Definitive global law guides offering comparative analysis from top-ranked lawyers
CHAMBERS GLOBAL PRACTICE GUIDES
Life Sciences 2026 Definitive global law guides offering comparative analysis from top-ranked lawyers
Contributing Editor Lincoln Tsang Ropes & Gray LLP
Global Practice Guides
Life Sciences Contributing Editor Lincoln Tsang Ropes & Gray LLP
2026
Chambers Global Practice Guides For more than 20 years, Chambers Global Guides have ranked lawyers and law firms across the world. Chambers now offer clients a new series of Global Practice Guides, which contain practical guidance on doing legal business in key jurisdictions. We use our knowledge of the world’s best lawyers to select leading law firms in each jurisdiction to write the ‘Law & Practice’ sections. In addition, the ‘Trends & Developments’ sections analyse trends and developments in local legal markets. Disclaimer: The information in this guide is provided for general reference only, not as specific legal advice. Views expressed by the authors are not necessarily the views of the law firms in which they practise. For specific legal advice, a lawyer should be consulted. Content Management Director Claire Oxborrow Content Manager Jonathan Mendelowitz Senior Content Reviewers Sally McGonigal, Ethne Withers, Deborah Sinclair, Stephen Dinkeldein, Vivienne Button and Sean Marshall Content Reviewers Lawrence Garrett, Marianne Page, Heather Palomino, Alison Moore, Adrian Ciechacki and Michael Irvine Content Coordination Manager Nancy Tsang Senior Content Coordinators Carla Cagnina and Delicia Tasinda Content Coordinator Joanna Chivers Head of Production Jasper John Production Coordinator Genevieve Sibayan
Published by Chambers and Partners 165 Fleet Street London EC4A 2AE Tel +44 20 7606 8844 Fax +44 20 7831 5662 Web www.chambers.com
Copyright © 2026 Chambers and Partners
Contents
INTRODUCTION Contributed by Lincoln Tsang, Ropes & Gray LLP p.5
JAPAN Law and Practice p.168 Contributed by Nagashima Ohno & Tsunematsu MALTA Law and Practice p.179 Contributed by Fenech & Fenech Advocates
AUSTRALIA Law and Practice p.8 Contributed by Clayton Utz Trends and Developments p.24 Contributed by Mallesons BRAZIL Law and Practice p.31 Contributed by COSRO Trends and Developments p.52 Contributed by COSRO
MEXICO Law and Practice p.189
Contributed by Baker McKenzie Trends and Developments p.205 Contributed by BC&B Law & Business
NETHERLANDS Law and Practice p.212
CHINA Law and Practice p.58
Contributed by Brande & Verheij LLP Trends and Developments p.229 Contributed by Brande & Verheij LLP POLAND Law and Practice p.233 Contributed by Tomasik Jaworski Sp.p. Trends and Developments p.250 Contributed by DBS Law Firm
Contributed by Global Law Office Trends and Developments p.75 Contributed by Han Kun Law Offices FRANCE Law and Practice p.84 Contributed by McDermott Will & Schulte Trends and Developments p.100 Contributed by Fréget Glaser & Associés GERMANY Trends and Developments p.106 Contributed by D+B Lawyers GREECE Law and Practice p.110 Contributed by ALG Manousakis Law Firm Trends and Developments p.129 Contributed by ALG Manousakis Law Firm
PORTUGAL Law and Practice p.257 Contributed by PLMJ
Trends and Developments p.266 Contributed by MFA Legal & Tech SERBIA Law and Practice p.272 Contributed by BDK Advokati Trends and Developments p.286 Contributed by BDK Advokati SINGAPORE Law and Practice p.291 Contributed by Drew & Napier LLC SOUTH KOREA Law and Practice p.304 Contributed by Lee & Ko Trends and Developments p.316 Contributed by Lee & Ko
INDIA Law and Practice p.135 Contributed by Lakshmikumaran & Sridharan Attorneys INDONESIA Law and Practice p.151 Contributed by Santoso, Martinus & Muliawan Advocates
ITALY Trends and Developments p.164 Contributed by Chiomenti
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Contents
SPAIN Law and Practice p.320 Contributed by Faus Moliner Trends and Developments p.336 Contributed by Faus Moliner SWITZERLAND Law and Practice p.344 Contributed by Bär & Karrer Ltd Trends and Developments p.358 Contributed by Wenger Plattner UAE Law and Practice p.364 Contributed by Covington & Burling LLP Trends and Developments p.379 Contributed by Covington & Burling LLP
UK Law and Practice p.385 Contributed by Arnold & Porter USA Law and Practice p.399 Contributed by Arnold & Porter Trends and Developments p.410 Contributed by Ropes & Gray USA – MASSACHUSETTS Trends and Developments p.417 Contributed by Wiggin and Dana LLP
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INTRODUCTION Contributed by: Lincoln Tsang, Ropes & Gray LLP Ropes & Gray LLP is home to one of the world’s pre- eminent life sciences groups, with a global platform for innovators at every stage of the development life cycle. The firm’s collaborative approach – spanning more than 25 practice areas and touching all offices around the world – offers one of the largest and most experienced industry-specific teams, comprising more
than 300 lawyers, subject-matter experts and techni- cal advisers who deliver sophisticated transactional, regulatory, IP, and litigation and enforcement strate- gies to position industry innovators and investors for success. The Ropes & Gray team is sought after to lead clients in navigating the complex legal landscape in which the life sciences industry operates.
