#1Spotlight on Australia Life and Health Sciences Invest Northern Ireland#2Suzanne McMillan Regional Senior Manager, Trade and Investment, Australia and New Zealand, Invest NI Invest Northern Ireland#3Welcome *Welcome to Australia everyone we are open for business! * Australia is a market that offers transparency in its Life and Health Sciences regulations, commitment to research and clinical trials, and is investing in digital health infrastructure and product, and welcomes international collaboration *Today, the webinar will feature an expert panel of speakers addressing: - Market opportunities - Logistical and compliance issues - Commercial opportunities Finally, we will have a Q&A session at the end; where we can answer your immediate questions and hopefully whet your appetite for exporting into Australia Invest Northern Ireland#4Angela Foley Founding Director of Foley & Associates Pty Ltd Invest Northern Ireland#5SPOTLIGHT ON AUSTRALIA LIFE AND HEALTH SCIENCES FOLEY & ASSOCIATES PTY LTD | SYDNEY (AUSTRALIA) www.foley.net.au#6Australia in 2023 World's largest economies, 2023 Percentage share of total world nominal GDP in US$ 4. Germany 4.1% 14. Russia 1.5% 19. Saudi Arabia 0.9% 1. US 24.1%, 18. Netherlands 1.0% 3. Japan 4.8% 5. UK 3.3%, 15. Spain 1.4%. 8. Canada 2.1%- 2. China 19.7% 11. Korea 1.7% 13. Iran 1.6% 7. France 2.8% 20. Taiwan 0.8% 17. Mexico 1.2% 9. Italy 2.0% 6. India 3.2% Source: Austrade Benchmark Report 2022 ASEAN 5.3% (includes 16. Indonesia 1.3%) -16. Indonesia 1.3% 12. Australia 1.7% 10. Brazil 1.8% Australia set to become the world's 12th largest economy in 2023. Australia's population accounts for 0.3% of the world's population but she accounts for 1.7% of the global economy Equates to A$2.5 trillion (~£1.7 trillion) nominal GDP for 2023.#7Indonesia Australia Saudi Arabia New Zealand US Korea Nigeria Australia's Resilience Expected change in real GDP¹, selected economies Percentage change from 2019 to 2022 7.0 6.7 6.5 6.3 5.9 5.8 5.3 5.1 4.0 3.0 2.8 2.1 1.9 1.6 1.4 1.3 1.1 ASEAN-5 Netherlands Canada Malaysia European Union LATAM² Philippines Brazil France UK Germany South Africa 0.2 0.1 Advanced economies = 3.7% -0.6 -0.8 -1.5 -1.7 -1.8 Growth rate expected to remain strong at 4.2% in 2022 (following a solid rebound of 4.7% in 2021). GDP predicted to be 6.7% larger by the end of 2022 than in pre-pandemic 2019 This increase over the pre- COVID-19 level in 2019 is higher than the average for advanced economies (3.7%). Source: Austrade Benchmark Report 2022 Japan Italy Thailand Spain Mexico Russia#8| (T) ՏՈ UK (2) China (3) Germany (4) France (5) Source: Austrade Benchmark Report 2022 Canada (6) Japan (7) 12,785 3,576 3,183 1,729 Switzerland (8) 3,139 1,481 1,345 Australia (9) Australia is a top 10 contributor to life science h Health research by country¹ Life science² count index, 1 September 2020. - 31 August 2021 1,263 1,207 Sweden (12) Israel (15) 841 541 Korea (16) 481 338 Singapore (19) Norway (20) 319 298 293 Finland (21) Brazil (22) India (23) 244 Russia (25) 217 New Zealand (30) 145 48 UAE (44) According to an index published by 'Nature': Australian researchers & institutes published 1,207 academic articles in accredited journals (2020-21). Note: number in brackets = country's ranking across 162 economies.#9Australia - 'a thriving life sciences hub with a global reach' Strong Financials • Life sciences companies raised A$1.7bn (£1bn) in Australian equity capital markets in 2020. 185+ ASX listed life sciences companies with a combined market cap of A$300bn (£170bn). Life sciences and healthcare exports worth over A$5.6bn (£3.2bn) in 2021. Global Large-Caps The ASX is home to some of the world's largest and most influential healthcare and life sciences Co ani Cochlear CSL SONIC HEALTHCARE RAMSAY HEALTH CARE Fisher & Paykel HEALTHCARE • Australia's Life Sciences Sector Healthy Banks & Capital Markets Australia has several investment and commercial banks, as well as investment funds that actively service the life sciences sector. MACQUARIE AustralianSuper Commonwealth Bank BARCLAYS J.P.Morgan HSBC Government & Industry companies (1,017) regulatory organisations (129) Research institutes (189) Support services (485) Pharmaceuticals (340) Medtech & digital health (387) Food & agriculture (290) Source: ASX, AusBiotech, Australian Trade and Investment Commission. 