Regulatory compliance framework
The TGA safeguards the health of the Australian community through effective and timely regulation of therapeutic goods. Appropriate regulation helps ensure that the medicines and medical devices that millions of Australians rely on are safe and fit for purpose.
The TGA’s compliance functions support the broader regulatory objectives, including consumer protection, and enable a fair market for industry. We monitor, and enforce where necessary, compliance with the legislation, regulations and rules for therapeutic goods; import, manufacture, advertising, supply, and export.
The work we do is guided by key principles:
- We promote high levels of voluntary compliance by effectively engaging with and educating the regulated community, with clear guidance on how to comply.
- Our compliance and enforcement actions are evidence-based and adjust to respond to the nature and seriousness of the alleged non-compliance, and the potential risk to public health and safety.
- We work with other government bodies, including health and law enforcement agencies, to share information about therapeutic goods, and work collaboratively with them to perform our monitoring and compliance functions.
- We are committed to transparency and reporting on compliance action. The Therapeutic Goods Act 1989 (the Act) allows the TGA to release therapeutic goods information relating to any decision or action taken under the Act or the regulations.
- We undertake our compliance activities with integrity, professionalism and with due regard to procedural fairness.
The TGA has jurisdiction in relation to therapeutic goods and/or products. Other matters such as health services, medical practitioners, or drug offences that fall within the jurisdiction of policing, do not fall within the therapeutic goods compliance framework.
The TGA does not comment on matters under investigation, however where it is in the public interest to do so we will make a public statement on an ongoing matter.
The TGA uses a combination of monitoring strategies to support our compliance programs. Our monitoring programs are both proactive and responsive, including acting upon signals and reports of non-compliance from a number of external sources.
All signals of non-compliance are recorded and considered. We use triage systems across our compliance functions to determine the priority of the matter and how it will be actioned. While the triage criteria can be specific to the particular regulatory requirements and related compliance function, in deciding on a course of action the following will generally be considered:
- the seriousness of the alleged non-compliance and failure to follow the regulatory requirements
- the risk of harm or injury related to a product itself, including the way in which a product is used or being promoted for use
- the indirect risk of harm from reliance on misleading or inaccurate information in lieu of seeking professional health care advice and treatment
- the compliance history and behaviour of the responsible person or business
- the level of compliance of the particular industry sector.
The TGA cannot pursue all matters that come to our attention. We will focus on those matters that concern public safety, allege serious breaches of the Act and regulations, and involve repeated or wilful non-compliance.
A range of compliance and enforcement tools are employed to address alleged non-compliance, either individually or in combination, and to encourage compliance with the Act. These are depicted in the diagram below.
More information on the compliance and enforcement powers provided for under the Act is available, see Compliance actions and outcomes.
Managing regulatory compliance
Further information on specific monitoring and compliance functions can be accessed from the links below.
- How we manage advertising compliance
The TGA undertakes compliance activity and manages reports of non-compliant advertising of therapeutic goods.
- Medicine shortages in Australia: reporting obligations and the TGA's compliance framework
Guidance on the mandatory reporting scheme for medicine shortages and permanent discontinuations of supply of mostly prescription medicines.
- Listed medicine compliance reviews
If we find that a medicine is non-compliant, we take action according to the risk posed by the medicine to ensure the medicine is either brought into compliance or removed from the ARTG.
- Pharmacovigilance Inspection Program
The TGA's Pharmacovigilance Inspection Program (PVIP) has been implemented as an initiative to help sponsors of medicines to meet their pharmacovigilance obligations.
- Medical devices overview
If we find that a safety or performance issue with a medical device we take action according to the risk posed by the medical device to ensure the device is either brought into compliance with the Essential Principles or removed from the ARTG.
Manufacturing therapeutic goods
- Good manufacturing practice - an overview
Good Manufacturing Practice (GMP) describes a set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality.
- Testing of therapeutic goods
TGA Laboratories test therapeutic goods for quality. A risk-based process is applied to determine how products are tested.