Making therapeutic goods safer for everyone

One of the key functions of the Therapeutic Goods Administration (TGA) is to closely monitor the safety of therapeutic goods. This includes medical devices and medicines prescribed by a doctor or available in pharmacies, supermarkets and health food shops.

It’s impossible to know all potential side effects of a medicine or problems with a medical device before it’s approved. There are many variables and some issues will only affect some people.

In addition to the checks and evidence required to register a medicine or medical device, we also keep track of how they perform once available to the public. But to properly monitor medicines and medical devices, we need everyone to report any side effects and problems they have.

If you are worried about an issue that you think might be related to your medicine or medical device, talk to your doctor or pharmacist. You can then ask them to report the side effect or problem to us. Or you can do it yourself. 

This information goes into our Database of Adverse Event Notifications. The database includes all reports, even those where it’s unlikely that a medicine or medical device caused the issue. 

Then, because the raw number of reports alone doesn’t reflect a safety issue, our scientific and medical experts analyse the information. In this way, the database is a valuable tool to help us identify patterns that might reveal potential safety issues.

We look for previously unknown or unrecognised safety issues, as well as a change in the frequency or severity of a known safety issue. We also look to identify new at-risk groups.

When we investigate potential safety issues, we use data from around the world, including from published scientific studies and the World Health Organization, and we may consult with overseas regulatory agencies.

When a safety issue is identified, we assess it to determine its nature, extent and significance. We also consider the balance between the benefits of the product and the potential risks of its use in the Australian population.

There are many things we can do when a potential safety issue is found. The action we take will depend on the benefits and risks of the product.

These include:

• informing health professionals and consumers through alerts
• informing health professionals through our medicines and medical devices safety updates
• changing product labelling, or adding precautions and adverse reaction information to the Product Information (PI) and Consumer Medicine Information (CMI) documents
• changes to the instructions for use of a medical device
• recalling the product or particular batches of the product
• requiring the sponsor to conduct studies about the safety issue.
• withdrawing market approval of the product, or narrowing the population in which it can be used

Reporting side effects and problems helps make medicines and medical devices safer for everyone.