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Annual performance statistics report: July 2017 to June 2018
About the Therapeutic Goods Administration
The Department of Health, through the Therapeutic Goods Administration (TGA) is responsible for assessing whether therapeutic goods available for supply in Australia are safe and fit for their intended purpose.
Products for which therapeutic claims are made are assessed by the TGA and entered on the Australian Register of Therapeutic Goods (ARTG). At 30 June 2018 there were 89,553 therapeutic goods on the ARTG. 11,032 new products were added to the ARTG during the reporting period. All therapeutic goods registered on the ARTG can be lawfully manufactured and supplied in Australia and include prescription medicines, over-the-counter medicines, complementary medicines, biologicals, and medical devices.
The TGA regulates the supply of:
- medicines prescribed by a doctor or dentist
- medicines available from behind the pharmacy counter
- medicines available in the general pharmacy
- medicines available from retail outlets
- complementary medicines, such as vitamins, herbal and traditional medicines
- medical devices, from simple devices like bandages to complex technologies like heart pacemakers
- products used to test for various diseases or conditions (in vitro diagnostic devices (IVDs), such as blood tests
- vaccines, blood products, and other biologics.
We play a regulatory role in overseeing the manufacturing process and advertising of therapeutic goods. We support compliance with the regulatory framework, working with state, territory and federal counterparts to remove unsafe/non-compliant therapeutic goods from the Australian market.
More information about how therapeutic goods are regulated in Australia can be found on our website.
Each year we provide information about our regulatory performance through the TGA Annual Performance Statistics Report and the Half Yearly Performance Snapshot. We also report annually on our performance against the Regulator Performance Framework through the TGA Self-Assessment (Key Performance Indicators) Report.
The statistics contained within this report cover the period 1 July 2017 to 30 June 2018, and contribute to annual publications that track our progress against the priorities we have established for the financial year.
Performance highlights: July 2017 to June 2018
Key observations for 2017-18 are summarised below, including trends and notable changes from previous reporting periods.
As part of our 2017-18 activity, we have continued to implement the Australian Government's Response to the Review of Medicines and Medical Devices Regulation (MMDR). Following the passage of amendments to the Therapeutic Goods Regulations 1990 that follow on from commencement of the Therapeutic Goods Amendment (2016 Measures No.1) Act 2017 and the Therapeutic Goods Amendment (2017 Measures No.1) Act 2018, this reporting period now includes new data sets in relation to:
- Orphan Drugs
- Special Access Scheme
- Authorised Prescriber Scheme
- Priority pathways for medicines and medical devices
- Pharmacovigilance Inspection Program
- Provisional approval pathway for prescription medicines
- An automated notification process for very low risk changes to biologicals and registered medicines
- A pathway for use of un-redacted assessment reports from Comparable Overseas Regulators.
In this section: Orphan drug program reform | Special Access Scheme | Authorised Prescriber Scheme | Priority review of prescription medicines | Pharmacovigilance Inspection Program | Provisional approval of prescription medicines | Automated notifications for very low risk changes to registered medicines | Comparable Overseas Regulator report-based process | Prescription medicines | Over-the-counter medicines | Listed medicines | Biologicals | Medicine and vaccine adverse event reports | Medical device conformity assessment | Medical device incident reports | Exports | Access to unapproved therapeutic goods | Medicines and biologicals manufacturing | Recalls | Laboratory testing | Regulatory compliance
Orphan drug program reform
Our 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 reforms have also expanded the program to include new dosage form medicines.
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
A new Special Access Scheme (SAS) pathway – Category C – was established in July 2017. Category C is a notification pathway allowing certain unapproved therapeutic goods that are deemed to have an established history of use to be supplied to an individual patient or class of patients without TGA approval. Under this pathway, health practitioners may be authorised to supply certain unapproved therapeutic goods for a particular indication as specified in legislative instruments. The introduction of Category C has enabled more streamlined access under the SAS.
Authorised Prescriber Scheme
A change to the application process of the Authorised Prescriber Scheme was implemented on 1 July 2017 to streamline access to unapproved therapeutic goods. This change removed the requirement for a medical practitioner to resubmit their clinical justification to the TGA, as this is required to be submitted to, and evaluated by, a Human Research Ethics Committee or specialist college. The duration of approval can now also be extended for therapeutic goods which are deemed to have an established history of use.
