2018 GMP Forum SME Assist Dr Tahli Fenner Director, Regulatory Guidance and SME Support Health Products Regulation Group Department of Health 26 June 2018
Background The review of Medicine and Medical Devices • Regulation (MMDR) highlighted that small and medium enterprises (SMEs) can find navigating the ‘regulatory maze’ a challenge . We need to make the regulation process easier • to understand , and to provide better support services for SMEs and companies in the innovative therapeutic goods industry. • Consultations were undertaken in 2016 – Industry organisations – Government departments 2
SME Assist Launched Friday, 9 June 2017 at the Translational Research Institute, Brisbane by the Hon Greg Hunt, Minister for Health and Sport. � Targets the needs of • SMEs • Those unfamiliar with therapeutic goods regulation � Informs therapeutic R&D groups � Assists them to meet requirements for local and international markets 3
1) Guidance articles Cover a range of introductory topics: • Basics of regulation • Market authorisation • When to engage with the TGA • Medical devices overview • Useful resources (signposting to other services) Written in plain English and targeted at beginners. 4
2) Education and training • Meeting Your Obligations workshops – Five workshops held across Melbourne, Sydney and Brisbane – Supported by the Dept. of Industry’s Entrepreneurs’ Programme – Provided an overview of regulation, case study examples, Q&A with a panel of experts, and topic-specific breakout sessions – Targeted for those unfamiliar to therapeutic goods regulation • Drop in days – First one held in Sydney – Provides select SME’s with individual time with a TGA specialist – Provides better understand on how the 5 regulatory framework impacts their product
3) Interactive tools • Decision trees to better understand the regulation of specific products – Is my product a therapeutic good? – What classification is my device? – Which clinical trial scheme should I choose? 6
4) Phone/email support • To provide more tailored and efficient assistance. 5) Subscription service • Subscription service keeps you informed about what’s coming up and new SME Assist services: • Upcoming workshops and events • New tools and online resources • Webinars 7
Coming soon Meeting your obligations workshops will be held in • Sydney, Melbourne, Brisbane, Perth and Adelaide over the next financial year New guidance material including Introduction to • ingredients and Resources for Researchers 8
As of 30 June 2018: 45,013 visitors to the SME Assist web page 567 Subscribers to SME Assist emails 6,798 uses of interactive decision tools >230 phone and email enquiries answered 226 attendees at Meeting Your Obligations workshops 9
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