Contributing Editor
Lincoln Tsang heads Ropes & Gray LLP’s European life sciences practice. A former senior regulator, he received postgraduate training in toxicology and cancer pharmacology. Lincoln concentrates his practice on UK, EU
and cross-border regulatory compliance and enforcement, including litigation, internal investigations and public policy matters affecting the life sciences industry. Lincoln advises clients on R&D strategies, product life cycle management, product acquisition, and risk and crisis management. He also regularly represents clients before various regulatory bodies in a wide range of matters concerning medicines and medical devices, including clinical trials, product approval, advertising and promotion, manufacturing, safety vigilance, and health technology appraisal related to pricing and reimbursement decision-making.
Ropes & Gray LLP 60 Ludgate Hill London EC4M 7AW UK
Tel: +44 20 3201 1500 Fax: +44 0 3201 1501 Email: lincoln.tsang@ropesgray.com Web: www.ropesgray.com
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INTRODUCTION Contributed by: Lincoln Tsang, Ropes & Gray LLP
Navigating the Ever-Changing Global Regulatory Landscape: Adapting to Disruption and Uncertainty Welcome to the 2026 edition of Chambers & Part- ners’ Life Sciences Global Practice Guide. I would like to express my sincere gratitude to my colleagues for their expert contributions to this Guide. Their col- lective efforts have ensured comprehensive coverage of the latest developments across a wide range of regulatory, legal and policy issues in their respective jurisdictions. I would also like to take this opportunity to offer a few opening remarks. The global regulatory landscape for the life sciences sector is experiencing rapid and profound transforma- tion, shaped by policy innovation, regional divergence and mounting geopolitical pressures. As a result, organisations in this sector are encountering a more complex environment – one that presents both new opportunities and considerable uncertainties. Regulatory regimes around the world are evolving at an accelerated pace, with cross-border trends shaping innovation, compliance and enforcement. In 2026, we anticipate significant new developments that reflect the sector’s need to adapt to emerging scientific advances, shifting public health priorities and evolving political agendas. The interplay between regional regulatory approaches and the globalisation of life sciences innovation is intensifying the need for harmonisation, particularly in the design of clinical tri- als and the generation of evidence for rare diseases and digital health products. Leadership transitions at major regulatory agencies, especially in the United States, are influencing global priorities and creating a degree of uncertainty. Policy directions are shifting, with new initiatives focused on expedited approvals, increased transparency and alternative standards of evidence for products addressing unmet medical needs. These changes have direct implications for market access strategies, compliance expectations and enforcement risks. While the United States, European Union, United Kingdom and Asia are each pursuing distinct policy directions, there is a growing call for greater global collaboration and harmonisation. Divergent approach-
es to data exclusivity, market access and post-market surveillance are emerging, even as stakeholders seek to align on standards for innovative therapies and digi- tal health solutions. The need for harmonised regula- tory frameworks is particularly acute in areas such as rare diseases, where efficient evidence generation and timely patient access are critical. Regulators worldwide are placing greater emphasis on advertising, promotion and digital compliance, with stricter enforcement and higher expectations for organisational conduct becoming increasingly evi- dent. Developments such as enhanced transparency, real-time publication of regulatory decisions and more robust enforcement of direct-to-consumer advertising rules are reshaping the compliance landscape. In this context, life sciences companies are finding it neces- sary to adapt their approaches to enforcement risk and strengthen post-market oversight. Geopolitical tensions, trade investigations and shift- ing tariff threats are prompting a renewed emphasis on domestic production and localised supply mod- els. The United States and the European Union are prioritising domestic manufacturing, while China is advancing local supply chains to enhance resilience. These trends are influencing long-term investment planning, pricing strategies and the management of supply chain risks. Recent regional conflicts have further exacerbated these challenges, with direct consequences for the cost of goods and the stability of supply chains. Dis- ruptions to critical raw materials, increased trans- portation costs and heightened border controls have resulted in greater volatility and unpredictability in sourcing and distribution. Life sciences companies are experiencing increased costs for both inputs and finished products, as well as delays in manufactur- ing and delivery timelines. These pressures are com- pelling organisations to reassess their supply chain strategies, diversify sourcing, and invest in greater resilience to mitigate the impact of ongoing and future disruptions. Heightened geopolitical volatility is contributing to con- siderable uncertainty in global drug pricing. The risk of international price compression is rising, as countries
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INTRODUCTION Contributed by: Lincoln Tsang, Ropes & Gray LLP
adopt more assertive healthcare cost containment measures and regulatory divergence becomes more pronounced. In this environment, life sciences lead- ers and policymakers are having to reconsider their strategies to address these evolving challenges and maintain sustainable access to innovative therapies. Regionally, leadership changes at the FDA and HHS in the United States are driving policy innovation, expedited approval pathways and more aggressive enforcement, particularly in the areas of advertising and off-label promotion. There is a concerted push for more US-based clinical trials and increased transpar- ency in regulatory decision-making. In the European Union, comprehensive legislative reforms are mod- ernising pharmaceutical laws, balancing the promo- tion of innovation with improved patient access. New exclusivity frameworks, incentives for antibiotics and the proposed EU Biotech Act are reshaping the regu- latory environment. The United Kingdom’s MHRA is implementing agile approval pathways, international reliance mechanisms and modernised regulations for medical devices and digital health, positioning the UK as a competitive first-launch market. Meanwhile, China and Japan are accelerating regulatory moderni- sation, streamlining approvals for innovative therapies and adapting frameworks to support domestic priori- ties and supply chain resilience. Across all major regions, regulators are modernising and streamlining medical device regulations to foster innovation, improve patient access, and enhance reg- ulatory efficiency. There is a concerted effort to sup- port digital health, AI-driven solutions and electronic documentation, while maintaining robust safety and oversight.