86% of industry companies are SMEs#10Australia's Digital Health & MedTech Ecosystem State/Territory Government Health Agencies Tasmanian Government NORTHERN TERRITORY GOVERNMENT Department of Health Government of South Australia SA Health eHealth Queensland Queensland Government Government of Western Australia Department of Health ACT VICTORIA Health Government NSW GOVERNMENT eHealth State Government and Human Services Health Federal Government Agencies Australian Government National Health and Medical Research Council NHMRC Australian Government Department of Health TGA Australian Government Australian Digital Health Agency Australian Government Australian Institute of Health and Welfare Industry Associations / NGOs Australasian TELE HEALTH MSIA MEDICAL SOFTWARE INDUSTRY ASSOCIATION Australian Government Department of Health Therapeutic Goods Administration CYSTIC FIBROSIS Australia Society MTAA Medical Technology ASSOCIATION OF AUSTRALIA AICH Heart Foundation AUSTRALASIAN INSTITUTE OF DIGITAL HEALTH aiia australian information. industry association ACSA Aged & Community Services Australia Mental Health Australia diabetes australia Australian move muscle, bone & Joint health RED ALZHEIMER'S RESEARCH Foundation ACIITC Aged Care Industry Information Technology Council 6HCF Private Health Insurance Providers nib Bupa Australian Unity ed by slingshot catalyst 6 HCF medibank AQBE AH Australian Health ACCELERATOR Healthcare Providers (Hospitals, Aged Care) AlfredHealth Healthscope Ramsay Health Care Bupa Uniting Care regis aged care esh ST VINCENT'S HEALTH AUSTRALIA Private Companies medAdvisor® Pacific PHILIPS Health Epworth Knowledge Systems Healthcare EGE Healthcare episoft Epic DEVICE ALCIDION COVIU TECHNOLOGIES Medtronic curve specialist aged care medtech* Oneview Cochlear perx Baxter Cerner PainChek Roche VITALIC MEDICAL Intelligent Pain Assessment ResMed Opal Allity Estia Health Growth Centers & Accelerators לבן Planet Innovation cicada INNOVATIONS MEDTECH ACTUATOR MTP Connect MedTech and Pharma Growth Centre * ANDHealth Australia's National Digital Health Initiative#11Health System VICTORIA State Health + Government and Human Services Healthscope RAMSAY Queensland Government 761 466 HEALTH CARE SOUTH Public Government of South Australia NSW SA Health GOVERNMENT Health 1,227 Operating hospitals Private Epworth Complex matrix of public & private providers: The public health system: Public hospitals, community-based services and affiliated health organizations predominantly owned and operated by state & territory governments; The private health system: Privately owned & managed health service providers e.g., private hospitals, specialist medical and allied health and pharmacies. The Royal Children's Hospital Melbourne Royal Prince Alfred Hospital Highly regulated environment: Australian Government State & Territory Governments Local Governments COAG HEALTH COUNCIL Responsibilities Shared by the Council of Australian Governments (COAG)#12End Buyers and Procurement Process - Commonwealth Government is the major source of funding for Australian healthcare, contributing -41% of funding State and Territory Governments contribute -26% of funding Private individuals contribute -~A $28.6 billion (~£15.6 billion) out-of-pocket for purchasing health services Public hospitals account for 70% of medical device procurement and private hospitals account for 30% Invest Northern Ireland Government Procurement Process (usually state or territory level) Government agencies publicly issue a Request for Tender on govt tender websites Government procurement regulated by Commonwealth Procurement Rules. State & Territory governments also have their own procurement policies. Private Sector Procurement Process Private companies rarely publicly advertise Negotiate directly with an established network of suppliers Participation in private sector tenders is often by invitation only and may not be publicly advertised Could be challenging for NI exporters to participate without in-country partners. 