Regulation of Human Medicine

The purpose of this page is to give an overview of the regulatory landscape for human medicines in Australia and other countries with which Australia closely aligns its regulatory approach. It is not intended as legal advice and is intended solely to provide guidance materials to aid the human medicine industry to replace or reduce the use of animals in the regulatory setting. For specific regulatory questions, please contact the regulator in your country of operation.  Please note that this is a rapidly evolving field and this page compiles information relevant at the point of publication. 

The following are New Approach Methods, technologies, or guidance’s that can help reduce or replace animal use and have been considered at the regulatory level:

EMA

1. Methods available on the TSAR – Tracking System for Alternative methods towards Regulatory acceptance
2. Computational methods such as Quantitative Structure Activity Relationship, Grouping and read-across and Physiologically Based Pharmacokinetics (PBK). The Virtual second species is an example of the use of PBPK modelling that can reduce the use of animals in testing.
3. PBPK guidance for industry has been developed by the EMA.
4. The EMA Provides Opinions and letters of support on the qualification of novel methodologies for medicine development

US FDA

• The USA FDA uses the TSAR – Tracking System for Alternative methods towards Regulatory acceptance 
• Other computational methods and approaches are evaluated here 
• PBPK guidance has been reported by the FDA: 
• Computer modelling and simulation guidance has been provided for industry

The FDA has issued draft guidance to inform individuals and organizations interested in qualifying a Drug Development Tool (DDT) about the qualification process as outlined in the 21st Century Cures Act. For more information on FDA’s current thinking on the DDT qualification process please see here. Guidelines for the qualification process are here. 

Other methods/strategies that are commonly used which reduce animal studies:

• Preclinical systematic reviews 
• Integrated approaches to Testing and Assessment 
• Adverse Outcome Pathways approach 

Background key points: 

• The Therapeutic Goods Administration (TGA) is the regulator in Australia.
• The TGA is part of the Health Products Regulation Group (HPRG), which comprises the TGA and the Office of Drug Control. 
• Australia aligns primarily its regulatory approach with the European Union (EU), the International Committee on Harmonization (ICH), and the United States Food and Drug Administration (US FDA) through the adoption of its international guidelines.  
• The TGA has mutual recognition agreements with Europe, the United Kingdom, Canada, New Zealand, and Singapore.
• Australia has a cooperative agreement with the US FDA 
• The TGA is an observer of the ICH. 
• The TGA is legislated primarily through the Therapeutic Goods Act (1989), Therapeutic Goods Regulations (1990), and through Therapeutic Goods Orders, via the Therapeutic Goods Act 1989 (Chapter 3, Part 3-1, 10 Determination of Standards, (1)).
• International scientific guidelines are adopted by the TGA
• Australia is in the International Medicines Regulators’ Working Group on 3Rs. The terms of reference for this group can be found here. 
• The TGA is designated as a WHO Listed Authority. 

Legislation in Australia surrounding the use of animals in regulatory settings:

Whilst the TGA Act (1989) does not mandate animal testing, animal test data may be a condition of approval as implied by guidelines falling under this Act. Whilst most guidelines are subordinate to the Act, the M4 (safety) guidance sets a legislative requirement for mandatory requirements for an effective application.

This means applicants must “include such information as will allow the determination (preliminary assessment) of the application” and;

“Applications referred to in regulation 16C of the Regulations (including, Category 1 and Comparable Overseas Regulator (COR) report-based applications for new registrations, other than applications for an additional trade name) must comply with the following regulatory documents”

The M4 (safety) guideline states that “If alternatives to whole-animal experiments are employed, their scientific validity should be discussed.” This implies that whole animals should be used, and scientifically valid alternatives will be considered.

Guidelines that discuss scientific validity of alternative approaches that have been accepted by the TGA include:

PBPK guidelines

Guidelines

Guidelines (other than the M4) are not legislated but they are strongly encouraged to be followed. 

Guidelines may explicitly state that alternatives can be considered, for example:

ICH guideline S6 (R1) – preclinical safety evaluation of
biotechnology-derived pharmaceutica

In the above guideline, section 4.1 (Safety Pharmacology), it states that “investigations may also include the use of isolated organs or other test systems not involving intact animals.”

