The events, detailed here , will cover updates to the approval requirements for biologics, including the clinical trial data required for review, as well as providing guidance on all other aspects of dossier submission.

The Therapeutic Good Administration (TGA) launched the framework on biologics in May to differentiate such products from traditional medicines, whose production methods make them less of a risk in terms of disease transmission.

The biologics framework also makes provisions for the emergence of new manufacturing processes and production technologies.

At the time the organisation said: “The new framework will provide improved clarity by applying different levels of pre-market regulation to biological products based on the risks associated with the use of each product. In addition, the framework has been designed to be flexible to accommodate emerging technologies.”