12#13Federal Health Budget 2022-202** Australian Government Department of Health Health • A$2.6bn over 2 years for the . procurement & distribution of RATS & PPE • A$1bn over 2 years to support the Government's emergency response to COVID-19 • A$892.1m over 2 years to continue the health response to COVID-19 pandemic • A$375.6m over 4 years to contribute to the establishment of Western Australibata CASpensive Cancer Centresia.Borth Industr ☑ .y • • Medical Medical Resedic Puture Fund (MRFF) A$2.1bn over 10 years from 2022-2023, for medical translation to support medical discoveries becoming part of medical practice. A$1.4bn over 10 years from 2022- 2023, to support patients by funding innovative treatments, supporting clinical trials, and delivering more advanced health care/medical tech. Total A$3.5bn (£2.0bn) A$750m boost to the Modern Manufacturing Initiative A$53.9m for Round 3 of the Manufacturing Modernisation Fund Total A$804m (£452m)#14New South Wales State Budget 2022- 2023 Health Services and Infrastructure - Major Spending Activities Workforce A$4.5bn (£2.5b) invested in NSW Health workforce to recruit over 10,000 FTE staff to hospitals and health services across the state. ** NSW GOVERNMENT Health Mental A$4058m) for the Integrated Mental Health Complex at Westmead (Sydney). Ambulanc A$1.8bm (£1.0b) to enable NSW Ambulance to recruit over 2,000 staff and open 30 new ambulance stations between 2023 and 2026. Triage and Telerem) to provide in-house Secondary Triage & Alternative Referral Services within a new Ambulance Virtual Clinical Coordination Centre. Resilience A$776.7m (£437m) for Health Service resilience programs. Children's Hospital A$185.4m Redevelopmen for Children's Hospital at Westmead Redevelopment (Sydney). Palliative A$74417m) over 5 years to enhance end- of-life palliative care services. Health and Academic Precinct A$126.8m (£71m) in 2022-2023 (as part of a A$740m project) for the Liverpool Health & Academic Precinct (Sydney).#15New South Wales State Budget 2022- 2023 NSW GOVERNMENT Health Health Services and Infrastructure - Continued $ Biomedical A$15Amc@Beatdor the Biomedical Accelerator Complex in Camperdown (Sydney). RNA Therapeutics A$119.1 Manufacturing years in ribonucleic acid (RNA) therapeutics manufacturing, research and development initiatives. Viral Vector Manufacturing A$49.6m (£28acbiep develop and test life-saving therapies for rare genetic diseases and cancers. Future Economy Fund (investing in science and Commercializatio A$342.4m (£192m) to boost support for the commercialization of products, services and emerging digital technologies. Growth and A$219esto accelerate growth and investment in priority industry sectors including medtech. R&D and A$1mation to drive R&D and innovation growth in sectors in which NSW has a natural competitive advantage, including life sciences and clinical trials.#16Opportunities for NI Exporters - Traditional • • • Healthcare expenditure (% of GDP) expected to double over next 50 years. Aged care is a priority: Australia's older population expected to double by 2057. Total market for medical devices valued at >£3.8 billion (Medical Technology Association of Australia). > 54% of companies active in the sector are SMEs Australia imports 80%+ of medical devices used in the market (~32% from USA) OPPORTUNITIES FOR NI EXPORTERS: All levels of government are committing funds towards: healthcare resources, new infrastructure, boosting telehealth & mental health support capabilities: WA NT SA NS W VIC VIC Victoria: A$2.5 billion (£1.4b) in health, mental health & aged care infrastructure in 2022-23 budget. New South Wales: A$10.1 billion (~£5.7b) to health infrastructure through 2022-23 including 40+ new / upgraded hospitals. SUPPLY OF EQUIPMENT/TECHNOLOGY/SERVICES TO TREAT CORONARY HEART DISEASE, STROKE, DEMENTIA, LUNG CANCER, COPD, BREAST CANCER, PROSTRATE CANCER, DIABETES ORTHOPAEDIC & PROSTHETIC MARKET FASTEST GROWING SECTOR (AGING POPULATION) TAS#17PHILIPS 1& HEARTSTARY ASS Future Areas of Demand... - - - Smart medical devices - the new frontier - Integrating digital technologies into traditional devices to improve value proposition ↑ in health technologies & devices using advanced material/robotics/adaptive diagnostic technology platforms etc. Smart monitoring devices & diagnostics and the algorithms that interpret the data - - Biosensing wearables such as digital blood pressure monitors, glucose sensors to support telehealth Better wearables for high-risk industries (mining) & ingestible smart devices & biosensors Point-of-care and home diagnostics are