Success in this dynamic and uncertain environment will depend on the ability of life sciences companies to remain agile and forward-looking. Careful monitor- ing of regulatory changes and global trends, thought- ful investment in risk management and the ongoing adaptation of compliance programmes will all play an important role. Embracing digital transformation and strengthening supply chain resilience are becoming increasingly important, particularly in light of recent disruptions. Constructive engagement with regulators and stakeholders can help shape policy and ensure organisations are well positioned for future develop- ments. In conclusion, the evolving global regulatory landscape – shaped by geopolitical tensions, regional conflicts and policy divergence – continues to present both challenges and opportunities. Successfully navigat- ing this environment calls for a considered approach, with an emphasis on agility, informed decision-making and strategic foresight. For life sciences organisa- tions, remaining responsive to change and attentive to emerging trends will be key to addressing complexity and making the most of new developments.
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AUSTRALIA
Australia
Law and Practice Contributed by: Greg Williams and Sheena McKie Clayton Utz
Sydney
Tasmania
Contents 1. Life Sciences Regulatory Framework p.10 1.1 Legislation and Regulation p.10 1.2 Challenging Decisions of Regulatory Bodies p.10 1.3 Categories of Pharmaceuticals and Medical Devices p.11 2. Clinical Trials p.11 2.1 Regulation of Clinical Trials p.11 2.2 Securing Authorisation to Undertake a Clinical Trial p.12 2.3 Public Availability of the Conduct of a Clinical Trial p.13 2.4 Use of Online Tools to Support Clinical Trials p.13 2.5 Use of Data From Clinical Trials p.13 2.6 Personal or Sensitive Data p.14 3. Marketing Authorisations p.14 3.1 Product Classification p.14 3.2 Marketing Authorisation for Biologic Medicinal Products p.14 3.3 Period of Validity of Marketing Authorisations p.14 3.4 Procedure for Obtaining a Marketing Authorisation p.15 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations p.16 3.6 Ongoing Obligations Imposed by Marketing Authorisations p.16 3.7 Third-Party Access to Pending Applications for Marketing Authorisations p.17 4. Regulatory Reliance and Fast-Track Registration Routes p.17 4.1 Fast-Track Registration Routes p.17 4.2 Regulatory Reliance p.18
5. Manufacturing of Pharmaceuticals and Medical Devices p.18 5.1 Requirement for Authorisation for Manufacturing Plants p.18 6. Distribution of Pharmaceuticals and Medical Devices p.19 6.1 Wholesale of Pharmaceuticals and Medical Devices p.19 6.2 Different Classifications Applicable to Pharmaceuticals p.19 7. Import and Export of Pharmaceuticals and Medical Devices p.19 7.1 Governing Law and Relevant Enforcement Bodies p.19 7.2 Importer of Record of Pharmaceuticals and Medical Devices p.20 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices p.20 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports p.21 7.5 Trade Blocs and Free Trade Agreements p.21 8. Pharmaceutical and Medical Device Pricing and Reimbursement p.21 8.1 Price Control for Pharmaceuticals and Medical Devices p.21 8.2 Price Levels of Pharmaceuticals or Medical Devices p.22 8.3 Reimbursement From Public Funds p.22 8.4 Cost-Benefit Analyses p.22 8.5 Regulation of Prescriptions and Dispensing by Pharmacies p.22
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AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
Clayton Utz has over 190 years of experience and has grown into one of Australia’s premier law firms, renowned for its confident approach to complex transactions and litigation. Established in 1833, it now has nearly 200 partners and over 1,600 employ- ees across six offices nationwide. As a full-service commercial law firm, it offers broad-ranging legal expertise across diverse industry sectors, working collaboratively as a national team to deliver innova- tive and incisive advice. The firm’s leading life sci- ences practice, ranked across multiple directories,
has nearly 30 years of experience in the pharma- ceutical, medical device and medtech industries. It provides practical, commercially sound advice on regulatory compliance, reimbursement, competition law, contracts, recalls and product liability. Combin- ing advanced scientific knowledge with extensive le- gal expertise, the firm helps clients navigate complex challenges efficiently, ensuring that their objectives are met with precision and care across a wide range of life sciences products.
