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.
A guideline on how to access this service is published by TGA for prospective sponsors who:
- are preparing an application to register a medicine for oral ingestion
- wish to seek the TGA’s advice on a biowaiver justification
- can provide data in support of the biowaiver justification as an eCTD submission.
This guidance outlines how to request early scientific advice on data to support certain biowaiver justifications, which may assist in preparing a scientifically sound dossier to support an application for medicine registration.
Early scientific advice from TGA is not legally binding on the TGA or on the medicine developer. However, if a subsequent application for registration is submitted, the delegate within the TGA must have regard to the advice when making the decision to approve the application.
For more information, please refer to https://www.tga.gov.au/new-early-scientific-advice-service-support-medicine-registrations & https://www.tga.gov.au/publication/early-scientific-advice