also key drivers of market demand Robotic Surgery - Use of a camera arm and mechanical arms to view the surgical site in high- definition, magnified 3D images on a computer Digital Therapeutics - Including emerging technologies such as virtual reality and online therapies to assist people to adopt healthy behaviours and social robots Artificial Intelligence (AI) - Al-enabled chatbots which support patient screen prior to physician assessment Use of computer aided diagnosis to assist with interpreting medical images PATIENT, JOHN D. DOB-7-31-1 7-31-1954 ADM 02-1 A02-12-2010 DOCTOR FUNGUSON ACCT 2087419342 MEDICATION ALERT#18Digital Health Overview Australia's digital health infrastructure is underpinned by: medicare digital health Australian Government Australian Digital Health Agency INFRASTRUCTURE Australian Digital Health Agency · MyHealth Record System connectivity E-prescriptions Workforce education CAPABILITIES CRC Invest Northern Ireland ANDHealth Australia's National Digital Health Initiative Digital Health CRC • PhD development Data analytics and insights Translational science ANDHealth Startup-to-scaleup ↑ STEM jobs ↑ Patient impact ↑ Clinical trials ↑ Capital ↑ Exports INDUSTRY COMPANIES 18#19Digital Health (digitalthealth.gov.au) National Digital Health Strategy - Strategic Priority Outcomes (..to Health information that is available whenever and wherever it is needed Health information that can be exchanged securely High-quality data with a commonly understood meaning that can be used with confidence Better availability and access to prescriptions and medicines information Digitally-enabled models of care that improve accessibility, quality, safety & efficiency Workforce confidently using digital health technologies to deliver health and care Thriving digital health industry delivering world-class innovation Industry Perspectives • MyHealth Record • Ensures individual and community confidence in digital health systems and infrastructure • Interoperability of clinical data across health service provision - essential to high quality sustainable healthcare . • Access to views of your prescribed and dispensed medications via MyHealth Record - requesting medications on-line etc. • . • Integrating digital solutions across acute & emergency, paediatric, aged & palliative care. • Training is critical to ensure effective use of digital health solutions Provide developer tools and services to enable innovation in digital health. "Health does not lack innovation, HCF the issue always is in scalability, and execution in a fragmented system" ☑ Pharmaceutical Society of Australia "Technology on its own...no matter how effective the platform, will not bring about changes in the behaviours of clinicians."#20Key Opportunities - Digital Health Invest Northern Ireland IN DEMAND: Solutions that address Australia's major healthcare challenges CURRENT CHALLENGE Over Dependence on In-Patient Care Resource Utilization Effective Chronic Disease Management Improving Home Care Support OPPORTUNITIES FOR NORTHERN IRISH COMPANIES Telehealth/telemedicine, ambient sensors, home monitoring, wearables (quantified self). Technologies that improve healthcare workflows demonstrate ROI, e.g., radiology IT, RFID tags - Predictive solutions for diagnostics & telehealth, cloud platforms for home care, disease management & patient engagement. Interoperable systems that provide in-home clinical support without compromising the quality and safety of services & patient data. UK TECH IN AUSTRALIA dna nudoe CovidNudge incl. DNACartridge, a disposable/sealed lab-on-a-chip device & NudgeBox, a standalone instrument that runs RT-PCR tests on the spot (at mine sites etc.). Partnered with Pantonic in Aus. unmind App assesses employee wellbeing aiming to optimise wellbeing in the workplace. Offers digital courses, meditation and healthy recipes. Opened a Sydney office. 