Authors
Greg Williams is a leading and distinguished life sciences practitioner. Heralded as one of the “doyens of the class action space, in
Sheena McKie is a key figure in the life sciences practice at Clayton Utz, with lead roles in high-profile class actions and product liability litigation. She advises domestic and international clients, navigating the
particular, in the product liability space”, Greg has a track record of successful outcomes across the pharmaceutical and medical device sectors. Greg’s scientific qualifications and laboratory experience equip him with distinctive perspectives on the legal and business challenges faced by entities in the pharmaceutical and medical device fields. Beyond his successful legal practice, Greg is a respected thought leader in life sciences. His extensive contributions, through insightful papers and presentations, significantly influence the field of life sciences litigation.
intricate regulatory frameworks and legislation relevant to pharmaceuticals and medical technologies within the Australian market. Sheena also specialises in product liability, safety, recalls and compliance with the Australian Consumer Law, ensuring that clients are well prepared to address and mitigate potential legal challenges. Sheena regularly drives and contributes to thought leadership, further contributing to the industry’s understanding of critical legal issues.
Clayton Utz Level 15, 1 Bligh Street Sydney, New South Wales NSW 2000 Australia Tel: +61 2 9353 4000 Email: coobrien@claytonutz.com Web: www.claytonutz.com
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AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation The primary legislation that governs the importation, exportation, manufacture and supply of therapeutic goods in Australia – including pharmaceuticals and medical devices – is the Therapeutic Goods Act 1989 (Cth). The Therapeutic Goods Act establishes Austral- ia’s national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods, and provides the framework for the states and territories to adopt a uniform approach to the safe handling of poisons (including medicines). The Therapeutic Goods Act is supported by a number of regulations, including the following two key sets of subordinate regulations: • the Therapeutic Goods Regulations 1990, which provide detailed rules around manufacturing, sup- ply, advertising, labelling and post-market surveil- lance of medicines; and • the Therapeutic Goods (Medical Devices) Regula- tions 2002, which set out the requirements for reg- istration, classification and conformity assessment of medical devices specifically. The Therapeutic Goods Administration (TGA) is Aus- tralia’s principal regulatory authority for therapeutic goods. The TGA’s remit includes all aspects of the supply, importation, exportation, manufacturing and advertising of therapeutic goods, while also main- taining the Australian Register of Therapeutic Goods (ARTG). A therapeutic good cannot be supplied in Australia unless it is listed, registered or included on the ARTG (as applicable). The TGA is not an independent statutory authority and operates as a division of the Department of Health, Disability and Ageing, in its Health Products Regula- tion Group (HPRG). At a practical level the TGA is can be described as “semi-autonomous”, with broad day-to-day operational independence, its own organi- sational identity and its own head (who also holds the title of Deputy Secretary of the HPRG). State and territory laws govern the storage, handling, retail and wholesale of poisons, including medicines.
In addition, the National Health Act 1953 (Cth) and its delegated legislation establish the Pharmaceutical Benefits Scheme (PBS), which is Australia’s Common- wealth (federal) Government scheme to subsidise the cost of drugs and medicinal products (primarily pre- scription medicines). There is also a Prescribed List (formerly known as the Prostheses List), which sets a minimum list and associated benefit for certain medi- cal device and human tissue products that must be covered by health insurers in respect of private health insurance. 1.2 Challenging Decisions of Regulatory Bodies Three-Tiered System Australia’s therapeutic goods regime has a three- tiered system for challenging regulatory decisions, the availability of which will depend on the decision and decision-maker in question. Internal merits review by the Minister The Therapeutic Goods Act provides (in Section 60) that certain “initial decisions” made by the Secretary of the Department of Health, Disability and Ageing or their delegate may be eligible for reconsideration, which is a form of merits review. A person whose inter- ests are affected by an initial decision of the TGA may request that the Minister review the decision within 90 calendar days. The Minister may confirm or revoke the initial decision, and may make a decision in substitu- tion for the initial decision. The Minister is not limited to checking whether the original decision-maker made an error in the making of the decision. External merits review (ART) The Minister’s decision on reconsideration becomes a “reviewable decision”, and a person whose interests are affected by the decision may apply to the Austral- ian Review Tribunal (ART) (which replaced the AAT on 14 October 2024) for review of that decision. The ART considers all evidence before it and seeks to make the “correct or preferable decision”. An application to the ART must be filed within 28 days of being notified of the Minister’s decision (and reasons for that decision). Judicial review (Federal Court) A person aggrieved by certain administrative deci- sions made by a public authority may seek judicial
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AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