Priority review of prescription medicines
A new priority review pathway was also 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 our high standard for efficacy, safety and quality.
Pharmacovigilance Inspection Program
The inspection program involves TGA representatives interviewing sponsors and reviewing documents in order to assess sponsors' compliance with pharmacovigilance requirements. The program is largely based on the UK Medicines and Healthcare products Regulation Agency's successful pharmacovigilance inspection program, but also takes into consideration unique Australian factors. The launch of the program in September 2017 was preceded by substantial stakeholder engagement and consultation, particularly with medicine sponsors. The rollout was supported by a series of information sessions held around the country.
Provisional approval of prescription medicines
In March 2018, a new provisional approval pathway for prescription medicines was implemented. This pathway allows sponsors to apply for time-limited provisional registration on the ARTG on the basis of preliminary clinical data, providing access to certain promising new medicines where we assess that the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.
Provisional registration is limited to a maximum of six years and will automatically lapse at the end of a specified period unless sponsors are able to demonstrate that they have met the conditions imposed on the provisional registration. Sponsors may apply for full registration when sufficient clinical data to confirm the safety and efficacy of the medicine are available.
Automated notifications for very low risk changes to registered medicines
A 'notifications' process was introduced in 2017 for very low risk changes to biologicals and to registered medicines. This process was implemented in two stages:
- notifications to registered non-prescription medicines, launched in July 2017
- notifications to biologicals and prescription medicines, launched in December 2017.
The new notifications processes are part of our improved risk-based approach to the management of variations.
Under the notifications process, an applicant uses an electronic form to request that certain types of changes be made to their medicines. For registered medicines, the request is automatically processed once it has passed electronic validation and the relevant fee has been paid. Manual processing is still required for notifications to biologicals.
Comparable Overseas Regulator report-based process
In January 2018, we implemented the Comparable Overseas Regulator report-based process for prescription medicines, replacing the Category 2 application process.
Report-based applications can relate to all types of new prescription medicines, including new chemical entities, new fixed dose combinations, generic medicines, biological medicines and biosimilars. This process can additionally be used for variations to existing medicines, including extension of indications or new dosage forms and changes to Product Information documents that would normally require evaluation of clinical data.
Fourteen priority review determinations and two provisional determinations were approved under the new priority review pathway and the new provisional approval pathway respectively. Of the 14 medicines receiving priority review determination, five were also approved for registration in 2017-18. The median timeframe for these registrations via the priority review pathway was 98 working days, against a target timeframe of 150 working days.
Eleven orphan drug designations were approved in 2017-18 under the reformed orphan drug program, with five additional designations approved under the previous orphan drug program (where the designation application was received prior to 1 July 2017). Twenty-one orphan drugs were approved in 2017-18, including one that received its designation under the reformed program.
A new prescription medicines minor variations form was also introduced, providing a single electronic form allowing sponsors to apply for minor variations.
The total number of new medicine applications received was substantially higher than in 2016-17, with increases in the numbers of lower risk (N1, N2 and N3) and higher risk (N5) applications. The total number of applications received to vary existing medicines also increased substantially. The number of negligible risk (C1) applications decreased but was largely offset by the number of negligible-risk (CN) applications received (new notification application type implemented on 1 July 2017). The number of low risk variation (C2) applications increased substantially, in part due to receipt of applications for changes to labelling for compliance with the new labelling Order (Therapeutic Goods Order No. 92). The numbers of higher risk variation (C3 and C4) applications were consistent with previous years.
Median approval times for all new medicine application types were shorter than in 2016-17, but were consistent with previous years. Median approval times for higher risk variation (C2, C3, and C4) applications were longer than in 2016-17. For C2 applications this can be attributed to the large increase in the number of C2 applications received. Four out of five approved C3 applications were within target time and for all other application types the percentage of applications processed within target time continued to be at or close to 100%.
The number of new listed medicines on the ARTG increased by 211 in 2017-18. This may be partly attributed to the introduction of permitted indications in March 2018.