20 20#21Considerations for Market Entry - - - Invest Northern Ireland Find and qualify and in-country partner or consider aligning yourself with key stakeholders in Australia. Work with an Australian healthcare provider / medical research institute - in collaboration with a local technology partner - to trial the solution in the local environment. Collaboration with private health insurance companies or not-for-profits, aligned with particular diseases, also presents opportunity for market entry. diabetes australia mnd* IN THIS TOGETHER parkinson's Australia AUSTRALIA Potential for cross-cultural collaboration on trials/pilots conducting trials simultaneously in 2 regions broadens outcomes/prevents study bias. 21#22Dr Duncan Macinnis Director of Stakeholder Engagement for New South Wales (NSW) and ACT at MTP Connect Invest Northern Ireland#23MTP Connect MedTech and Pharma Growth Centre Spotlight on Australia | Life and Health Sciences Invest Northern Ireland Dr Duncan Macinnis | Director of Stakeholder Engagement (NSW/ACT) Industry Australian Government Growth Department of Industry, Science, Energy and Resources Centres MTPConnect Championing a sector-led approach to accelerating the growth of the medical technology, biotechnology and pharmaceutical ecosystem in Australia#24MTPConnect's goal is to accelerate the growth of Australia's MTP sector Industry Associations Universities AA Regulators BR Researchers MTP Connect MedTech and Pharma Growth Centre Investors 1 Increasing collaboration and commercialisation across the sector Companies 2 Improved management and workforce skills Governments 3 Optimising the regulatory environment 4 Improved access to global supply chains and international markets#25MTPConnect Programs Overview @$182m Australian Government Industry Growth Department of Industry, Science, Energy and Resources Centres Australian Government Department of Health Medical Research Future Fund Growth Centre Project Fund $15.6M grant value 40 projects $34.8M matched industry contributions (cash and in-kind) $1.2M State Government contributions $205.2 external investment 31 projects completed BioMedTech Horizons PROGRAM BMTH SUPPORTING TRANSLATION OF AUSTRALIAN MEDICAL TECHNOLOGY INNOVATION bTb Biomedical PROGRAM TRANSLATION BRIDGE PROGRAM RED* DEVELOPING AUSTRALIA'S MTP SECTOR WORKFORCE TTRA TARGETED TRANSLATION RESEARCH ACCELERATOR DIABETES CARDIOVASCULAR DISEASE Clinical Translation CTCM &Commercialisation Medtech $45M grant value 46 projects $22.3M grant value 21 projects $32M grant value 13 program partners 31 training programs $47M grant value 7 research projects $19.75M grant value#26MTP Connect WA Life Sciences Innovation Hub In partnership with WA Life Sciences Innovation Hub GOVERNMENT OF WESTERN AUSTRALIA NEW INDUSTRIES WA THE UNIVERSITY OF WESTERN AUSTRALIA Tuesday 30 November 2021 7:30-9:00am AWST Harry Perkins Institute of Medical Research 6 Verdun Street, Nedlands WA MTPConnect WA Life Sciences Innovation Hub In partnership with INDUSTRIES THE UNIVERSITY OF WESTERN AUSTRALIA WA MTP SECTOR SPOTLIGHT SERIES Join our host Dr Tracey Wilkinson for November's spotlight on: Argenica Therapeutics Dr Tracey Wilkinson Director Stakeholder Engagement WA MTPConnect Dr Liz Dallimore Chief Executive Officer Argenica Therapeutics Dr Samantha South Chief Operating Officer Argenica Therapeutics WA MTP Manufacturing $450K Voucher Program MTP Connect WA Life Sciences Innovation Hub in partnership with NEW INDUSTRIES THE UNIVERSITY OF WESTERN AUSTRALIA Congratulations to: • OncoRes Medical Proteomics International • SynGenis • VeinTech VitalTrace TELETHON KIDS INSTITUTE Happy healthy kids Connect nces CASE STUDY: East meets West - The Chemistry of a Perfect Match for SpeeDx and SynGenis Your Oligonucleotide Specialist Oligonuc Diagnostic#27MTP Connect Adelaide Intermediary Program Adelaide BioMed City In partnership with AUS SOUTH Government of TRA South Australia Adelaide Intermediary Program As part of its EXCITE Strategy, the Government of South Australia has invested resources on intermediary functions that drive collaboration and knowledge transfer between researchers and industry in Innovation Districts. MTPConnect has been appointed by the Government as the External Innovation and Translation Intermediary for Adelaide BioMed City (ABMC). Through targeted activities and services, MTPConnect's Adelaide Intermediary Program is focused on growing South Australia's health and medical industry sector by fostering collaboration, strategically building capacity and attracting new talent and opportunity across the research, innovation and translation value chain. MTPConnect appointed MTP Connect MedTech and Pharma Growth Centre INNOVATION INTERMEDIARY for ADELAIDE BIOMED CITY#28Growth Centre