Comparison of new Brazilian legislation for the approval of advanced therapy medicinal products with existing systems in the USA,European Union and Japan |
| |
| Affiliation: | 1. Brazilian Health Regulatory Agency, Brasília, Brazil;2. Faculty of Health Sciences, University of Brasília, Brasília, Brazil;1. Inpatients Department, Nanjing Qi-xia Xi-gang Community Health Service Centers, Nanjing, China;2. Research and Development Department, Nanjing Regenerative Medicine Engineering and Technology Research Center, Nanjing, China;1. Biotherapy Center, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China;2. Cancer Center, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China;3. Henan Key Laboratory for Tumor Immunology and Biotherapy, Zhengzhou, China;4. School of Life Sciences, Zhengzhou University, Zhengzhou, China;5. State Key Laboratory of Esophageal Cancer Prevention and Treatment, Zhengzhou, China;1. Department of Orthopaedics, Government Medical College and Hospital, Dindigul, Tamil Nadu, India;2. Department of Biotechnology, School of Engineering and Technology, Sharda University, Greater Noida, Uttar Pradesh, India;3. Indian Stem Cell Study Group (ISCSG) Association, Lucknow, Uttar Pradesh, India;4. Department of Orthopaedics, Government Medical College and Hospital, Karur, Tamil Nadu, India;5. Department of Orthopaedics, School of Medical Sciences and Research, Sharda University, Greater Noida, Uttar Pradesh, India;6. Department of Orthopaedics, Sanjay Gandhi Institute of Trauma & Orthopaedics, Bengaluru, Karnataka, India;7. Fellow in Orthopaedic Rheumatology, Dr. RML National Law University, Lucknow, Uttar Pradesh, India;8. Department of Orthopaedics, Faculty of Medicine - Sri Lalithambigai Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai, Tamil Nadu, India;1. Department of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA;2. Departments of Medicine and Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA;3. Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA;4. Department of Medical Physics, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA;5. Program for Advanced Cell Therapy, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA;6. Departments of Biostatistics & Medical Informatics and Statistics, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA;7. Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA;8. Department of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA;1. John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey, USA;2. Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York, USA;3. Vitalant Biotherapies, Phoenix, Arizona, USA;4. University of Texas Health Science Center San Antonio, Department of Pathology Transfusion Medicine, San Antonio, Texas, USA;5. Canadian Blood Services, Ottawa, Ontario, Canada;6. Blood & Marrow Transplantation and Cellular Therapy Stanford Health Care, Stanford, California, USA;7. BioLife Solutions, Inc. Bothell, Washington, USA;8. Héma-Québec, Montreal, Quebec, Canada;9. Northside Hospital, Blood and Marrow Transplant Program, Cell Therapy Lab, Atlanta, Georgia, USA;10. Dana-Farber Cancer Institute Cell Manipulation Core Facility, Boston, Massachusetts, USA;11. Division of Hematology/Oncology, Department of Medicine, University of Illinois College of Medicine, Chicago, Illinois, USA |
| |
| Abstract: | Background aimsAdvanced therapy medicinal products (ATMPs) are a class of biological products for human use that are based on genes, cells and tissues. The first ATMP received marketing authorization in Europe in 2009, whereas Brazil granted the first authorization in 2020. The objective of this study was to compare the regulatory models adopted by Brazil, the USA, Japan and the European Union, which comprise the member countries of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, with regard to the marketing authorization of ATMPs.MethodsThe authors performed a review of the scientific literature and official documents of the regulatory agencies in the aforementioned countries.ResultsThe legislation and regulatory guidelines adopted by the regulatory agencies exhibit similarities and differences. It was not possible to assess whether these differences can be translated into divergent final recommendations by regulatory authorities upon a request for marketing authorization.ConclusionsIn the future, it will be appropriate to start a progressive process of harmonization between these agencies in terms of terminology, legal recommendations and characterization requirements. This is particularly important for emerging countries such as Brazil. In this sense, some measures can be taken to achieve alignment between regulators. |
| |
| Keywords: | |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
