Project Orbis

<!DOCTYPE html> <html lang="en" dir="ltr" prefix="og: https://ogp.me/ns#"> <head> <meta charset="utf-8" /> <script async src="https://www.googletagmanager.com/gtag/js?id=G-273DTKB5QW"></script> <meta name="description" content="Information Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE) that provides a framework for concurrent submission and review of oncology products among international partners." /> <meta name="dcterms.title" content="Project Orbis" /> <meta name="dcterms.creator" content="Office of the Commissioner" /> <meta name="dcterms.description" content="Information Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE) that provides a framework for concurrent submission and review of oncology products among international partners." /> <meta name="dcterms.publisher" content="FDA" /> <meta name="dcterms.type" content="Article" /> <meta name="dcterms.source" content="FDA" /> <meta property="og:site_name" content="U.S. Food and Drug Administration" /> <meta property="og:type" content="Article" /> <meta property="og:url" content="https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis" /> <meta property="og:title" content="A framework for concurrent submission and review of oncology products" /> <meta property="og:description" content="A framework for concurrent submission and review of oncology products " /> <meta property="og:image" content="https://www.fda.gov/files/OCE_ProjectObisStethFinalPhotoNOTextWeb_0.jpg" /> <meta property="og:updated_time" content="Tue, 09/10/2024 - 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main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-2" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">Project Orbis</h1> <p class="article-subtitle text-center">A framework for concurrent submission and review of oncology products </p> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fabout-fda%2Foncology-center-excellence%2Fproject-orbis" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=Project%20Orbis&url=https://www.fda.gov%2Fabout-fda%2Foncology-center-excellence%2Fproject-orbis" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li class="lcds-share__item hidden-xs"> <a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.fda.gov%2Fabout-fda%2Foncology-center-excellence%2Fproject-orbis&title=Project%20Orbis&source=FDA" class="lcds-share__btn lcds-share--default__btn-linkedin js-share" id="linkedin-share" target="_blank"><span class="fa icon-linkedin" aria-hidden="true"></span>Linkedin</a> </li> <li class="lcds-share__item"> <a href="mailto:?subject=Project%20Orbis&body=https://www.fda.gov%2Fabout-fda%2Foncology-center-excellence%2Fproject-orbis" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <figure> <div> <div class="field field--name-image field--type-image field--label-inline"> <div class="field--label">Image</div> <div class="field--item"> <picture> <source srcset="/files/styles/main_image_small/public/OCE_ProjectObisStethFinalPhotoNOTextWeb_0.jpg?itok=9947esb3 1x" media="all and (max-width: 320px)" type="image/jpeg" width="320" height="180"/> <source srcset="/files/styles/main_image_medium/public/OCE_ProjectObisStethFinalPhotoNOTextWeb_0.jpg?itok=hBFaWKiL 1x" media="all and (min-width: 321px) and (max-width: 480px)" type="image/jpeg" width="500" height="281"/> <source srcset="/files/styles/main_image_medium/public/OCE_ProjectObisStethFinalPhotoNOTextWeb_0.jpg?itok=hBFaWKiL 1x" media="all and (min-width: 481px) and (max-width: 767px)" type="image/jpeg" width="500" height="281"/> <source srcset="/files/styles/main_image_medium/public/OCE_ProjectObisStethFinalPhotoNOTextWeb_0.jpg?itok=hBFaWKiL 1x" media="all and (min-width: 768px) and (max-width: 992px)" type="image/jpeg" width="500" height="281"/> <source srcset="/files/styles/main_image_1/public/OCE_ProjectObisStethFinalPhotoNOTextWeb_0.jpg?itok=YMXCMfyn 1x" media="all and (min-width: 993px) and (max-width: 1200px)" type="image/jpeg" width="1020" height="574"/> <source srcset="/files/styles/main_image_1/public/OCE_ProjectObisStethFinalPhotoNOTextWeb_0.jpg?itok=YMXCMfyn 1x" media="all and (min-width: 1201px)" type="image/jpeg" width="1020" height="574"/> <img loading="eager" src="/files/styles/main_image_medium/public/OCE_ProjectObisStethFinalPhotoNOTextWeb_0.jpg?itok=hBFaWKiL" width="500" height="281" alt="Project Orbis" class="img-responsive" /> </picture> </div> </div> </div> </figure> <p>The FDA Oncology Center of Excellence (OCE) initiated Project Orbis in May 2019 to provide a framework for concurrent submission and review of oncology products among international partners.