The Australian Pesticides and Veterinary Medicines Authority (APVMA) has published a guideline for the evaluation of efficacy 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We consulted on the draft guidance document between November 2024 and January 2025. A total of 3 submissions were received from industry groups, and the feedback was considered in the development of the final guideline.
Questions about the guidance document can be directed to enquiries@apvma.gov.au