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Half yearly performance snapshot: July to December 2017
1 July to 31 December 2017
The Therapeutic Goods Administration (TGA) prepares an annual TGA Business Plan, which identifies the priority activities being undertaken over the 2017-18 reporting period and is available on the TGA website. This Half Yearly Performance Snapshot provides statistical information for 1 July to 31 December 2017 in relation to our regulation of therapeutic goods for safety, effectiveness, performance and quality, tracking our progress against the priorities we have identified for the year.
As part of our annual plan we have been working to implement the Government's response to the Review of Medicines and Medical Devices Regulation. Following the passage of amendments to the Therapeutic Goods Regulations through the Therapeutic Goods Amendment (2016 Measures No. 1) Bill, this reporting period now includes new data sets in relation to:
- Orphan Drugs
- Special Access Scheme
- Authorised Prescriber Scheme and
- Priority pathways for medicines and medical devices.
Further information about how therapeutic goods are regulated in Australia can be found on the TGA website.
The TGA has maintained a high level of activity while also progressing regulatory reforms over the reporting period, 1 July to 31 December 2017. Highlights are as follows:
Orphan drug program reform
- A reformed orphan drug program came into effect on 1 July 2017 and created a fairer program that aligns more closely with international criteria without impeding the availability of drugs for rare diseases. The objective of the orphan drug program is to provide an incentive to sponsors to bring medicines for a small population to market and make medicines available to patients who would not otherwise be able to access them. The incentive is in the form of a waiver of application and evaluation fees.
Special Access Scheme
- The Special Access Scheme (SAS) Category C notification pathway was made available on 3 July 2017 to increase timeliness and ease access to therapeutic goods for Australian patients. This pathway allows certain unapproved goods when used for a particular indication to be supplied immediately to patients by an authorised health practitioner without first requiring approval by the TGA. A total of 4,975 notifications for access to therapeutic goods were received under the new SAS Category C notification pathway.
Authorised Prescriber Scheme
- From 3 July 2017, changes were made to the Authorised Prescriber Scheme to streamline the application process by removing the requirement for doctors to submit clinical justification with their application.
Priority review of prescription medicines
- A new priority review pathway was implemented on 1 July 2017. Priority review involves faster assessment of vital and life-saving prescription medicines for which a complete data dossier is available. The target timeframe of 150 working days is up to three months shorter than the standard prescription medicines registration process. The Priority review pathway operates with new and flexible business processes in order to facilitate faster assessment for registration, while maintaining TGA's high standard for efficacy, safety and quality.
Priority review of medical devices
- Priority review of certain novel medical devices commenced from January 2018. Priority review designation is for breakthrough technologies treating life threatening or seriously debilitating conditions where there is unmet clinical need. Applications which are granted a Priority review designation will be allocated 'front-of-queue' priority throughout the relevant assessment process (whether that is for conformity assessment and/or inclusion on the Australian Register of Therapeutic Goods (ARTG)).
- Over the reporting period, 166 Category 1 (including 22 New Chemical Entities (NCE) and 55 new generic medicines) and 695 Category 3 applications were approved. This represents an increase against the equivalent period in 2016 (156 Category 1 and 665 Category 3 applications). Mean and median approval times were below the statutory timeframes.
- Mean and median approval times for new generic medicines (190 and 185 working days respectively) and Product Information changes (130 and 129 working days respectively) were below that of NCE (209 and 212 working days respectively) as these application types are typically processed without referral to independent expert advisory committees.
- The number of new medicine applications (N1 to N5) and applications to change existing medicines (C2 to C4) approved in July to December 2017 (300) was higher than for the equivalent period in 2016 (206). Despite the increase in numbers for these application types, the percentages of applications completed within target timeframes were well above the 80% target (93% for N4 applications and 100% for all other application types).
- In line with the increase in the proportion of medicines which were cancelled by a sponsor after our request for information (73%, compared with 20% for July to December 2016), and the increase in the number of targeted reviews in recent years, the proportion of medicines with verified compliance breaches decreased to 56% (compared with 80% for July to December 2016).
- There was a 69% increase in the number of completed new medical device conformity assessments (44, compared with 26 for July to December 2016) and a 39% increase in changes or recertification (88, compared with 63 for July to December 2016).
- There was also a significant increase in applications for Class 1 medical devices and in vitro devices (IVDs) on the ARTG (1,545, compared with 1,209 for July to December 2016).
Licensing and manufacturing
- There was a significant increase in inspections conducted in this period of Australian manufacturers (96, compared with 74 in the equivalent period in 2016) and overseas manufacturers (49, compared with 30 in the equivalent period in 2016). This was due to a combination of factors including increased inspection resources, and performing more inspections with shorter inspection duration.
- Initial inspections conducted for Australian manufacturers within 3 months of application increased from 75% to 92% when compared with the equivalent period in 2016. This improvement was achieved by ensuring initial inspections were conducted in a timely manner.
Access to unapproved therapeutic goods
- Consultations on the updated Australian Clinical Trials Handbook were completed. This document is being updated to reflect current practice and improve consistency in guidance documents between the TGA and the National Health and Medical Research Council. Online portal functionality was improved for Sponsors and a total of 481 new Clinical Trial Notifications were received.
Medicine and vaccine adverse event reports
- We have been working closely with state and territory health departments to monitor the safety of vaccines included in the National Immunisation Program. This work is reflected in the increase in the number of Adverse Drug Reaction Reports related to vaccines submitted by state and territory health departments.
- A new case prioritisation model and improved process was implemented for the assessment of referrals for compliance or investigative action. This, along with improved information on target imports, has strengthened our relationship with the Australian Border Force. Consequently, there has been a substantial increase in compliance actions during the period (1,530, compared with 789 in July to December 2016), including 363,763 units of imported therapeutic goods destroyed as being non-compliant with the regulatory framework.
- Analysis of outcomes for blood-related recalls for the previous ten reporting periods shows activity is now lower than previous levels. Outcomes for medicine and medical device-related recalls have remained relatively consistent when compared with previous reporting periods.
- Tables 2, 3 and 5