Catalyst Bodies Antimicrobial resistance Cardiovascular devices Regenerative Clinical trials Genomics medicine A AAMRNet ACVA CT:IQ InGeNA RMCP#29Australia's R&D Tax Incentive Australia's R&D Tax Incentive aims to: . boost competitiveness and improve productivity across the Australian economy encourage industry to conduct R&D provide business with more predictable, less complex support improve the incentive for smaller firms. to engage in R&D A 43.5% refundable tax offset for eligible entities with an aggregated turnover of less than $20 million per annum. A 38.5% non-refundable tax offset for all other eligible entities (entities may be able to carry forward unused offset amounts to future income years). S %#30Australia as a Clinical Trials Destination Australia is an ideal location for clinical trials with many advantages Sophisticated medical research Rapid approvals environment and robust regulatory framework Quality transferable data Cost-efficient An ethnically diverse patient population#31Australia as a Clinical Trials Destination Proximity to Asian markets backed by Free Trade Agreements Seasonal differences 鹽綠 An ethnically diverse population Globally recognised key opinion leaders in major therapeutic areas Western disease patterns ABC Multi-lingual population#32Australia's Clinical Trials Sector $1.4 Billion 5% in EXPENDITURE from 2015 to 2019 M I 8,000 Jobs 4% in EMPLOYMENT from 2015 to 2019 95,000 PATIENTS PARTICIPATED in 2019 H Approx. 1,880 Trials 7% in TRIALS STARTED from 2015 to 2019 Approx. 5% Share of GLOBAL INDUSTRY SPONSORED TRIALS Note: * As calculated in Clinical Trials in Australia (2017 & 2021) reports#33Australia's Clinical Trials Sector NUMBER OF CLINICAL TRIALS > 5.0% p.a. 2.0K 1.9K 1.9K 1.7K 1.7K 1.5K 2016 2017 2018 2019 2020 2021#34Australia's share of global industry- sponsored trail – by therapeutic area Percentage of all multi-country trials started 100 75 +5.9 -11.6 +4.5 -13.2 (-1.9 +3.0 +4.7 50 -9.4 -4.7 25 2013-15 2017-19 Oncology Respiratory Neurology Infectious Combin- disease ations Cardio- Musculo- Nephr- Ophthalm- vascular skeletal ology ology#35CONTACT US FOR FURTHER INFORMATION PHONE EMAIL GET SOCIAL +61 3 9070 8298 [email protected] Australian Government MTP Connect MedTech and Pharma Growth Centre Join the conversation: @MTPConnect_AUS Follow MTPConnect: in @MTPConnect #MTPConnect #Ausinnovation Industry Growth Department of Industry, Science, Energy and Resources Centres Subscribe on: Apple Podcasts Spotify MTPCONNECT.ORG.AU#36Associate Professor Adrian Bootes MBA, BPharm My Medical Department Invest Northern Ireland#37MyMedical DEPARTMENT REGISTERING MEDICINES AND MEDICAL DEVICES IN AUSTRALIA Pharmaceutical Medical Expertise. Anytime. Anywhere AUSTRALIA | UNITED KINGDOM www.mymedicaldepartment.com#38Australian imports vs exports Australia's Top 20 Manufactures Exports 2019-20 $ % % Rank Commodity (a)(b) million share change 1 Aluminium 3,761 7.2 -11.5 Australia's Top 20 Imports 2019-20 2 Pharmaceutical products (excl medicaments) 3,631 6.9 22.9 Rank Commodity (a)(b) $ million % share % change 3 Copper 3,433 6.6 -12.8 1 Personal travel (excl education) services 33,288 8.4 -28.1 4 Medicaments (incl veterinary) 2,912 5.6 10.8 2 Refined petroleum 21,721 5.5 -13.4 5 Telecom equipment & parts 2,499 4.8 13.8 3 Passenger motor vehicles 19,093 4.8 -11.5 6 Aircraft, spacecraft & parts 2,354 4.5 -7.6 4 Telecom equipment & parts 15,230 3.8 4.4 7 Measuring & analysing instruments 2,043 3.9 35.0 5 Computers 10,398 2.6 6.5 8 Medical instruments (incl veterinary) 1,709 3.3 3.4 6 Freight services 10,363 2.6 2.5 9 Zinc 1,302 2.5 -19.0 7 Crude petroleum 9,474 2.4 -29.4 10 Nickel 1,142 2.2 -31.7 8 Gold 8,812 2.2 59.7 11 Perfumery & cosmetics (excl soap) 1,071 2.0 12.6 9 Professional services 8,291 21 7.4 12 10 Medicaments (incl veterinary) Pigments, paints & varnishes 987 1.9 0.3 8,124 2.0 8.6 13 11 Goods vehicles 2.0 -23.6 Computers 975 1.9 7.0 12 Pharmaceuticals products 14 Vehicle parts & accessories 920 1.8 4.4 (excl medicaments) 6,075 1.5 25.5 15 13 Telecom, computer & information- Paper & paperboard 884 1.7 -13.8 5,952 1.5 24.1 services 16 Civil engineering equipment & parts 813 1.6 11.8 14 Technical & other business services 5,792 1.5 4.3 17 Lead 801 1.5 -13.8 15 Passenger transport services (c) 5,242 1.3 -30.4 18 Specialised