The Therapeutic Goods Administration (TGA) has launched a new initiative - the Early Scientific Advice service - that enables applicants to request scientific advice on specific data before they apply to register a medicine.
To register a medicine for supply in Australia, applicants must demonstrate that the medicine meets legal standards for safety, quality and efficacy. Access to the Early Scientific Advice service will help companies to prepare scientifically sound data to support their registration application.
In 2020, therapeutic goods legislation was changed to allow the TGA to provide scientific advice on higher risk medicines. Initially, this service will provide advice to applicants on 'biowaiver' justifications. A biowaiver is an internationally recognised concept allowing reduced data to be presented to show that one medicine is bioequivalent to another medicine - this means that the same amount of an active ingredient is absorbed by the body over the same period of time.
While there is a range of information on the TGA website to help companies understand what data is needed to show bioequivalence, the highly technical nature of these requirements means it may not always be clear whether specific data would support a biowaiver justification. Applicants may invest considerable time and resources into developing data that is not needed, or may leave out data that is needed. In either case, this may delay access to new medicines for consumers.
In these situations, the Early Scientific Advice service can help applicants to reduce their costs associated with developing their product.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.