</p> <p>Collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions, regardless of whether the product has received FDA approval. Pivotal clinical trials in oncology are commonly conducted internationally and these global trials are increasingly important for investigating the safety and effectiveness of cancer drugs for approval in the United States. Future drug development may benefit by establishing a greater uniformity of new global standards of treatment, leading to the optimal design of these important trials.</p> <p>Since its inception, Project Orbis has received many oncology marketing applications and led to the approval of numerous oncology drugs for patients across the world. For more information, please refer to the Project Orbis approval report.</p> <h3>Learn more about Project Orbis</h3> <div class=" panel-group" id="accordion_758097" role="tablist" aria-multiselectable="true"> <div title="Meet the Team" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_67466accb8717"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#67466accb8717" aria-controls="67466accb8717">Meet the Team</a> </h2> </div> <div id="67466accb8717" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_67466accb8717"> <div class="panel-body"> <div alt="Dr. Angelo De Claro" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_800_x_450 Array" data-entity-type="media" data-entity-uuid="cfc09b09-7854-4d51-95f1-01548b8ed5da" data-langcode="en" title="Dr. Angelo De Claro" class="align-left embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_800_x_450/public/De%20Claro_Apr2023.jpg?itok=WzXhgG71" alt="Dr. Angelo De Claro" title="Dr. Angelo De Claro" class="img-responsive"> </div> <p>R. Angelo de Claro is a hematology-oncology physician and currently the Associate Director (Acting) for Global Clinical Sciences with the Oncology Center of Excellence. In this role, he leads OCE efforts to advance cancer drug development and regulatory science across the globe, including direction of Project Orbis. Dr. de Claro is also the Division Director for the Division of Hematologic Malignancies I in the Office of Oncologic Diseases, Center for Drug Evaluation and Research, FDA.</p> <hr> <div alt="Dianne Spillman" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_800_x_450 Array" data-entity-type="media" data-entity-uuid="66bf2217-813c-43a2-8a25-fe7509d94ae2" data-langcode="en" title="Dianne Spillman" class="align-left embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_800_x_450/public/Dianne%20Spillman.jpg?itok=kRrm4Vgk" alt="Dianne Spillman" title="Dianne Spillman" class="img-responsive"> </div> <p>Dianne Spillman is the Associate Director for Global Regulatory Outreach in the Oncology Center of Excellence. She holds a Bachelor of Science in Biology from Northeastern University, Boston, MA. Her government career spans 30 years, with 27 of those years with FDA oncology Divisions and Offices. Dianne started in 1990 as a research assistant with the Veterinary Research Program at the National Center for Research Resources, National Institutes of Health. In 1993, she joined the FDA/CDER Division of Oncology and Pulmonary Drug Products as a project manager. Between 2002-2005, she served as Special Assistant to Dr. Richard Pazdur, then the Director of the Division of Oncology Drug Products. From late 2005-early 2019, she was the Lead Project Manager for the Oncology Program in the Office of Hematology and Oncology Products. Currently, Dianne facilitates OCE interactions with foreign regulatory counterparts and was instrumental in the first international collaborative review between Australia, Canada, and the US under Project Orbis.</p> <hr> <div alt="Lauren Hotaki" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_800_x_450" data-entity-type="media" data-entity-uuid="e5fdbfc1-6e99-4626-83c5-d0ebf6a84d91" data-langcode="en" title="Lauren Hotaki" class="align-left embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_800_x_450/public/Image-1_0.jpg?itok=bYvVBp-f" alt="Lauren Hotaki" title="Lauren Hotaki" class="img-responsive"> </div> <p>Lauren Tesh Hotaki is a Senior Health Scientist in the OCE. She holds a Doctor of Pharmacy degree from The Philadelphia College of Pharmacy, Philadelphia, PA, and board certification in Pharmacotherapy (2012) and Infectious Diseases from the Board of Pharmacy Specialties. Lauren has been in government service since high school as an intern at the Center for Veterans Enterprise, an agency of the Department of Veteran Affairs (VA) and as a pharmacy technician during pharmacy school at the Washington, DC VA Medical Center. Prior to FDA, Lauren was an Assistant Professor of Pharmacy Practice at the South College School of Pharmacy in Knoxville, TN, and completed two years of post-graduate pharmacy training in infectious diseases at Lee Health in Fort Myers, FL. She resumed her government career in 2014 as the Designated Federal Officer for the Oncologic Drugs and Antimicrobial Drugs Advisory Committees at the FDA. She joined OCE and the Project Orbis team in 2020. Currently, Lauren manages applications with foreign regulatory counterparts under Project Orbis, facilitates international communication and assists with OCE internal planning for advisory committee meetings.