review under the Administrative Decisions (Judicial Review) Act 1977 (the “ADJR Act”) or under Section 39B of the Judiciary Act 1903. Judicial review is differ- ent to merits review, and is an examination of whether decision was made lawfully – that is, whether the pro- cess by which the decision was made was lawful, fair and reasonable, rather than whether the correct deci- sion was in fact made. Judicial review procedures (in contrast to the mer- its review procedures) may be available in respect of government decision-making by any level of govern- ment, unless the decisions are expressly excluded from such review. Judicial review is often considered in respect of Ministerial decisions relating to the Phar- maceutical Benefits Scheme, or steps preparatory to the making of such decisions (eg, recommendations by the Pharmaceutical Benefits Advisory Committee). Food products are regulated by reference to the Food Standards Code, which are given legal status by appli- cation laws in each state and territory. The state Food Authorities are the regulatory bodies for those stand- ards. 1.3 Categories of Pharmaceuticals and Medical Devices Australia uses a risk-based tiered system for regulat- ing therapeutic goods. The level of risk associated with a particular category of product will dictate the application pathway for inclusion on the ARTG, as well as what evidence is required to be held or provided to the TGA to achieve a listing. The higher the classifica- tion, the more rigorous the pre-market assessment will be. Low-risk medicines (most vitamins and supplements) are simply listed on the ARTG based on sponsor self- certification, while higher-risk medicines (prescription drugs, over-the-counter (OTC) medicines) may only be registered after a full TGA evaluation of safety, quality and efficacy. In addition, substances (including in cer- tain forms or concentrations) may be “scheduled” by being included on the Poisons Standard. The Poisons Standard is a legislative instrument that classifies sub- stances (again by risk) into “Schedules”, including Schedule 2 (Pharmacy Only), Schedule 3 (Pharmacist Only), Schedule 4 (Prescription Only) and Schedule
8 (Controlled Substances). Scheduling also impacts storage and handling requirements (governed by state and territory legislation). Unscheduled (or General Sale) Medicines Unscheduled medicines have been determined to be suitable for supply without supervision by a qualified healthcare professional and are available for general sale (such as in supermarkets). Sometimes, these medicines will be a smaller pack size or lower dos- age than other scheduled medicines. Medical devices are subject to a separate classifica- tion framework with risk tiers ranging from Class I (low-risk items such as bandages, largely self-certi- fied) through to Class III (high-risk items such as heart valves or other implantable devices, requiring more detailed assessment by the TGA). A parallel four-class system assesses in vitro diagnostic devices. Clinical trials of unapproved therapeutic goods in Aus- tralia are regulated by the TGA under the Therapeutic Goods Act 1989 (Cth) and associated regulations, including the Therapeutic Goods Regulations 1990 (Cth) and the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth). More specifically, unapproved therapeutic goods (including pharmaceuticals and medical devices) are exempt from the requirement to be listed, registered or included on the ARTG where those goods are being supplied for use in a clinical trial solely for experimen- tal purposes in humans and where such supply is subject to oversight by the TGA via either the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) pathway. Unapproved goods also include therapeutic goods which are included in the ARTG but which will be used in a manner not covered by the existing ARTG entry during the clinical trial. 2. Clinical Trials 2.1 Regulation of Clinical Trials The regulatory framework applies to medicines, bio- logicals and medical devices, and is supported by ethical and governance requirements at the institu- tional level. Clinical trials must comply with:
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• the National Statement on Ethical Conduct in Human Research (the “National Statement”) issued by the National Health and Medical Research Council; • relevant Good Clinical Practice (GCP) guidelines, including the International Council for Harmonisa- tion (ICH) GCP Guideline for medicines and bio- logicals; and • principles based on the Declaration of Helsinki. Clinical trials must be conducted in accordance with a Protocol approved by a Human Research Ethics Committee (HREC), which will also be responsible for monitoring the conduct of the trial at each study site. A clinical sponsor, which must be an Australian entity, will take on the obligations of running the trial, includ- ing making any notification or application to the TGA under the CTN and CTA pathways. Clinical trials that do not involve the use or supply of unapproved prod- ucts do not need to follow the CTN or CTA pathways but will still require HREC supervision. State and territory laws, and institution-based rules, should also be taken into account. Importantly, together with the industry body for innovative medi- cines, Medicines Australia, the National Clinical Trial Agreement (NaCTA) Panel (comprised of representa- tives from all states and territories) has developed five Clinical Trial Research Agreements that are available for use by any sponsor and/or institution for specific types of clinical trials. Certain institutions (eg, public hospitals) conducting clinical trials will insist on using these Agreements without amendment. 2.2 Securing Authorisation to Undertake a Clinical Trial The clinical trial sponsor must determine whether a clinical trial will proceed under the CTN or CTA path- way, based on the risk profile of the investigational product. The choice of pathway must also be con- firmed by the HREC. The main difference between the pathways is the level of TGA review before the clinical trial commences. The CTA pathway is typically used for higher-risk or novel treatments such as gene therapy, where there is no or limited knowledge of safety associated with the product. The CTN pathway can be used for all other
