09 June 2017
MTPConnect welcomes today’s announcement from the Therapeutic Goods Administration (TGA) of a range of new targeted programs to engage with and support SMEs in navigating regulation and legislation in Australia.
The programs provide dedicated tools and training in five key areas to assist SMEs in navigating the TGA – an area acknowledged by the sector to have been difficult to engage with and understand.
- SME Assist Entry Point – an online entry-point and medicine and medical device information hub for SMEs providing introductions, overviews of pathways and authorisation, and guidance on engaging with the TGA in both pre-market applications and post-market monitoring of products
- Education and training activity – online and face-to-face workshops and presentations to cover topics provided via consultation with the sector, including manufacturing and sponsor obligations
- Decision-trees and other tools – online tools to assist and guide SMEs to identify if products are therapeutics goods, likely pathways to market authorisation, specific regulatory requirements, and classifications for medical devices
- Triage and improved support – a dedicated phone/email support service for SMEs to assist in streamlining pathways through the regulatory process, with greater proactive advice and support
- Data capture – a tool allowing the TGA to easily identify contact from an SME, development of dedicated communications, and a direct channel for SME feedback on services
The TGA will also continue ongoing discussions with the sector to collaborate on further content and topics of interest, and engage key partners from to sector (including MTPConnect) to assist in the delivery of targeted programs.
MTPConnect CEO Sue MacLeman said, “Through extensive consultation with the sector, the MTPConnect Sector Competitiveness Plan identified that many regulatory requirements are not aligned to support small to medium-sized businesses, and are a key barrier in the sector. This announcement from the TGA of SME engagement programs is great news for the sector, and will be vital to ensuring the success of Australian innovations.”
The SME Assist tool is available now on the TGA website - tga.gov.au/sme-assist