machinery & parts 799 1.5 -0.5 16 Charges for intellectual property 4,914 1.2 -2.1 19 17 Furniture, mattresses & cushions Jewellery 680 1.3 19.4 4,828 1.2 -3.3 20 18 Civil engineering equipment & parts 4,453 1.1 -12.4 Starches, inulin & wheat gluten 665 1.3 1.1 19 Plastic articles 4,099 1.0 6.1 Total manufactures exports(c) 52,329 100.0 -3.1 20 Electrical machinery & parts 3,954 1.0 -0.2 Total imports(d) 397,905 100.0 -5.7 MyMedical DEPARTMENT#39Total NAS applications Similarly, different market needs by country: NAS Number of new active substances Numbers approved in 2020 Canada 33 United States Switzerland 36 50 European Union (EU) 35 Australia 27 ►China ? + Japan 31 MyMedical DEPARTMENT#40Timeliness & Predictability of NAS Approvals Approval time (days) Median 25th and 75th percentiles. 800 600 400 200 EMA 0 Hellogg Cup T FDA T PMDA Health Canada Swissmedic TGA Approval year Approval time is calculated from the date of submission to the date of approval by the agency. This time includes agency and company time. EMA approval time includes the EU Commission time. MyMedical DEPARTMENT#41Multiple regulatory and government stakeholders in Australia State and territories Poisons and meds scheduling, pharmacists, hospitals Customs and Federal Police Prohibited imports and exports Office of Gene Technologies Genetically altered products FSANZ Food Standards Australian & NZ Government Supply Tenders State government tendering and contracting TGA Australia Safe, effective use of medicines and devices Pharmaceutical Benefits Schedule Government-subsidised Medicines Benefits Schedule medicines Government-subsidised devices and MyMedical procedures, Drs etc. DEPARTMENT#42The Australian definition of a Therapeutic Good therapeutic goods, means goods: a. that are represented in any way to be, or that are, whether because of the way in which the goods are represented or for any other reason, likely to be taken to be: i. for therapeutic use; or ii. for use as an ingredient or component in the manufacture of therapeutic goods; or iii. for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or b. included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use of a kind referred to in subparagraph (a)(ii) or (iii); and includes biologicals, medical devices and goods declared to be therapeutic goods under an order in force under section 7, but does not include: MyMedical DEPARTMENT#43Four types of therapeutic goods Medicine Products that act by pharmacological, chemical, immunological or metabolic means in or on the body of a human. (includes biological medicines e.g. monoclonal antibodies, vaccines that do not contain human cells, plasma derivatives, recombinant products). • Biological Product made from, or that contains, human cells or human tissues, or live animal cells, tissues or organs and that is used to: Treat or prevent disease, ailment, defect or injury Diagnose a condition of a person Test the susceptibility of a person to disease Replace of modify a person's body parts (unless excluded or regulated as therapeutic goods, but not as biologicals) • After the physiological processes of a person • • 01 02 04 03 Medical Device Any instrument, apparatus, appliance, material or other article intended to be used for human beings for the purpose of one or more of the following: Diagnosis, prevention, monitoring, treatment or alleviation of disease • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap Investigation, replacement or modification of the anatomy or of a physiological process Control of conception. And that that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means. Or an accessory to such an instrument, apparatus appliance, material or other article. Other Therapeutic Goods Product that is not regulated specifically as a medicine, biological or medical device. (includes sterilants, disinfectants and tampons) MyMedical DEPARTMENT#44Therapeutic Goods Types of Supply Allowed Registered Provisionally Registered Listed Listed (A) OR Clinical Trials – Phase I, II, III and IV Special Access Scheme (SAS) - Categories A, B, C Authorised Prescriber Export Listing S19 exemption (personal importation) Vs not TGs Animal testing Lab testing Manufacturing planning MyMedical DEPARTMENT#45MyMedical DEPARTMENT MEDICINES Pharmaceutical Medical Expertise. Anytime. Anywhere