Related Experiment Video
Updated: Aug 6, 2026
04:34
Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia
Published on: February 17, 2023
Listed medicines are rarely assessed for efficacy
1Discipline of Pharmacy, University of Canberra, Canberra, Australian Capital Territory, Australia.
Internal Medicine Journal
|July 17, 2026
Summary
The Therapeutic Goods Administration (TGA) rarely reviews the efficacy of listed medicines, with only 2% assessed in recent years. Furthermore, many medicines use unapproved indications, and random compliance reviews have ceased since 2018.
Area of Science:
- Pharmacovigilance and Regulatory Science
- Drug Efficacy Assessment
- Australian Pharmaceutical Regulation
Background:
- Medicines listed on the Australian Register of Therapeutic Goods require sponsors to declare evidence of quality, safety, and efficacy.
- Regulatory oversight by the Therapeutic Goods Administration (TGA) is crucial for ensuring public health.
- Compliance reviews are a key mechanism for verifying sponsor claims.
Purpose of the Study:
- To evaluate the extent to which targeted TGA compliance reviews (2022-2023) assessed medicine efficacy.
- To document the frequency of random compliance reviews for listed medicines since 2016.
- To identify the prevalence of unapproved indications used by listed medicines.
Main Methods:
- Analysis of 'Issues related to efficacy' sections in TGA compliance review reports.
- Documentation of regulatory matters, including the use of non-permitted indications.
- Systematic review of the Listed Medicine Compliance Review Reports database for random reviews.
Main Results:
- Only 62 out of 215 targeted reviews (approx. 29%) included any efficacy assessment by the TGA.
- Critical appraisal of sponsor efficacy data was detailed in only six reports.
- 33 of the 62 medicines reviewed used indications not permitted under Australian regulations.
- Thirty-seven random reviews were identified between 2016 and December 2018.
Conclusions:
- Recent reliance on targeted reviews means approximately 2% of listed medicines have their efficacy evidence reviewed.
- The use of unapproved indications for listed medicines is a common issue.
- Contrary to TGA documentation, no random compliance reviews have occurred since December 2018.
Related Concept Videos
01:13Bioequivalence studies: Biowaivers
In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
01:09Bioequivalence of Drugs: Drugs with Multiple Indications
The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each indication due to...
01:22Dose-Response Relationship: Potency and Efficacy
The potency of a drug is the measure of its ability to produce a biological response and can be compared by looking at the half-maximum effective concentration or EC50 values of different drugs. A lower EC50 value indicates higher potency of the drug. In the dose–response curve of two antihypertensive drugs, candesartan and irbesartan, a significant difference is observed in their EC50 values. A lower EC50 value for candesartan indicates that it is more potent than irbesartan, as it produces...
01:02Prescription, Nonprescription and Orphan Drugs
Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
01:25Drug Regulation
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
01:30Modified-Release Drug Delivery Systems: Bioavailability
Modified-release (MR) dosage forms are designed to extend drug release over time, thereby maintaining stable plasma concentrations and reducing dosing frequency. However, their bioavailability is typically below 100% due to incomplete drug release and presystemic metabolism, and limitations in drug permeability across the gastrointestinal epithelium, all of which can restrict the fraction of the drug reaching systemic circulation. Consequently, studying the in vivo bioavailability of MR...