studies, but will usually be appropriate where there is already some pre-clinical data supporting the safety of the device in humans. Studies involving Class 4 bio- logicals must use the CTA pathway unless evidence from previous clinical use supports the use of the bio- logical or a national regulatory body with comparable regulatory requirements has approved a clinical trial for an equivalent indication. The TGA has recently been undertaking a review of the CTA pathway, including in relation to the focus for review of the TGA compared to the HREC. This review is ongoing. CTN Pathway The CTN scheme is a notification scheme. The TGA does not review or evaluate any data relating to the clinical trial. Under the CTN pathway: • the clinical trial sponsor obtains HREC approval and site governance authorisations; • the clinical trial sponsor submits an online notifica- tion to the TGA and pays the applicable fee; • any variations to the information submitted as part of the CTN form during the clinical trial must also be notified to the TGA; and • the clinical trial sponsor should submit further notification to the TGA once the clinical trial activity relating to the supply of unapproved therapeutic goods is complete. CTA Pathway The CTA scheme is an approval scheme. The TGA will review manufacturing, safety and quality data, includ- ing any relevant pre-clinical or early clinical data that may be available, even if limited, to conduct a risk- benefit analysis that will inform their decision about whether to approve the trial. Under the CTA pathway: • the clinical trial sponsor submits an application to the TGA for evaluation and approval of the inves- tigational product’s use in the trial, and pays the applicable fee;
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• once TGA approval is granted, the clinical trial sponsor must still obtain HREC approval (which will focus on scientific and ethical issues relating to the clinical trial protocol) and site governance authorisations before commencing the trial; • any significant changes to the manufacturing and quality and safety data reviewed and approved by the TGA, or any other aspect of the trial provided to the TGA with the CTA application, must be given to the TGA and may also require TGA approval; and • clinical trial sponsors should also notify the TGA of clinical trial completion after the trial has been completed at all study sites. 2.3 Public Availability of the Conduct of a Clinical Trial While the legislation does not expressly require the registration of clinical trials in Australia, the National Statement mandates that researchers must regis- ter any research project that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes on a publicly accessible registry before participant recruitment begins. When registered, certain information about each clini- cal trial, including results after trial completion, will be made available to the public. Clinical trial registries include the Australian New Zealand Clinical Trials Reg- istry (ANZCTR), the US ClinicalTrials.gov or the World Health Organization (WHO) International Clinical Trials Registry Platform. 2.4 Use of Online Tools to Support Clinical Trials The use of digital technology – including online recruit- ment, e-consent, electronic patient-reported out- comes (ePROs), telehealth and remote monitoring – is generally permitted in clinical trials in Australia. Many clinical trial sponsors utilise these tools to recruit participants, conduct virtual trials, manage data and monitor outcomes. In using these tools, clinical trial sponsors must comply with: • good clinical practice principles;
• the Privacy Act 1988 (Cth) (including the Australian Privacy Principles (APPs) set out therein) and any relevant state/territory health privacy legislation; • the National Statement; • HREC approvals; and • site governance requirements. Given that health information is classified as sensitive information, it is subject to higher protections. All recruitment materials and processes, including online materials, require approval from the relevant HREC. Sponsors must provide clear collection notices and obtain express consent where necessary. Clinical trial sponsors must also ensure that they implement proportionate security measures to protect data and ensure that any third-party service providers comply with Australian privacy legislation. Contracts with service providers should address key aspects such as data processing, security and audit rights. 2.5 Use of Data From Clinical Trials Clinical trial datasets commonly contain personal information and often sensitive information (including health and genetic information). As a result, handling and sharing of trial data must align with the Privacy Act 1988 (Cth) (including the Australian Privacy Prin- ciples found in the Privacy Act), and any applicable state and territory health privacy legislation. For Australian law purposes, personal information is any information or an opinion about an identified indi- vidual or an individual who is reasonably identifiable . The question of whether an individual is reasonably identifiable from the information or opinion in question depends on context and the circumstances in which the information is held. For this reason, anonymised or pseudonymised trial data might still be considered personal information and therefore subject to the requirements of Australia’s privacy laws. Use and disclosure should be limited to the research purposes for which the data was collected unless a rel- evant exception applies or fresh consent is obtained. Research-specific allowances may be available under approved guidelines where consent is impracticable
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and public interest tests are met, subject to HREC approval. Disclosures to CROs, service providers and affiliates must be documented and controlled. Cross-border disclosures require reasonable steps to ensure that overseas recipients protect personal information con- sistently with the APPs and engage accountability for offshore disclosures. Appropriate contractual, techni- cal and organisational measures should be in place, and de-identified datasets should be used where fea- sible. 2.6 Personal or Sensitive Data Creating a database that contains personal or sen- sitive information will be required to meet minimum requirements set out in the Privacy Act. Patient con- sent forms supporting the creation and use of such a database will be important to what additional require- ments will be needed. The Australian Privacy Princi- ples impose a range of obligations, including to: • maintain a clear, up-to-date privacy policy and pri- vacy management plan, assign accountability, and embed privacy by design; • collect only what is reasonably necessary for the research and related operational purposes; • implement proportionate technical and organisa- tional security controls, vendor due diligence and access management; and • establish retention schedules and destroy or de-identify personal information when no longer required.
