the provision of unapproved therapeutic products for individual patients and consists of two pathways: Category A (notification pathway for patients with a condition that is likely to be fatal within a matter of months) and Category B (application pathway for patients who do not meet the Category A criteria).
The number of notifications and applications for the Special Access Scheme (SAS) generally increased in 2016-17, especially Category A for both medicines and devices. However, an exception was SAS Category B for biologicals, as higher-volume products previously accessed through SAS are now on the ARTG, the report notes.
Manufacturing And Clinical Trials
Demand for good manufacturing practice (GMP) clearances continued to increase, with 6,506 applications received during 2016-17 compared with 5,657 in 2015-16. Major contributing factors included “sponsors sourcing more products from new and multiple manufacturers, globalisation and company mergers, and overseas regulatory agencies undertaking more inspections in other countries, creating more evidence to be used in support of Australian GMP clearance applications.”
A total of 868 clinical trial notifications were received by the TGA in 2016-17, down from 949 in the previous year. 409 (458) of the notifications were for medicines, 152 (155) for devices, and 10 (21) for biologicals. Phase III trials accounted for the largest proportion of studies notified, at 257, compared with 189 for Phase II and 191 for Phase I.
Regulatory Compliance
The TGA’s Regulatory Investigations and Enforcement Unit conducts compliance and enforcement activities in areas like illegal import or manufacture of unapproved and counterfeit therapeutic products that can result in civil or criminal court action.
In the most recent year, the unit completed a total of 2,887 compliance actions, up from 1,760 in 2015-16, including the seizure and destruction of about 884,000 single dosage units. The bulk of the products investigated during 2016-17 related to prescription drugs (4,367), complementary medicines (599) and medical devices (166).
Most of the investigations concerned unapproved products (4,855) and counterfeits (326).
From the editors of Scrip Regulatory Affairs.