</p> <hr> <div alt="Ynghua Wang" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_800_x_450" data-entity-type="media" data-entity-uuid="9b65b85a-bb5b-497c-b352-7a59f41ba4a4" data-langcode="en" title="Ynghua Wang" class="align-left embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_800_x_450/public/Ynghua%20Wang.jpg?itok=aSDyzs08" alt="Ynghua Wang" title="Ynghua Wang" class="img-responsive"> </div> <p>Yinghua Wang is a Senior Health Scientist in the OCE. She holds a Doctor of Pharmacy degree from University of Maryland Baltimore School of Pharmacy, a Master of Public Health degree from Johns Hopkins University Bloomberg School of Public Health, and Regulatory Affair Certification. Prior to joining the FDA, Yinghua was the Managing Editor for a drug information database at Thomson Reuters. Yinghua started at FDA’s Center for Drug Evaluation and Research in 2008, first in the Office of Surveillance and Epidemiology as a safety evaluator, then in the Division of Advisory Committee and Consultant Management as a Conflict-of-Interest analyst, Designated Federal Officer, and Branch Chief of Advisory Committee Management. She joined the OCE International team in January 2021, managing Project Orbis applications and facilitating communication with our international regulatory counterparts.</p> <hr> <div alt="Tina Macaulay" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="landscape_16_9_800_x_450" data-entity-type="media" data-entity-uuid="47c50577-8d9f-4ba9-8311-c65f726ca05f" data-langcode="en" title="Tina Macaulay" class="align-left embedded-entity"> <img loading="lazy" src="/files/styles/landscape_16_9_800_x_450/public/Tina%20Macaulay.jpg?itok=Bx6AS4Wt" alt="Tina Macaulay" title="Tina Macaulay" class="img-responsive"> </div> <p>Tina MacAulay is a Regulatory Information Specialist in the OCE. Tina joined the FDA/CDER in 2017 as a Project Specialist, Project Management and Analysis Staff servicing the Division of Hematology, Oncology Toxicology Products and Division of Pharm/Tox of Rare Diseases, Pediatrics, Urologic & Reproductive Medicine. Currently within OCE, Tina manages shared information and oversees project implementation for international collaboration, Project Orbis, pharmacy student rotations, ODAC member, and travel.</p> </div> </div> </div> </div> <div class=" panel-group" id="accordion_758371" role="tablist" aria-multiselectable="true"> <div title="Project Orbis Partners" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_67466accb9188"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#67466accb9188" aria-controls="67466accb9188">Project Orbis Partners</a> </h2> </div> <div id="67466accb9188" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_67466accb9188"> <div class="panel-body"> <h3>Project Orbis Partners</h3> <p>The U.S Food and Drug Administration together with the Australian Therapeutic Goods Administration (TGA) and Health Canada (HC) took part in the first Project Orbis collaborative review. Since then, other countries have joined and become Project Orbis Partners (POP).</p> <ul> <li><a href="https://www.tga.gov.au/project-orbis">Australian Therapeutics Goods Administration (TGA)</a></li> <li><a href="https://www.gov.br/anvisa/pt-br">Brazil's National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária [ANVISA])</a></li> <li><a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/international-activities/project-orbis.html">Health Canada (HC)</a></li> <li><a href="https://www.gov.il/en/Departments/Guides/project-orbis">Israel Ministry of Health (IMoH) Pharmaceutical Administration</a></li> <li><a href="https://www.google.com/url?esrc=s&q=&rct=j&sa=U&url=https://www.hsa.gov.sg/&ved=2ahUKEwi94czeo7HzAhXcMVkFHV5dBJsQFnoECAgQAg&usg=AOvVaw1k_jpIYoOrnAoNRtjQguu1">Singapore Health Sciences Authority (HSA)</a></li> <li><a href="https://www.swissmedic.ch/swissmedic/en/home.html">Switzerland Swissmedic</a></li> <li><a href="https://www.gov.uk/guidance/guidance-on-project-orbis">United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA)</a></li> </ul> </div> </div> </div> </div> <div class=" panel-group" id="accordion_758561" role="tablist" aria-multiselectable="true"> <div title="Select News, Presentations and Publications" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_67466accb9289"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#67466accb9289" aria-controls="67466accb9289">Select News, Presentations and Publications</a> </h2> </div> <div id="67466accb9289" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_67466accb9289"> <div class="panel-body"> <h3>Select News, Presentations and Publications</h3> <ul> <li>Hotaki, L.T., Shrestha, A., Bennett, M.P. et al. <a href="https://doi.org/10.1007/s43441-023-00522-4">Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners</a>. Ther Innov Regul Sci 57, 875–885 (2023).