The following key points are relevant for the assess- ment process: • classification is the responsibility of the medicine or device manufacturer – however, the sponsor will be required to make the application and to make certain certifications to the TGA; • the TGA provides online decision tools to guide sponsors through the process, and sponsors can also consult the TGA directly for novel or ambigu- ous products; and • for medical devices, the manufacturer assigns the intended purpose for a device and will also deter- mine the risk class (Class I–III, or Class 1–4 for in vitro diagnostic devices), having regard to whether the device is powered and the body system involved. Often, products do not neatly correspond to one cate- gory, and will depend on therapeutic claims made and the scientific evidence for the how the product works. Boundary or combination products will be classified according to their principal therapeutic effect. A num- ber of legislative instruments also declare or deter- mine certain products to be therapeutic goods, or to be excluded from the application of the therapeutic goods regime. 3.2 Marketing Authorisation for Biologic Medicinal Products In Australia, biological medicines (eg, monoclonal antibodies, vaccines, gene therapies) follow the same registration pathway as other prescription medicines on the ARTG. There is no separate biologics licence in Australia. At a practical level, manufacturing and quality (CMC) data for biologicals may face height- ened scrutiny as biologicals are produced from living systems and are generally more variable than conven- tional chemical drugs. 3.3 Period of Validity of Marketing Authorisations In Australia, ARTG entries for medicines and medi- cal devices do not expire, and an entry remains valid indefinitely, provided the sponsor continues to meet its ongoing obligations (namely, payment of annual charges where applicable) and the product is not otherwise cancelled or suspended from the ARTG.
3. Marketing Authorisations 3.1 Product Classification
Classification in Australia turns on the principal intended action of the product. If a product works by pharmacological, immunological or metabolic means, it is a medicine; if it works by physical means, it is a medical device. Biologicals (products derived from human cells/tissues) are classified by what they are made from, not how they work.
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Provisional registration for certain therapeutics will expire after two years (extendable up to six years), if the sponsor has not submitted confirmatory clinical data during that period. The TGA: • can suspend marketing authorisation/ARTG registration on grounds including safety or quality concerns, non-compliance with conditions, failure to pay annual charges, or the provision of false or misleading information; • can suspend authorisation as an interim measure while concerns are investigated; and • cannot suspend marketing authorisation due to “failure to market”, unlike in the EU – however, the TGA discourages sponsors from leaving their products on the ARTG where they have determined that no further supplies of the product will occur in Australia. 3.4 Procedure for Obtaining a Marketing Authorisation To obtain a marketing authorisation for a registered medicine , a sponsor must submit an application via the TGA Business Services (TBS) portal, supported by a dossier in Common Technical Document (CTD) format. The TGA evaluates the medicine within maxi- mum statutory timeframes, being up to 255 working days, reduced to 175 working days where the medi- cine is already approved by a comparable overseas regulator, and further reduced to 120 working days where manufacturing is acceptable and only labelling/ product information and risk management remain out- standing. The legislation also permits certain “clock stop” periods where the TGA has made a request for information. Once a medicine is registered on the ARTG, no change to the medicine as approved by the TGA can be made without TGA notification or approval – depending on the variation in question. Those changes that will require evaluation of clinical or bioequivalence data will be more significant. Most changes to a sponsor will simply require notification to the TGA. Listed medicines are not individually evaluated by the TGA for quality, safety or efficacy before they can be
supplied in the marketplace. A sponsor must certify that the listed medicine meets applicable require- ments and that all ingredients are found on the Thera- peutic Goods (Permissible Ingredients) Determination (No 1) 2026 (Cth). A new listing or registration on the ARTG (and therefore a new application) must be sought for any medicine that is “separate and distinct” from other therapeutic goods (including any current listings/registrations). This includes where the formulation or composition of the goods is different, the medicines have different dosage forms and strengths, and the product has a different name. For medical devices, sponsors must demonstrate compliance with the Essential Principles and apply appropriate conformity assessment procedures. Inde- pendent certification of the manufacturer’s conformity assessment procedures is required for all classifica- tions except for Class I non-sterile, non-measuring devices and Class 1 IVD devices (which can be self- certified by the manufacturer providing a Declaration of Conformity). Where devices are manufactured out- side Australia, sponsors may be able to rely on cer- tification from EU Notified Bodies or approvals from comparable overseas regulators (US FDA, Health Canada, Japan PMDA, Singapore HSA), as set out in the Therapeutic Goods (Medical Devices – Informa- tion that Must Accompany Application for Inclusion) Determination 2018 (Cth). Where TGA conformity assessment certification is required for a new application, this process must be completed within a statutory timeframe of up to 255 working days. Otherwise, applications for ARTG inclu- sion must be approved or selected for audit within a statutory timeframe of 20 business days. As with medicine applications, the legislation also permits cer- tain “clock stop” periods where the TGA has made a request for information. For medical devices , a single ARTG entry may cover more than one device (and instead covers a “kind of medical device”), provided that they have the same sponsor, manufacturer, device nomenclature system code, medical device classification and, for certain higher risk products (Class 4 IVDs, Class III devices
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AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
