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Presentation: Therapeutic Innovation Australia Symposium 2017, 14 December 2017

Introducing SME Assist at the TIA 2017 Symposium

20 December 2017


  • Presented by: Adj Prof John Skerritt
  • Presented at: TIA 2017 Symposium
  • Presentation date: Thursday, 14 December 2017
  • Presentation summary: An Introduction to SME Assist by Adj Prof John Skerritt at the TIA 2017 Symposium


SME Assist

Adj Prof John Skerritt,
Deputy Secretary
Health Products Regulation Group
Commonwealth Department of Health

TIA 2017 Symposium, Thursday, 14 December 2017

Slide 1 - Therapeutic Innovation Australia Symposium 2017

SME Assist

Slide 2 - Background

  • 2013 Productivity Commission report highlighted that small to medium enterprises (SMEs) face challenges in navigating regulatory frameworks
  • National Innovation and Science Agenda -  need to boost the SME subsector in Australia
  • The regulatory process is often neglected by innovators until very late in the product development cycle
  • We need to make the regulation process more easy to understand, and provide better support services for SMEs but to not replace the role of regulatory consultants

Slide 3 - The regulatory framework is complex

  • Therapeutic Goods Act 1989 of 649 pages
  • Therapeutic Goods Regulations 1990 of 278 pages
  • Therapeutic Goods Medical Devices Regulations 2002 of 187 pages
  • And there are also
    • Charges Acts
    • Customs (Prohibited Imports) regulations
    • Dozens of legislative instruments
    • All written in legalese

Slide 4 - Development of SME Assist

  • Consultations undertaken in 2016 with industry organisations, government departments, MTP Connect and in the margins of workshops and conferences
  • Explored international regulatory support (FDA, EMA) models
  • Also "signposting" to other support
  • Launched in June 2017 by Minister Hunt
    • Targets the needs of SMEs
    • Informs therapeutics R&D groups
    • Assists them to meet requirements for local and international markets

Slide 5 - Six components: 1. SME-specific guidance

Covers a range of introductory topics, such as:

  • Basics of regulation
  • Market authorisation
  • When to engage with the TGA
  • Medical devices overview
  • Useful resources

Written in plain English and targeted at SMEs and R&D organisations that have not previously interacted with the TGA

Slide 6 - 2. Education and training

  • Videos and presentations
  • Workshops
    • Meeting Your Obligations: workshops in Melbourne (Aug) and Sydney (Nov)
    • Collaboration with the Dept of Industry's Entrepreneurs' Program
    • Included an overview of medicine regulation, case study examples, Q&A with a panel of experts, and topic-specific breakout sessions
    • Medical Devices Sponsor Information Day targeting the needs of SMEs (Oct)

Slide 7 - 3. Interactive tool

  • Decision trees to better understand the regulation of specific products
    • Is my product a therapeutic good?
    • What classification is my medical device?

Slide 8 - 4. Phone/email support

about 120 enquiries a day!

  • To provide more tailored and efficient assistance to SMEs
  • A massive number of requests are received by TGA annually
  • e.g. from July 16 to June 17:
    • 20,720 phone call requests
    • 7,957 email requests

Slide 9 - 5. Improved data capture

  • Subscription service to keep SMEs up to date
  • Better identifies SMEs and helps direct their enquiries
  • Ongoing investigations into how we can deliver more tailored assistance to SMEs

Slide 10 - 6. Signposting to other services

  • Business support from international regulators
  • Funding opportunities
  • Access to research facilities and training
  • Tools and support for business
  • Subsidy and reimbursement
  • Upcoming events relevant to business

Useful resources for business

Slide 11 - In the first 5 months:

17130 - visits to the SME Assist web page

259 - subscribers, of which 85% are small and medium businesses

2079 - users of the decision tree tools

300 - attendees at workshops

Slide 12 - Regulatory Guidance development

  • Help explain the Therapeutic Goods Act and Regulations to assist industry to understand how to apply them to their product/s
  • In both web-navigable and PDF styles

Recent examples:

  • Special Access Scheme and Authorised Prescriber
  • Pre-submission meetings with TGA
  • Manufacturing licences and GMP certification
  • Medicine minor variations
  • Priority review of prescription medicines
  • Pharmacovigilance requirements
  • Registered complementary medicines
  • Recall Procedures

Slide 13 - Upcoming Guidance documents

Australian clinical trials handbook
Adverse events reporting
Medicines scheduling
Therapeutic Goods Advertising
Release of products for supply
Guidelines for biologicals

Prescription medicines

  • Provisional approval pathways
  • Using reports from overseas regulators

Complementary medicines

  • Permitted indications
  • Permissible ingredients
  • New ingredient assessments
  • Postmarket monitoring
  • Efficacy monographs
  • Variations
  • New pathways

Medical Devices

  • Accelerated assessment
  • Use of overseas regulatory approvals

Slide 14 - Coming in early 2018

Additional workshops and webinars

  • Meeting Your Obligations – more sessions
  • Advertising and making therapeutic claims
  • Regulation of biologicals
  • Manufacturing requirements
  • Medical Devices

Drop-in Days

  • Sessions where SMEs will get 1:1 time with TGA experts

Slide 15 - Coming in early 2018

Researcher – specific guidances

  • Researcher considerations in product discovery and research design
  • Clinical Trials Decision Tree (CTN vs. CTX)

Medicines and Medical Devices Review

  • Means that all areas of the regulatory framework are undergoing major changes
  • So their explanation is even more important

Print version

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