Who we are
The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products. The overarching legislation we administer is the Therapeutic Goods Act 1989.
Most products for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before being supplied in Australia. Any product entered on the ARTG may be sampled by our Laboratories Branch and subjected to testing.
The TGA Laboratories perform a range of activities to ensure therapeutic goods are of an acceptable standard. Although our primary activity is to perform laboratory testing of therapeutic goods, we also:
- provide scientific expertise to assess technical data for the registration and inclusion of therapeutic goods on the ARTG
- review manufacturing and testing data from companies to ensure the standards required for inclusion in the ARTG are maintained and check that individual batches of vaccines and selected biological products comply with approved specifications before batches are released to the market
- provide administrative, scientific, and engineering advice to the TGA, expert committees, government, industries and consumers
- provide technical expertise for developing and maintaining national and international standards (for example, through ISO, EDQM and WHO)
- deliver training in testing techniques and other relevant regulatory functions.
How we decide what to test
Our laboratories test therapeutic goods and other things in a variety of circumstances, including in the four key ways outlined below.
In recent years, the Laboratories Branch has tested around 2100 samples per year, including prescription medicines, non-prescription medicines, Over-the-Counter (OTC) and complementary medicines, medical devices, other therapeutic goods and unregistered products. Samples for the testing program are obtained from a wide range of sources including sponsors, manufacturers, wholesalers, chemists, hospitals, retail outlets, and consumers.
There are four key components of the testing program:
Responsive testing
This type of testing takes priority to ensure timely management of potential public safety issues. Goods which have been associated with an event, such as a complaint or adverse event investigation, may be selected for testing.
Also included under this category is the majority of our laboratory testing of unregistered therapeutic goods. Unregistered products are generally tested to determine if they contain any undeclared pharmaceutical ingredients or other prohibited substances.
Programmed testing (compliance and monitoring)
Goods on the Australian market may be selected for compliance and monitoring testing to verify that they meet quality or performance requirements as defined by official standards or agreed specifications. This testing is governed by a risk management framework which is based on ISO 31000 - Risk management - principles and guidelines. Our testing program is developed to ensure that our work is focussed on current and upcoming areas of concern, and where laboratory testing can provide the greatest value.
Maintenance testing
The maintenance testing category is a long term, supporting activity which is essential to ensuring the responsiveness, robustness and reliability of the overall testing capability of the TGA. As a Commonwealth testing facility, we maintain NATA (National Association of Testing Authorities) accreditation to AS ISO/IEC 17025-2017 General requirements for the competence of testing and calibration laboratories, and we carry out some testing activities to maintain this accreditation. We also participate in international collaborative studies and in the calibration of reference materials for use as standardised test controls.
External testing (Laboratory support to external agencies)
At various times, we provide testing, training services and advice to other national regulatory authorities, international organisations and Australian government departments.
The Laboratories Branch is designated as a WHO Collaborating Centre for both Medicines Quality Assurance, and the Quality Assurance of Vaccines and other Biologicals. The branch is also designated as an Essential Regulatory Laboratory, which gives us responsibility for ensuring the availability of the reagents for the manufacture of seasonal influenza vaccines.
A major project that the Laboratories Branch has undertaken is the Pacific Medicines Testing Program (PMTP). The Australian government, through the TGA and the Department of Foreign Affairs and Trade (DFAT), provides access to Australian laboratory testing for medicines quality assurance for 13 participating countries (including 12 Pacific Island countries and Timor-Leste) through this Program. Medicines are tested by our Laboratories Branch with funding provided by DFAT.
The PMTP focuses on the testing of medicines for non-communicable diseases (such as medicines for heart disease and diabetes), as well as antibiotics, COVID-19 related products (such as face masks) and oral liquids to be screened for the presence of diethylene glycol and ethylene glycol (DEG/EG). Participating countries can also send medicines to the TGA when there is a problem or a complaint. The testing services provided are at no cost to participating countries.
How we test
Testing measures the compliance of a particular sample against specified quality criteria. For regulated products, the quality of the sample is assumed to represent the batch from which the sample is drawn, providing there are assurances that the sample has been stored in accordance with label instructions. However, the samples tested may not be representative of other batches of the product. For this reason, laboratory testing cannot be seen as a replacement for other regulatory controls (such as Good Manufacturing Practice (GMP) compliance, and assessments for market authorisation).
If therapeutic goods have been obtained by the TGA in an applicable way, testing will be conducted under Part 5 of the Therapeutic Goods Regulations 1990 (the Regulations). This sets out a particular set of procedures to be followed by the TGA concerning sample storage, handling and analysis. Regardless of whether testing is conducted under or outside of Part 5 of the Regulations, the integrity of our laboratory testing is maintained by our Quality Management System (QMS) and associated laboratory operations manuals and standard operating procedures.
The QMS is audited by the independent body the National Association of Testing Authorities, Australia (NATA). Systems are in place to track samples and ensure their appropriate testing. All laboratory testing is recorded and monitored by a Laboratory Information Management System (LIMS).
Therapeutic goods supplied in Australia must comply with applicable standards and other requirements. For most medicines these are 'default standards' provided by the British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia - National Formulary. In some cases specific Australian standards may apply, known as Therapeutic Goods Orders (TGOs).
For those medicines that do not have a pharmacopoeial monograph or TGO, specified acceptance limits are agreed mutually and recorded as the product's Certified Product Details with which the product must comply. Medical devices are tested to ensure they perform as expected and in accordance with the Therapeutic Goods (Medical Devices) Regulations and the Essential Principles.
What we do with our results
The findings of laboratory testing provide an immediate assessment of the portion or sample tested. This assessment regularly includes analysis of the quality, safety or performance of the portion of sample tested, which may be extrapolated to the batch of the tested therapeutic goods. This information is useful in supporting and informing regulatory measures.
When laboratory testing identifies problems with therapeutic goods, that information is provided to our regulatory decision-makers. We may also liaise directly with product sponsors to identify the best course of action. Our response varies in accordance with our risk-based approach to regulation.
When we identify serious quality, safety or performance issues with therapeutic goods, information and recommendations are ordinarily posted immediately on the safety information pages of our website. Actions that may be taken include requiring changes to be made to the product labelling, monitoring the product over time to identify further issues, or recalling the product.
In mid-2017 we began publishing information about our laboratory activities, including outcomes of laboratory testing, on our website. This aligns us with other key regulators who publish similar information such as the U.S. Food and Drug Administration and the European Medicines Agency. Publication of laboratory test results does not replace mechanisms for providing timely alerts to healthcare professionals and consumers where a serious safety or quality issue has been identified. We continue to release timely information about safety concerns on our safety information website pages.