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Half yearly performance snapshot: July to December 2016
1 July to 31 December 2016
The Therapeutic Goods Administration reports on its performance against the Regulator Performance Framework (the Framework). The Framework came into effect on 1 July 2015 and our first report, covering the period 1 July 2015 to 30 June 2016, was published on the TGA website in November 2016 (TGA key performance indicators and measures: Regulator Performance Framework).
To provide stakeholders with a progress update and assist with charting our performance, the TGA also releases a Half Yearly Performance Snapshot (the Snapshot). This Snapshot covers the period of 1 July to 31 December 2016.
The six months from 1 July to 31 December 2016 was a period of significant activity for the TGA. Highlights are as follows:
- A significant workload continued, with 156 Category 1 (including 23 New Chemical Entities (NCE) and 53 new generic medicines) and 665 Category 3 applications approved. While this represents a slight decrease against the equivalent period in 2015, where 193 Category 1 and 685 Category 3 applications were approved, many applications, particularly related to cancer medicines, are increasingly more complex in nature.
- The mean and median approval times for Category 1 NCE (200 and 205 working days respectively) and Category 3 minor variation applications (between 22 and 24 working days) were well below the statutory timeframes of 255 days and 45 days respectively.
- The mean and median approval times for new generic medicines (177 and 161 working days respectively) and Product Information changes (142 and 138 working days) were below that of NCE as these application types are typically processed without referral to independent expert advisory committees.
- The number of new medicine applications (N1 to N5) approved during this period (77) increased slightly compared to January to June 2016 (59) but was within the variability of previous periods.
- The percentages of applications completed within target timeframes were well above the 80% target (95% for C1 applications and 100% for all other application types). Business process reform and a streamlined submission process have led to efficiencies in completing applications within target timeframes.
- The number of new ingredients permitted for use in listed medicines increased substantially compared to the corresponding period in 2015 (from 14 to 50), largely due to new ingredients being made available for excipient use in specific circumstances in listed medicines. Two updates were made to the Permissible Ingredients Determination under section 26BB of the Therapeutic Goods Act 1989 (the Act) to enable the use of these ingredients in listed medicines.
- We increased the number of initiated targeted reviews from 89 to 235 based on the data gathered from random compliance reviews conducted in 2015-16. We identified trends in non-compliance and initiated projects targeting groups of listed medicines based on non-compliance issues. These were published on our website at a dedicated compliance page.
- Increased targeted reviews resulted in the proportion of medicines with verified compliance breaches being 80% (167) for this period, compared with 72% (136) in the corresponding period in 2015.
- A total of 258 Level 2 compulsory audits which include the assessment of clinical evidence were completed in this period compared to 107 in the corresponding period in 2015. Whilst during 2016 there were delays in commencing the clinical assessment component for high risk (Class III and Active Implantable Medical Devices) application audits resulting in process times of around eight to nine months, we have introduced a range of strategies to address this issue and reduce the wait time for assessments.
Licensing and manufacturing
- We have revised our business practices to apply a risk-based approach to the scheduling of inspections for the manufacture of medicines and biologicals, resulting in significant improvements in processing times. Specifically, this period has seen a 16% increase of initial inspections conducted of Australian manufacturers and a 25% increase of initial certifications of overseas manufacturers compared with the equivalent 2015 reporting period. These improvements have been achieved by focusing on initial inspections as opposed to re-inspections and taking into account any history of consistent compliance with Good Manufacturing Practice (GMP) guidelines over time.
- As at 31 December 2016, there were 252 companies holding Australian manufacturing licences covering 396 sites; and 397 overseas companies holding manufacturer certificates covering 399 manufacturing sites.
Access to unapproved therapeutic goods
- There was a slight reduction in the number of Clinical Trial Notifications (CTN) received (417) compared to the corresponding period in 2015 (469).
- Ongoing modifications to the online CTNs form have been made to improve its functionality for clinical trial sponsors.
Special Access Scheme
- The number of completed applications and notifications under the Special Access Scheme for Category A medical devices increased (from 1,960 to 2,832) compared to the corresponding period in 2015.
Authorised Prescriber Scheme
- There was an increase in the number of authorised prescriber approvals for medicines (from 297 to 391) and medical devices (from 121 to 177) compared to the corresponding period in 2015.
Medicine and vaccine adverse event reports
- We have worked closely with stakeholders to highlight the importance of reporting adverse events to the TGA. The National Prescribing Service (NPS) hosts an online learning module for health professionals and in April 2016 we undertook online advertising using Google and health professional publications. This resulted in increased awareness and completion rates of the NPS modules, especially in the nursing profession. There was an increase of 1,371 in notifications of medicine and vaccine adverse events compared to the equivalent 2015 reporting period.
- Between 1 July and 31 December 2016, 1,229 samples were tested and a total of 6.9 million doses of 53 different vaccine products were released.
- The number of products subject to investigation for compliance issues increased by 111% from the equivalent 2015 reporting period. We attribute increased reporting of non-compliance to online educational material informing the Australian public about the dangers of importing medicines and medical devices not approved for supply in Australia and without medical supervision. We have also enhanced our relationships with government stakeholders with responsibility for law enforcement, consumer protection and the health of Australians.
- We facilitated the destruction of a total of 336,119 'units' of imported therapeutic goods. These therapeutic goods were imported outside of the TGA regulatory scheme and treated as prohibited imports under the Customs Act 1901 resulting in seizure and destruction by the Australian Border Force (ABF). Reporting on the destruction of these units commenced this reporting period and will be incorporated into subsequent reports.
- Ten products were established to be counterfeit therapeutic goods presenting a risk to public health. Safety alerts were published on the TGA website and the ABF was notified.
- Initial review of 90% of the safety related recall (i.e. Class I and II) actions for medical devices, medicines and biologicals managed during the reporting period was undertaken within the target timeframe of two working days from the date of notification.
|||One unit equals: one tablet / one pill / one ampoule in case of injectable pharmaceutical / one litre if medicine in liquid / 1 kg in case of raw material.|