Australia Issues Draft Guidance on eCTD Submissions

Australia’s Therapeutic Goods Administration (TGA) released a draft guidance giving drugmakers advice on how to submit regulatory information in the electronic common technical document (eCTD) format. The TGA is working to implement specifications for eCTD finalized last year by the International Conference on Harmonisation’s M2 Expert Working Group and convert to a system in which all data dossiers for prescription drugs are received in electronic format.
International Pharmaceutical Regulatory Monitor