The number of post-market compliance reviews completed decreased in 2017-18 due to a large and complex targeted review project of listed sunscreens having been undertaken over the course of the year. Investigations, which arise from complaints from the public, industry referrals and adverse event reporting, decreased. Investigations are assessed using a risk prioritisation system, and where required, will give rise to a compliance review being initiated.
Labelling, advertising and evidence continue to be major categories of compliance issues. No products were found to have issues posing a potential risk to consumer safety, compared with 22 products in 2016-17.
The number of new and variation applications has stabilised. The number of Technical Master File variations has decreased significantly over 2017-18, back to expected levels. The spike in numbers during 2016-17 was the result of major process alignment activity completed by the public cord blood banks during that year. The first Class 4 biological applications, representing a new class of therapeutic goods were received.
Medicine and vaccine adverse event reports
The total number of medicine and vaccine adverse event reports rose by 1,882 from 2016-17. The mean number of reports received weekly rose from 380 to 416 and the proportion of reports received from each category of reporter broadly matched 2016-17. The transition to a new Adverse Event Management System was initiated on 22 June 2018.
Medical device conformity assessment
The number of Conformity Assessment applications received during 2017-18 significantly increased compared with numbers submitted in 2016-17. We completed 273 applications compared with 204 in 2016-17, and have continued to refine and develop new guidance for industry which is resulting in better submissions and improved application processing.
Medical device incident reports
Medical device adverse event reports received increased by 452 in 2017-18. Media attention and the Senate Inquiry into transvaginal mesh accounts for an increase in reports by patients and carers, while continued education of health professionals on the value of reporting adverse events has led to an increase by them and sponsors.
The number of new export medicine listing applications and variations remained constant over the last two reporting periods. The number of export certificates for medicines increased by 14%, having dropped by 25% in 2016-17. There was again an increase in the number of device certificates issued (22%).
All human blood and tissue permits were released within the 24 hour target timeframe to ensure that emergency demands overseas were met.
Access to unapproved therapeutic goods
A notable change for this reporting period was the introduction of the aforementioned Special Access Scheme (SAS) pathway – Category C. There were 14,560 Category C notifications for medicines which resulted in sizeable falls in the other two SAS pathways. Overall there was a net decrease of 564 SAS notifications/ applications in 2017-18 with decreases observed for medicines and biologicals, and a small increase for devices compared to 2016-17.
Medicines and biologicals manufacturing
The number of inspections of Australian manufacturers increased by 25 in 2017-18 due to the number of new licence and variation applications received, as well as the number of re-inspections performed. The number of initial inspections conducted within 3 months of application for Australian manufacturers increased from 85% to 96%, which is due to manufacturers being ready for the inspection and the prioritisation of these inspections within the target timeframe. Similarly, re-inspections of Australian manufacturers conducted within 6 months increased from 61% to 72%, due to the prioritisation of these inspections to occur within the target timeframe. The number of inspections conducted for overseas manufacturers increased from 58 to 84, due to the number of re-inspections conducted.
Demand for Good Manufacturing Practice (GMP) clearances remained high with 5,327 applications received during 2017-18 compared with 5,471 in 2016-17. The decrease of 144 applications correlates to the decrease in rejected applications indicating an improvement in the quality of applications received. This is attributed to increased educational activities conducted by the TGA.
Overall, the total number of recalls remained steady. There was a slight decrease in the number of medical device recalls, but a notable increase from two to 25 recalls for biological products. This may be attributed to increased stakeholder awareness of the overall regulatory framework for this product category.
A revised risk based process for targeting products for testing was implemented in 2017-18. The revised process resulted in improved accountability and transparency for the testing performed by the Laboratories Branch which is evidenced by the significant increase in the number of individual products tested this year. An increase was also seen in the number of complementary medicines tested as a result of improved targeting of products with a higher risk of non-compliance.
The first testing campaign under the Pacific Medicines Testing Program commenced in the second half of the year. The campaign included five Pacific Island Countries and focussed on antibiotics, paracetamol, and medications for diabetes and cardiovascular disease.
Compliance and investigation and matters increased by 3.2% in 2017-18, with 2,982 matters completed. The largest contributor to the number of matters handled and investigated continues to be referrals from Australian Border Force in relation to the importation of unapproved prescription medicines.