Australia and the Australian Therapeutic Goods Administration have the following facilities and strategies which can decrease the use of animals and support the use of alternatives to animal use:

1. The ability to adopt international guidelines.
   – International guidelines which the TGA have adopted can be found generally here though the search function: 
   – Guidelines which the TGA could adopt to reduce or replace the use of animals in alignment with the EMA review are here (please note some may already be adopted).  Additionally, some are recommended through the European Federation of Pharmaceutical Industries and Associations in their webinar.
2. The publication of AusPars through the transparency agreement in the Therapeutic Goods Act (1989). An AusPar is an overview of the drug sponsors application which can provide insight into which non-animal models were used, or which animal tests were not justified.
3. AusPar falls under the TGA Act (1989), Volume 2, Chapter 7, section 61, 5A section 61 “release of information”. The Secretary may release to the public therapeutic goods information relating to any decision or action taken under this Act or the regulations.”
4. A regulatory science strategy published by the Health Products Regulation Group (HPRG): 
   a. The strategy focused on four key areas:
   i. Maintain and build skills in regulatory science
   ii. Improve domestic and international collaboration with other government agencies, scientific organisations and regulators
   iii. Increase responsiveness to emerging technologies
   iv. Improve communication and engagement with stakeholders about regulatory science.
5. A non-animal models strategy published by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) making the following recommendations: 1) Establish a national consortium that coordinates and promotes Australia’s non-animal model capabilities, 2) Develop national data collection standards on the use of animals in scientific research, teaching, and testing, 3) Align TGA processes and industry guidance with new FDA procedures for accepting non-animal model data, 4) Develop a national biobanking and tissue collection network, 5) Integrate outputs from NCRIS platforms into a coordinated pipeline for non-animal models, 6) Facilitate IP (intellectual property) management and material access for research and industry collaborations, 7) Enhance commercial skillsets across the non-animal model sector, 8) Update biomedical R&D infrastructure to support non-animal model capabilities, 9) Conduct retrospective studies that compare animal and non-animal model predictivity, 10) Conduct systematic reviews of locally and internationally developed non-animal models.

A TGA representative presented the TGA’s approach to NAMS at a NIH and FDA Workshop on Reducing Animal Testing. View at 4 hours 25 mins. 

A paper was released in May 2026 outlining Australia’s competitive advantage in advancing NAMs to clinical trial. 

The Australian Government Department of Health and Aged Care also published a Scoping Report Towards alternatives to animal testing of industrial chemicals in Australia which has some crossover with medical products. 

In addition to implementing the recommendations and key points of the CSIRO non-animal strategy and the MHRA regulatory strategy, Australia could:

• Establish the equivalent of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICVAAM) or European Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) and relevant scientific advisory committees
• Become an observer or member of the international cooperation on alternative test methods (ICATM)
• Create the equivalent of the innovation task force (EU) or the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program (US)
• Enact supportive legislation where necessary
• Adopt supportive guidelines both to reduce the number of animals used and to increase the uptake of alternative methods with guidances for credibility or validity of method

