This consultation closed on 20 January 2025
Background
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is seeking feedback on its draft guideline for the evaluation of the efficacy and safety of non-steroidal anti-inflammatory drugs (NSAIDs).
This guideline has been developed to specify recommendations for the design, conduct, and evaluation of clinical studies for NSAIDs to be provided in support of an application to register a new NSAID, or to vary the indications of an already registered NSAID. It provides recommendations on how to appropriately demonstrate clinical efficacy through clinical trials where the selection of control and efficacy endpoints is regarded as a key issue for obtaining conclusive information. The guideline also includes safety aspects when studies are undertaken to assess efficacy.
We invite submissions from 1 November 2024 to 20 January 2025 on the draft guideline for the evaluation of the efficacy and safety of non-steroidal anti-inflammatory drugs.
Please note: Submissions will be published on the APVMA’s website, unless you have asked for the submission to remain confidential (see public submission coversheet).
Submissions received
The APVMA sought feedback on draft guideline for the evaluation of the efficacy of non-steroidal anti-inflammatory drugs, in a consultation that closed on 20 January 2025.
A total of 3 submissions were received from industry groups.
A copy of published submissions is available on our website.
Consultation feedback
The APVMA is currently considering all submissions received as part of this consultation.