</li> <li>Matea Zosso-Pavic, Qiyu Li, Eiman Atiek, Anita Wolfer, Ulrich-Peter Rohr. <a href="https://doi.org/10.1016/S1470-2045(24)00158-X">Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis</a>. The Lancet Oncology,2024,ISSN 1470-2045.</li> <li>FDA Ground Rounds: <a href="/science-research/fda-grand-rounds/project-orbis-global-collaborative-oncology-review-program-05132021-05132021">Project Orbis by R. Angelo de Claro, MD</a></li> <li>FDA News Release: <a href="/news-events/press-announcements/fda-takes-first-action-under-new-international-collaboration-australia-and-canada-designed-provide">FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma</a></li> <li>FDA News Release: <a href="/news-events/fda-voices/project-orbis-strengthening-international-collaboration-oncology-product-reviews-faster-patient">Strengthening International Collaboration for Oncology Product Reviews, Faster Patient Access to Innovative Therapies</a></li> <li>Publication: Project Orbis: <a href="https://clincancerres.aacrjournals.org/content/26/24/6412">Collaborative Review Program</a></li> </ul> </div> </div> </div> </div> <div class=" panel-group" id="accordion_758729" role="tablist" aria-multiselectable="true"> <div title="Frequently Asked Questions" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_67466accb933e"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#67466accb933e" aria-controls="67466accb933e">Frequently Asked Questions</a> </h2> </div> <div id="67466accb933e" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_67466accb933e"> <div class="panel-body"> <h3>Frequently Asked Questions</h3> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="2fe75b92-3695-4071-8039-6c8a0f0a2793" href="/about-fda/oncology-center-excellence/project-orbis-frequently-asked-questions" title="Project Orbis Frequently Asked Questions">Project Orbis FAQs</a></li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="4aa553c7-bfa2-4260-be1f-6086a2a65e8a" href="/media/165101/download?attachment" title="Project Orbis Types Table-v2 (Reb. Jan 2023)">Project Orbis Types</a></li> </ul> </div> </div> </div> </div> <div class=" panel-group" id="accordion_758898" role="tablist" aria-multiselectable="true"> <div title="Orbis Documents" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_67466accb93ec"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#67466accb93ec" aria-controls="67466accb93ec">Orbis Documents</a> </h2> </div> <div id="67466accb93ec" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_67466accb93ec"> <div class="panel-body"> <h3>Orbis Documents</h3> <ul> <li><a href="/about-fda/oncology-center-excellence/assessment-aid">Assessment Aid (AAid)</a> <ul> <li>Please contact the review division for most current template.</li> </ul> </li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="6f57daca-1c79-42f9-b2fe-6d4a6c361898" href="/media/155970/download?attachment" title="Sponsor Authorization - Foreign Government Orbis 2022 (SAL TEMPLATE)">Sponsor Authorization Letter (SAL) Template</a> <ul> <li>Instructions: <ol> <li>FDA Component Contact Name: Office of Oncologic Disease Division Director</li> <li>Each agency should have a separate authorization and include the appropriate contacts from the respective agency.</li> <li>For the [insert description of purpose] section: this should be state “…the review by FDA and [ANVISA, HC, HSA, MHRA, IMoH, Swissmedic, TGA] of the [product established name] applications.”</li> <li>For the information to be shared section: this should state, “Any data or information regarding NDA/BLA/supplement xxxxxx”</li> </ol> </li> </ul> </li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="6e8c90a1-853a-4554-83db-dad4065bdc10" href="/media/178535/download?attachment" title="project_orbis_request_for_participation_and_gsp.docx">Project Orbis Request for Participation and Global Submission Plan (GSP)</a> <ul> <li>General Agency Contacts <ul> <li>Australian TGA:<br> <a href="mailto:pmabinternationalevaluations@health.gov.au">PMABinternationalevaluations@health.gov.au</a></li> <li>Brazil ANVISA: <a href="mailto:projectorbis@anvisa.gov.br">projectorbis@anvisa.gov.br</a></li> <li>Canada HC: <a href="mailto:collaboration@hc-sc.gc.ca">collaboration@hc-sc.gc.ca</a></li> <li>Israel MoH: <a href="mailto:project_orbis@MOH.GOV.IL">project_orbis@MOH.GOV.IL</a></li> <li>Singapore HSA: <a href="mailto:hsa_tp_Enquiry@hsa.gov.sg">HSA_TP_Enquiry@hsa.gov.sg</a></li> <li>Switzerland Swiss Medic: <a href="mailto:projectorbis@swissmedic.ch">ProjectOrbis@swissmedic.ch</a></li> <li>United Kingdom MHRA: <a href="mailto:orbis-mhra@mhra.gov.uk">Orbis-MHRA@mhra.gov.uk</a></li> <li>U.S. FDA: <a href="mailto:projectorbis@fda.hhs.gov">ProjectOrbis@fda.hhs.gov</a></li> </ul> </li> </ul> </li> </ul> </div> </div> </div> </div> <div class=" panel-group" id="accordion_759060" role="tablist" aria-multiselectable="true"> <div title="Orbis Approvals" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_67466accb9491"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#67466accb9491" aria-controls="67466accb9491">Orbis Approvals</a> </h2> </div> <div id="67466accb9491" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_67466accb9491"> <div class="panel-body"> <h3>Orbis Approvals</h3> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="62040604-ac33-4f79-b0c5-55258423d7e6" href="/media/181761/download?attachment" title="external_only_po_web_database_10_sept_2024.xlsx">Project Orbis Approvals</a> (as of September 10, 2024)</li> <li>Please note: <ul> <li>This report will be updated quarterly.</li> <li>FDA approval dates do not necessarily reflect Project Orbis Partner (POP) approval dates.</li> <li>A product might be approved in a POP country through a different approval pathway and will not be listed here if it was not part of Project Orbis.</li> </ul> </li> <li>POP Approval Websites <ul> <li>Australia’s Therapeutic Goods Administration <ul> <li><a href="https://www.tga.gov.au/resources/artg">Australian Register of Therapeutic Goods</a></li> <li><a href="https://www.tga.gov.au/resources/prescription-medicines-registrations">Prescription medicines registration database</a></li> </ul> </li> <li>Brazil's National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária [ANVISA]) <ul> <li><a href="https://consultas.anvisa.gov.br/#/medicamentos/">Medicines</a> (Portuguese only; use Google Chrome to translate into English)</li> </ul> </li> <li>Health Canada <ul> <li><a href="https://hpr-rps.hres.ca/">The Drug and Health Product Register</a></li> <li><a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html">Drug Product Database: Access the database</a></li> </ul> </li> <li>Israel’s Ministry of Health (Pages below published monthly in Hebrew; use Google Chrome to translate into English) <ul> <li><a href="https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/Registration/Pages/NewIsraeliDruds.aspx">New Drugs</a></li> <li><a href="https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/Registration/Pages/Label-changes-registered-preparations.aspx">New Or Updated Indications</a></li> <li><a href="https://israeldrugs.health.gov.il/#!/byDrug">Israeli Drug Registry</a></li> </ul> </li> <li>Singapore’s Health Sciences Authority <ul> <li><a href="https://eservice.hsa.gov.sg/prism/common/enquirepublic/SearchDRBProduct.do?action=load">Online Infosearch- Register of Therapeutic Products</a></li> </ul> </li> <li>Swissmedic <ul> <li><a href="https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/new-medicines.html">Initial approvals of NASs/BLAs</a></li> <li><a href="https://www.swissmedic.ch/swissmedic/en/home/about-us/publications/swissmedic-journal.html">Indication extensions are published in the monthly Swissmedic Journal (SMJ)</a></li> <li><a href="https://www.swissmedic.ch/swissmedic/en/home/about-us/international-collaboration/multilateral-co-operation-with-international-organisations---ini/multilateral-co-operation-with-international-organisations---ini/work-sharing-zl-swissmedic.html">Access Consortium work-sharing authorisations</a></li> <li><a href="https://www.swissmedicinfo.ch/?Lang=EN">Swiss Database of Product Information for Professionals and Patients</a></li> <li><a href="https://www.swissmedic.ch/swissmedic/en/home/about-us/publications/swisspar.html">Swiss Public Assessment Reports for New Active Substances</a></li> </ul> </li> <li>United Kingdom’s Medicines and Healthcare products Regulatory Agency <ul> <li><a href="https://www.gov.uk/government/collections/marketing-authorisations-lists-of-granted-licences">Marketing authorisations</a></li> <li><a href="https://products.mhra.gov.uk/">Approved Products</a></li> </ul> </li> </ul> </li> </ul> </div> </div> </div> </div> <h3>Additional Information</h3> <ul> <li><a href="/about-fda/fda-organization/oncology-center-excellence">FDA Oncology Center of Excellence</a></li> <li><a href="/about-fda/oncology-center-excellence/real-time-oncology-review">Real-Time Oncology Review</a></li> <li><a href="/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review">FDA: Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review</a></li> </ul> <h3>Contact Information</h3> <p>For additional questions please contact <a href="mailto:projectorbis@fda.hhs.gov">ProjectOrbis@fda.hhs.gov</a></p> <p> </p>   </div> <aside class="col-md-2 col-md-push-2" 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