• • The FDA approved an Investigational New Drug (IND) application using efficacy data solely from Qureator’s human vascularized organoid model, moving an oncology drug to human clinical trials without any animal tests for the first time.
  • In January 2019, the regulator approved in-human clinical trials for a cancer therapy developed by Achilles Therapeutics whose application had not been supported by animal data.  The therapy involved using a patients’ own immune cells to treat the cancer, rendering animal data particularly irrelevant
  • French pharmaceutical group Sanofi receive approval from the US Food and Drug Administration for a clinical trial to extend approval of an existing drug to a new disease, a rare autoimmune condition, chronic inflammatory demyelinating polyneuropathy, or CIDP, on the basis of organ chip data alone.
  • Israelis create cancer drug without animal tests, by using human-simulating chip | The Times of Israel
  • Dynamical model of glucose-insulin system (artificial pancreas) for preclinical testing of closed-loop control strategies (Kovatchev et al 2008). Accepted and approved by the US Food and Drug Administraton FDA.
  • CN Bio PhysioMimix Organ-on-a-Chip data supports Inipharm’s INI-822 for metabolic liver disease treatment now in clinical testing.
  • The FDA granted a ‘label extension’ for one of the CFTR modifiers, based purely on data from human cell models. 
  • Read case studies of new drug and biologic approvals by the FDA aided by PBBK.
  • The US EPA has accepted NAMS in lieu of the 90-day rat inhalation toxicity test
  • A whitepaper by Scendia includes examples of drugs tested by NAMs including ZIMHI and Ubrogepant
  • Insilico Medicine launched its first trial in humans of its computer-designed drug candidate after demonstrating its artificial intelligence platforms could not only identify a potentially new cellular target for the treatment of idiopathic pulmonary fibrosis but also conjure up a novel drug in less than 18 months (chronic lung disease).
  • Incorporation of stochastic engineering models as prior information in Bayesian medical device trials
  • A Nature Reviews Drug Discovery article provides cases studies from recent projects in which animal models alone provided to be limited for safety testing, and highlights four categories of drug candidates for which in vitro safety solutions are feasible
  • A gene therapy to treat CLN2 (Battens Disease) has been approved for clinical trials with efficacy and dosing data based purely on in vitro technology. Clinical trial (NCT05791864) is currently ongoing in Germany and UK.
  • TGA (Australia) supplied examples are provided below:
  • Variations for an existing medicine. This is more often than not related to a proposed new use (clinical indication), route of administration or impurity profile that is highly dependent on clinical (human) or quality (chemistry) data and where the provision of animal data are not required. Brexipiprazole AusPAR: https://www.tga.gov.au/sites/default/files/auspar-brexpiprazole-210304.pdf
  • Literature-based submissions. These applications are often related to a history of use in humans and where there is sufficient data on the safety and efficacy of the medicine in the scientific and clinical literature, where specific animal-based data are not required. Artemether AusPAR: https://www.tga.gov.au/sites/default/files/auspar-artemether-191204.pdf
  • Comparable overseas regulatory evaluations. The TGA has a number of bilateral and multilateral relationships with other national or overseas, pharmaceutical regulators and entities. While this arrangement was not established primarily to reduce the quantity of nonclinical animal-based studies, it has the effect of reducing of the number of requests for additional studies if a suitable assessment report is already available. Sacituzumab AusPAR: https://www.tga.gov.au/sites/default/files/auspar-sacituzumab-govitecan-220329.pdf
  • Guidance on using evaluation reports from Comparable Overseas Bodies. https://www.tga.gov.au/sites/default/files/2022-11/guidance-using-evaluation-reports-comparable-overseas-bodies.pdf This guidance is specifically for use with evaluations of registered complementary medicines, assessed listed medicines and substances for use in listed medicines.
  • Non animal-based studies within the nonclinical data set. Within a number of applications, some of the nonclinical studies have used in silico (structure-activity or alerts) and in vitro (bacterial, animal and human cells) methods. These methods have been used for mutagenicity (in silico, bacterial cells), genotoxicity (animal cells), primary pharmacology (animal and human cells), drug or chemical interactions (in silico, animal and human cells), skin & eye irritation (animal cells) and initial metabolic studies (animal and human cells). Lemborexant AusPAR: https://www.tga.gov.au/sites/default/files/auspar-lemborexant-220328.pdf (primary pharmacology and pharmacokinetic drug interaction
  • ICH guidance indicating that nonclinical studies are not required. This may occur for example with biotechnology-derived pharmaceuticals were some of the usual animal-based studies are not applicable. Luspatercept AusPAR: https://www.tga.gov.au/sites/default/files/auspar-luspatercept-220427.pdf (genotoxicity and carcinogenicity studies were not conducted).

Background Key Points 

• 1965: First EU-wide medicines legislation adopted, replaced by the EU Medicines Directive (Directive 2001/83/EC) in 2001
• The European Medicines Agency (EMA) is an agency of the European Union (EU) and is the main regulator in Europe. Created in 1995, it was established to centralise the authorisation of medical products across the EU. 
• The EMA has issued advice on: Regulatory acceptance of new approach methodologies: how to interact with EMA
• The European Commission is the executive of the European Union and the European Commission is a founding regulatory member of the International Committee for Harmonization

• In 1986 the European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes (ETS No. 123) was open for signature. This Convention is designed to reduce both the number of experiments and the number of animals used for such purposes This Council of Europe Convention paved the way for the EU’s Directive 86/609/EEC, adopted in 1986, as the provisions in it are based on the Convention. In September 2010, the EU adopted a new Directive 2010/63/EU on the same subject replacing Directive 86/609/EEC, which came into effect in 2013.

EU pharmaceutical legislation comprises directives, regulations, and non-legislative acts.