AUSTRALIA | UNITED KINGDOM www.mymedicaldepartment.com#467 Pathways for prescription medicines and vaccines 1. Standard pathway 2. Priority pathway 3. Provisional pathway 4. ACSS - Australia/Canada/Singa pore/Switzerland evaluations (now extended to the UK and called ACCESS) 5. Project Orbis - US/Canada/Australia (now extended to additional countries) evaluations for oncology medicines 6. Comparable Overseas Regulator - Pathway A 7. Comparable Overseas Regulator - Pathway B MyMedical DEPARTMENT#47Pre-submission & submission process (local evaluation pathways) Determination/ Designation -Priority Review -Provisional Approval -Orphan Drugs Standard Standard + Orphan Priority Pre-submission meeting Standard Submission for registration Priority + Orphan Provisional Provisional + Orphan Provisional* + Priosity MyMedical DEPARTMENT#48MyMedical DEPARTMENT MEDICAL DEVICES Pharmaceutical Medical Expertise. Anytime. Anywhere AUSTRALIA | UNITED KINGDOM www.mymedicaldepartment.com#49The Regulations NOTIFIED BODY EU MDR-Regulation (EU) 2017/745 IVDD Directive 98/79/EC IVDR- Regulation (EU) 2017/746: Applicable from 26 May 2017 with a 5-year transition period. FDA US Food, Drug and Cosmetic Act of 1938 The Code of Federal Regulations (CFR) Title 21 TGA Australia Therapeutic Goods Act 1989 Therapeutic Goods (Medical Devices) Regulations 2002 Australian Regulatory Guidelines for Medical Devices (ARGMD) MyMedical DEPARTMENT#50Different types and classes of Medical Benefit vs. risk approach Medical devices (not including in vitro diagnostics) Devices I i Class Risk Examples Class I Low Tongue depressors, slings Class - supplied sterile Low- medium Class - incorporating a Some bandages, wound dressings, catheters Medicine cups with defined units measuring function Class lla Intravenous tubing, syringes for infusion pumps Class llb Medium Lung ventilators, medical device disinfectants, some implantable devices (e.g. urethral stents) Class III High Heart valves, devices containing medicines or tissues, cells or substances of animal, biological or microbiological origin Active implantable medical High device (AIMD) Implantable defibrillators MyMedical DEPARTMENT#51Regulatory Routes Australia + EU Medical Devices All Classes ✓ Technical File ✓ Post market surveillance system ✓ Declaration of conformity Class I (sterile & measuring), lla, llb, III ✓ Implementation of a QMS: ⚫ Based on EN ISO 13485 • Include any additional requirements specified in the Regulations ✓ Maintenance of the QMS: Surveillance audits at regular intervals MyMedical DEPARTMENT#52Pharmaceutical Medical Expertise. Anytime. Anywhere MyMedical DEPARTMENT CLINICAL TRIALS AUSTRALIA | UNITED KINGDOM www.mymedicaldepartment.com#53Australian Government Department of Health Therapeutic Goods Administration Australian clinical trial handbook Guidance on conducting clinical trials in Australia using 'unapproved' therapeutic goods Version 2.4, August 2021 TGA The Best Initial Resource for Australian Clinical Trials MyMedical DEPARTMENT#54When to Engage Regulators for Clinical Trials leading up to submission? For innovative medicines: - FDA - US pre investigational new drug (IND) filing EMA - Europe - pre first patient exposure PMDA - Japan - pre first patient exposure (if Japanese, consider sakigake) TGA Australia - after phase 2 or 3 studies - are positive (NB suggest engaging with the EMA/FDA first) For biosimilars: Before phase 3 studies against originator For non-innovative (generic medicines) Before comparator is finalised for comparative studies (country specific?) MyMedical DEPARTMENT#55Key Points 01 TGA follows a European approach 02 230 03 and dossier (ICH, PIC/S, BP/EP/USP are largely accepted, on occasion with Australian additions) Increasing use of international collaboration and reliance pathways for new products and generics. Timelines for prescription medicines are reliable and shortening, improvements for OTCs and devices are still being implemented MyMedical DEPARTMENT#56A/Prof Adrian Bootes Director of Drug Development and Regulatory Affairs W: mymedicaldepartment.com Association of Regulatory and Clinical Scientists (ARCS) Past CEO, Life Member and Certified Fellow in Clinical Research, (retired) Head of The Prescription Medicines Authorisation Branch, TGA MyMedical DEPARTMENT#57Q&A Invest Northern Ireland