GMP Obligations for Small and Medium Enterprises (SMEs): Overview of the SME Assist program

1. 2018 GMP Forum
SME Assist
Dr Tahli Fenner
Director, Regulatory Guidance and SME Support
Health Products Regulation Group
Department of Health
26 June 2018

2. 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
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3. SME Assist
Launched Friday, 9 June 2017 at the Translational
Research Institute, Brisbane by the Hon Greg
Hunt, Minister for Health and Sport.
ü Targets the needs of
• SMEs
• Those unfamiliar with therapeutic goods
regulation
ü Informs therapeutic R&D groups
ü Assists them to meet requirements for local
and international markets
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4. 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.
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5. 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
regulatory framework impacts their product
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6. 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?
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7. 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
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8. 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
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9. 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
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