• The legislation is supported by guidelines
• The European Commission has established the European Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM). EURL ECVAM is an integral part of the Joint Research Centre (JRC), the science and knowledge service of the European Commission.
• EURL ECVAM has established the Scientific Advisory Committee (ESAC)
• ECVAM has launched a series of studies to review available and emerging non-animal models being used for research in seven disease areas
• EURL ECVAM is part of the International Cooperation on Alternative Test Methods (ICATM)

The European Union and the European Medicines Agency have taken the following actions which can reduce the use of animals and support the use of alternatives to animal use:

1. Published an EU regulatory strategy to 2025.
2. Conducted a review of all international guidelines so that EMA documents should not make reference to animal testing that is no longer considered appropriate.
3. Enacted a supportive legislation motion
4. Enacted Directive 2010/63. Particularly: “(10) While it is desirable to replace the use of live animals in procedures by other methods not entailing the use of live animals, the use of live animals continues to be necessary to protect human and animal health and the environment. However, this Directive represents an important step towards achieving the final goal of full replacement of procedures on live animals for scientific and educational purposes as soon as it is scientifically possible to do so. To that end, it seeks to facilitate and promote the advancement of alternative approaches. It also seeks to ensure a high level of protection for animals that still need to be used in procedures. This Directive should be reviewed regularly in light of evolving science and animal-protection measures”
5. Established an Innovation Task Force in 2014
6. Established a Tracking System for Alternative methods towards Regulatory acceptance
7. Provision of guidelines for regulatory acceptance of 3Rs testing approaches: and concept paper in development
8. Published a draft reflections paper on regulatory testing and the 3Rs which an overview of all the EU regulatory requirements for animal testing and non-animal alternatives/3Rs approaches that are accepted/utilised or proposed/being investigated
9. In 2010 established an Expert Group on the 3Rs (JEG3Rs)
10. In 2017: established the 3Rs Working Party 
11. Released European Commission “Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments” (Response to CFI European Citizens Initiative, “Save Cruelty-Free Cosmetics”)
12. Established The International Medicines Regulators’ Working Group on 3Rs (IMRWG3R) (International Tactical goal of 3RsWP)

Examples of 3Rs achievements (including some veterinary medicines) can be read here. 

Background Key Points 

• The United States Food and Drug Administration (FDA) is the regulator in the United States
• The FDA is a founding regulatory member of the International Council on Harmonization (ICH)  
• US pharmaceutical legislation includes the FDA Re-authorization Act (2017) and the 21st Century Cures Act (2021).
• The Interagency Coordinating Committee on the Validation of Alternative Methods (ICVAAM) was set up with the ICVAAM Authorization Act 2000, whose aim is: “To establish, wherever feasible, guidelines, recommendations, and regulations that promote the regulatory acceptance of new or revised scientifically valid toxicological tests that protect human and animal health and the environment while reducing, refining, or replacing animal tests and ensuring human safety and product effectiveness”
• ICVAAM is supported by the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)
• ICVAAM has established a Scientific Advisory Committee (SACTM)
• ICVAAM has established working groups
• The FDA is a member agency of ICVAAM
• ICVAAM is part of the International Cooperation on Alternative Test Methods (ICATM)

The United States and the United States Food and Drug Administration have taken the following actions which can decrease the use of animals and support the use of alternatives to animal use:

• • Published a Roadmap to Reducing Animal Testing in Preclinical Safety Studies 
  • Published A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States  
  • Through this process, a registry of alternative methods that have been accepted is available.
  • The FDA Center for Drug Evaluation and Research (CDER) released a new table to support the use of NAMs reduction of animal use. The table contains an inventory of drug development contexts for which CDER is open to a streamlined nonclinical program.
  • Established the “Innovative Science and Technology Approaches for New Drugs (ISTAND)” program for the inclusion of new approach methods and digital technologies in sponsor applications.
  • Through ISTAND the drug development tool search is available for successful applications;  
  • Enacted supportive legislation through the FDA Modernization Act 2.0. In Section 3209 (Animal Testing Alternatives) of the Consolidated Appropriations Act 2023, the FDA Modernization Act 2.0 amends Section 505 of the Federal Food, Drug, and Cosmetic Act, which mandates animal toxicity testing of novel drugs prior to their deployment in human subjects in the course of clinical trials. Specifically, changes include, 1) substituting the term “nonclinical tests” for the current “preclinical tests” (including tests on animals), 2) substituting the term “animal” for “nonclinical tests” and, 3) adding a new section defining “nonclinical tests” where “the term ‘nonclinical test’ means a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test, that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug. Such tests may include the following:(1) Cell-based assays.(2) Organ chips and microphysiological systems.(3) Computer modeling.(4) Other nonhuman or human biology-based test methods, such as bioprinting.(5) Animal tests”*
  • Provided the Medical Device Development Tools (MDDT) program: “a way for the FDA to qualify tools that medical device sponsors can choose to use in the development and evaluation of medical devices”
  • The US Environmental Protection Agency has published a New Approaches Work Methods Work Plan which has some crossover with medical products.
  • The FDA Modernization Act 3.0 (February 6th 2024) has been introduced In House “To amend the Federal Food, Drug, and Cosmetic Act to establish a process for the qualification of nonclinical testing methods to reduce and replace the use of animals in nonclinical research, improve the predictivity of nonclinical testing methods, and reduce development time for a biological product or other drug, and for other purposes”. 
  • The FDA’s CDER and CBER Drug Development Tool (DDT) Qualification Project Search database can be used to search DDT Qualification programs by NAM stage of submission, qualification status, disease and therapeutic area.                 .