Personal Importation Individuals may import a limited supply of an unap- proved medicine for their own personal use, subject to conditions. Compassionate use programmes typically apply to medicines (or devices) after they have received mar- ket authorisation (registered on the ARTG) but before (or separate from) reimbursement on the PBS. It is an offence to advertise unapproved therapeutic goods to the public. 3.6 Ongoing Obligations Imposed by Marketing Authorisations The Therapeutic Goods Act 1989 (Cth), Therapeu- tic Goods Regulations 1990 (Cth) and Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) impose standard conditions on the person in rela- tion to whom a medicine is registered or listed, or in relation to whom a medical device is included, on the ARTG. These include obligations relating to post- marketing surveillance, including pharmacovigilance and technovigilance, as well reporting requirements. Pharmacovigilance (Medicines) It is a condition on registration or listing that the person in relation to whom a medicine is registered or listed on the ARTG must comply with the record-keeping and reporting requirements set out in the document pub- lished by the TGA titled Pharmacovigilance Respon- sibilities of Medicine Sponsors (as in force from time to time, and given force by the Therapeutic Goods Regulations). Sponsors must report adverse events to the TGA in accordance with those requirements, including reporting serious/unexpected events within 15 calendar days and significant safety issues within 72 hours. Sponsors must also maintain updated risk management plans and adhere to any TGA-imposed post-market conditions (especially if provisionally reg- istered). Technovigilance (Medical Devices) It is a condition on inclusion that the person in relation to whom a device is included on the ARTG must give certain information to sponsors and must comply with the record-keeping and reporting requirements set out in the Therapeutic Goods (Medical Devices) Regula- tions. Sponsors must report adverse events involving
and IVD companion diagnostics), the same unique product identifier. Transfer of a sponsorship for a medicine or medical device is permitted. The legislation provides that the change of sponsor occurs automatically upon the happening of certain events – however, in practice, the process requires: • notification to the TGA of the change in sponsor; • updating the ARTG to reflect the new sponsor’s details; and • the new sponsor applying for a variation to update the product information and labelling with the new sponsor details. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations There are four main pathways for accessing therapeu- tic goods that do not have applicable market authori- sation (ie, that are not on the ARTG) in Australia. Special Access Scheme This allows registered health practitioners to access unapproved medicines, devices or biologicals for indi- vidual patients on a case-by-case basis. There are three subcategories: • immediate access for seriously ill patients (cat- egory A); • TGA pre-approval (category B); and • immediate access for products with an established history of use (category C). Authorised Prescriber Scheme This allows medical practitioners to prescribe a speci- fied unapproved good to a class of patients with the same condition, without needing individual approv- als, subject to Human Research Ethics Committee approval or specialist college endorsement. Clinical Trials These allow unapproved goods to be supplied to patients enrolled in an approved clinical trial conduct- ed under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) scheme, provided that specified requirements for the supervision and conduct of the clinical trial can be met.
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AUSTRALIA Law and Practice Contributed by: Greg Williams and Sheena McKie, Clayton Utz
their devices to the TGA, including events that led or might have led to death, serious injury or serious deterioration in health. Sponsors must also maintain a post-market surveillance system including systematic review of post-market experience. Common Obligations (Medicines and Medical Devices) Sponsors must ensure continued compliance with Good Manufacturing Practice and conformity assess- ment requirements throughout the product life cycle, pay annual ARTG charges, and ensure that product information, labelling and advertisements are kept up to date and in line with TGA requirements. For both medicines and medical devices, a sponsor must fol- low the TGA’s procedure for recalls, product alerts and product corrections (PRAC) and – except where immediate action is required – must engage with the TGA and receive its approval before taking in-field action in relation to a recall. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations The TGA publishes on its website a database of appli- cations for new medicines or new uses for existing medicines that are currently under evaluation by the TGA. The following will be published on this database: • information about applications for a “new medi- cine” containing a new active substance (new chemical entity or new biological entity) not cur- rently approved in Australia; • applications for a “new combination” where two or more already approved medicines are combined into a single product; and • applications for a “new indication” or additional therapeutic use for an already approved medicine. Using this “Prescription Medicine Applications Under Evaluation” database, third parties can review the pro- posed product trade name, active ingredient(s), the applicant (who will become the sponsor), a summary of the proposed indication and the application type. The database is updated monthly. Once the TGA has made its decision in relation to an application, the following applies.
• If approved and included in the ARTG, a third party can access the product name, sponsor, active ingredients, ARTG number, and conditions of regis- tration (if any, in addition to the standard conditions imposed by statute) via the publicly accessible ARTG. • For approved prescription medicines, an Australian Public Assessment Report (AusPAR) that summa- rises the clinical, non-clinical and quality evalua- tion, including the basis for the decision, may be published on the TGA’s website. The TGA’s guid- ance is that AusPARs will typically be published for products containing new chemical and biological entities, biosimilar medicines, major variations and extensions of indications where the TGA deci- sion-maker received independent expert advice, or where the information is considered to be in the interest of the Australian public. An AusPAR may still be published even if an application was rejected. • The TGA also publishes prescription medicine decision summaries (AusPMDSs), providing a brief overview the TGA’s assessment and decision to approve or not approve a new prescription medi- cine. Information about applications for medical devices is not published. Section 61 of the Therapeutic Goods Act prohibits TGA officials from disclosing “protected information”, which broadly includes any information obtained under the Act that is not publicly available, except in specified circumstances (eg, to protect public health, for law enforcement, or with the sponsor’s consent). Furthermore, Australian privacy legislation would ordi- narily prohibit the publication of information relating to individuals (especially health or other sensitive infor- mation), unless they have expressly given consent. 4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes The TGA offers several accelerated pathways for therapeutic goods.
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