New Drugs and Clinical Trial Rules (2023) has been passed by the Government of India which aims to replace the use of animals in research, especially in drug testing.

The amendment authorises researchers to instead use non-animal and human-relevant methods, including technologies like 3D organoids, organs-on-chip, and advanced computational methods, to test the safety and efficacy of new drugs.
These rules mandate that any CRO conducting a clinical trial or bioavailability/bioequivalence study of new drugs or investigational drugs in human subjects must obtain registration from the Central Licensing Authority before conducting any such studies.

In South Korea, two bills were introduced at the National Assembly; the Act on the Promotion of Development, Dissemination and Use of Alternatives to Animal Testing Methods (PAAM Act), sponsored by Assembly member In-Soon Nam in 2020, and the Act on the Vitalization of Development, Dissemination, and Use of Alternatives to Animal Testing Methods (VAAM Act), sponsored by Assembly member Jeoung Ae Han in 2022.

The Korean Center for the Validation of Alternative Methods (KoCVAM) has been operated within the Ministry of Food and Drug Safety (MFDS) since 2009 in order to introduce alternative test methods or new approach methodologies (NAMs) in safety assessment and to support the promotion and utilisation of NAMs. Read the MFDS NAMs report here. 

• Medicines and Medical Devices Safety Authority (Medsafe) is the regulator of medicines and medical devices in New Zealand.
  Medsafe is a business unit of the Ministry of Health.
• Medsafe’s role is to ensure that medicines and medical devices sold or distributed in New Zealand are safe and effective, and they regulate legislatively under the Medicines Act 1981 and Medicines Regulations 1985, both of which are available here.
• When assessing medicine applications, in assessing the chemical, pharmaceutical and biological data submitted with new medicine applications and changed medicine notifications, Medsafe generally follows the technical guidelines published by the International Conference on Harmonisation (ICH), the European Commission and its Committee for Proprietary Medicinal Products (CPMP), and the United States Food and Drug Administration (FDA), as well as the technical guidance provided by the British, European, and United States Pharmacopoeia (which Medsafe regards as essentially equivalent and equally acceptable standards).
• Where appropriate, Medsafe also takes notice of guidelines published by the World Health Organisation (WHO) and the Australian Therapeutic Goods Administration (TGA). Medsafe recognises these overseas guidelines from the dates on which they come into force internationally.
• A recent amendment to the Medicines Act 1981 means that another approval pathway is now available. The “verification pathway” allows a new medicine to be approved if two or more recognised authorities have granted full marketing authorisation
• Medsafe expects toxico-pharmacological studies and clinical studies supplied in support of any new medicine application or changed medicine application to have been carried out in accordance with the internationally accepted standards of Good Laboratory Practice and Good Clinical Research Practice. This information and more can be found in their Guidelines on the Regulation of Therapeutic Products in New Zealand.
• Pharmac then decides which medicines and related products are government funded.Pharmac is a Crown entity —specifically a Crown agent (which is a type of statutory entity) —governed by a board. Members of the board are accountable to the responsible Minister who can direct Pharmac to give effect to government policy

Specific testing guidelines or agreements that are required in the regulatory setting:

• The OECD Guidelines are the internationally agreed testing methods that are primarily used in regulatory safety testing and subsequent chemical notification and registration 
• Under Mutual Acceptance of Data principle, OECD countries and full adherents have agreed that a safety test carried out in accordance with the OECD Test Guidelines and Principles of Good Laboratory Practice in one OECD country must be accepted by other OECD countries for assessment purposes.
• OECD supports Integrated approaches to testing and assessment (IATA).
• IATA combine multiple sources of information to conclude on the toxicity of chemicals, and this information is generated by new technologies and methods, such as in silico, in chemico and in vitro approaches, that reduce the need for animal testing, enabling toxicity testing that is faster, less expensive, and more relevant to human responses than traditional toxicity testing methods
• IATAs are increasingly based on methods that measure or predict key events from Adverse outcome pathways (AOPs) relevant to the biological effect of interest
• AOPs are “an analytical construct that describes a sequential chain of causally linked events at different levels of biological organisation that lead to an adverse health or ecotoxicological effect. AOPs are the central element of a toxicological knowledge framework being built to support chemical risk assessment based on mechanistic reasoning.” 
• The OECD  knowledge base and tools such as the AOP wikipedia which is a collaborative effort between the EU JRC and the US Environmental Protection Agency
• The OECD has a series of educational webinars to promote knowledge sharing on emerging science to chemical safety testing 
• The international Council for Animal Protection in OECD programs publishes a list of all globally harmonised non-animal methods
• WHO Guidelines for Biologicals are available here.
• Read a NCRSs Review of animal use requirements in WHO biologics guidelines | NC3Rs

ISO Standards

ISO Standards for Medical Devices can be viewed here. 

• NURA: Toxicology training on non-animal methods 
• Master Class in Animal-Free Safety: Self-paced online course on testing in cosmetics and chemicals 
• Toxicology 21 (Coursera): Seven-module course from global experts 
• Survey: Regulators’ learning needs for NAMs in research and regulatory testing

The following resources have been produced by organisations which work to reduce animal testing in the regulatory setting:

• Webinar recording on how the pharmaceutical industry is working to avoid and replace the use of animals for scientific purposes
• Physicians Committee for Responsible Medicine (PCRM) New Approach Methodology (NAM) Use for Regulatory Application (NURA) education program 
• PCRM Dynamic discussions workshop recording
• Roche Institute of Human Biology
• Recordings from NC3Rs workshop on increasing confidence in NAMS for regulatory decision making. 
• VAC2VAC aims to provide data to support the ‘consistency approach’ for quality control that promotes the use of in vitro, analytical, non-animal based systems. The project brings together scientists from both the human and veterinary pharmaceutical industry along with academia and regulators. Together they plan to develop and validate non-animal tests; generate vaccine specific toolkits of consistency tests; increase our scientific understanding of vaccine quality; and contribute to the regulatory acceptance and routine use of non-animal tests during vaccine quality control testing.
• NAM navigator– innovative knowledge portal to navigate valuable information on the development, standardization, validation and acceptance of New Approach Methodologies (NAMs).
• NAMS network featuring a database, providers and relevant documentation 

Further reading and tools: 

Certara Non-Animal Navigator™

AI assisted medicine development 

A history of animal use in regulatory science what can we learn?

Medical Devices and regulatory testing

Replacing Animal Tests to Improve Safety for Humans
Kathy Archibald, Robert Coleman, Tamara Drake
Animal Experimentation: Working Towards a Paradigm Change, 2019, pp. 417-442 

Replacing Animal Tests to Improve Safety for Humans

Guidance Snapshot Pilot | FDA

UK Government confirms no legal requirement for animal testing in medical research – Animal Free Research UK and written response from UK Health Department.

Publications Co-authored by FDA on Alternative Methods | FDA

Legislation and Regulation – FRAME 

A report on the “Regulatory barriers to the adoption of in silico trials” by In Silico World 

Incorporating New Approach Methodologies into Regulatory Nonclinical Pharmaceutical Safety Assessment (Workshop Report)

The Need for Guidance in Antidepressant Drug Development: Revisiting the Role of the Forced Swim Test and Tail Suspension Test

ECHAs Key Areas of Regulatory Challenge 2023 Update included 2.3 Shift away from animal testing

FDA’s ISTAND Pilot Program accepts a submission of first organ-on-a-chip technology designed to predict human drug-induced liver injury.

Read about Digital Animal Replacement Technology Solutions (DART)

Potential Approaches to Drive Future Integration of New Alternative Methods for Regulatory Decision-Making (FDA)

NAM Use for Regulatory Application – Human-based methods in FDA submissions

Critical Path Institute – The Path Forward in Drug Development

Complex In Vitro Model: Qualification Framework Public Workshop

Focus Group Organ-on-Chip Standardization Roadmap

Incorporating NAMs into medicines development: Insights from regulators, industry and academia

The Decision Tree approach as a strategy for the global phase out of animal testing for acute and local toxicity for chemicals: recommendations from an expert workshop