Cargando…

Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States

Advanced therapy medicinal products (ATMPs) are a fast-growing field of innovative therapies. The European Union (EU) and the United States (US) are fostering their development. For both regions, ATMPs fall under the regulatory framework of biological products, which determines the legal basis for t...

Descripción completa

Detalles Bibliográficos
Autores principales:	Iglesias-Lopez, Carolina, Agustí, Antonia, Obach, Mercè, Vallano, Antonio
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Frontiers Media S.A. 2019
Materias:	Pharmacology
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6728416/ https://www.ncbi.nlm.nih.gov/pubmed/31543814 http://dx.doi.org/10.3389/fphar.2019.00921

Ejemplares similares

Corrigendum: Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States
por: Iglesias-Lopez, Carolina, et al.
Publicado: (2020)

Methodological Characteristics of Clinical Trials Supporting the Marketing Authorisation of Advanced Therapies in the European Union
por: Iglesias-Lopez, Carolina, et al.
Publicado: (2021)

Current landscape of clinical development and approval of advanced therapies
por: Iglesias-Lopez, Carolina, et al.
Publicado: (2021)

The challenges of access to innovative medicines with limited evidence in the European Union
por: Vallano, Antonio, et al.
Publicado: (2023)

Contribution of patient registries to regulatory decision making on rare diseases medicinal products in Europe
por: Jonker, Carla J., et al.
Publicado: (2022)

Comparison of pharmacogenomic information for drug approvals provided by the national regulatory agencies in Korea, Europe, Japan, and the United States
por: Lee, Mijin, et al.
Publicado: (2023)

Advanced Therapy Medicinal Products for the Eye: Definitions and Regulatory Framework
por: López-Paniagua, Marina, et al.
Publicado: (2021)

Implementing reflective multicriteria decision analysis (MCDA) to assess orphan drugs value in the Catalan Health Service (CatSalut)
por: Guarga, Laura, et al.
Publicado: (2019)

Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development
por: Ancans, Janis
Publicado: (2012)

Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications
por: Miljković, Nenad, et al.
Publicado: (2020)

Assessment of the effectiveness and efficiency of the economic community of West African States Medicines Regulatory Harmonization initiative by the pharmaceutical industry
por: Owusu-Asante, Mercy, et al.
Publicado: (2023)

Introduction and Utilization of High Priced HCV Medicines across Europe; Implications for the Future
por: de Bruijn, Winnie, et al.
Publicado: (2016)

Adverse Drug Reactions in Pediatric Oncohematology: A Systematic Review
por: Amaro-Hosey, Kristopher, et al.
Publicado: (2022)

Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe
por: Vreman, Rick A., et al.
Publicado: (2020)

New pricing models for generic medicines to ensure long-term sustainable competition in Europe
por: Francois, Clement, et al.
Publicado: (2023)

Editorial: Drug development of herbal medicines: Regulatory perspectives
por: Bilia, Anna Rita, et al.
Publicado: (2022)

Mapping of Current Obstacles for Rationalizing Use of Medicines (CORUM) in Europe: Current Situation and Potential Solutions
por: Gad, Mohamed, et al.
Publicado: (2020)

Health Technology Assessment of Advanced Therapy Medicinal Products: Comparison Among 3 European Countries
por: Gozzo, Lucia, et al.
Publicado: (2021)

Advancing herbal medicine: enhancing product quality and safety through robust quality control practices
por: Wang, Hongting, et al.
Publicado: (2023)

A Review of the Dose Justification of Phase 3 Trials to Regulatory Authorities for Drugs Intended for the Treatment of Type 2 Diabetes in Europe
por: Koomen, Jeroen V., et al.
Publicado: (2021)

Chemical analysis of snus products from the United States and northern Europe
por: Lawler, Tameka S., et al.
Publicado: (2020)

How can patient preferences be used and communicated in the regulatory evaluation of medicinal products? Findings and recommendations from IMI PREFER and call to action
por: Janssens, Rosanne, et al.
Publicado: (2023)

Nanomedicines and Nanosimilars—Why a Robust Centralised Regulatory Framework Is Essential to Enhance Patient Safety
por: Isles, Michael P.
Publicado: (2022)

Variation in adverse drug reactions listed in product information for antidepressants and anticonvulsants, between the USA and Europe: a comparison review of paired regulatory documents
por: Cornelius, Victoria R, et al.
Publicado: (2016)

Phytochemical-based nanodrugs going beyond the state-of-the-art in cancer management—Targeting cancer stem cells in the framework of predictive, preventive, personalized medicine
por: Koklesova, Lenka, et al.
Publicado: (2023)

Chinese Herbal Medicine and Its Regulatory Effects on Tumor Related T Cells
por: Hoffman, Robert D., et al.
Publicado: (2020)

Access to medicines for rare diseases: A European regulatory roadmap for academia
por: Rosenberg, Noa, et al.
Publicado: (2023)

Effectiveness and safety of oral anticoagulants for non-valvular atrial fibrillation: a population-based cohort study in primary healthcare in Catalonia
por: Giner-Soriano, Maria, et al.
Publicado: (2023)

Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe
por: Farkas, Andreas M., et al.
Publicado: (2017)

Advances in computational frameworks in the fight against TB: The way forward
por: Naidu, Akshayata, et al.
Publicado: (2023)

Amorpha fruticosa – A Noxious Invasive Alien Plant in Europe or a Medicinal Plant against Metabolic Disease?
por: Kozuharova, Ekaterina, et al.
Publicado: (2017)

Advanced Therapy Medicinal Products and Exemptions to the Regulation 1394/2007: How Confident Can We be? An Exploratory Analysis
por: Van Wilder, Philippe
Publicado: (2012)

Comparison of BRICS-TM Countries' Biosimilar Regulatory Frameworks With Australia, Canada and Switzerland: Benchmarking Best Practices
por: Rahalkar, Hasumati, et al.
Publicado: (2021)

Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs
por: Giannuzzi, Viviana, et al.
Publicado: (2017)

Evaluation of the Performance of the Turkish Regulatory Agency: Recommendations for Improved Patients’ Access to Medicines
por: Koyuncu, Oguzhan, et al.
Publicado: (2020)

Variations in the Consumption of Antimicrobial Medicines in the European Region, 2014–2018: Findings and Implications from ESAC-Net and WHO Europe
por: Robertson, Jane, et al.
Publicado: (2021)

Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the member countries
por: Owusu-Asante, Mercy, et al.
Publicado: (2022)

Cost-Effectiveness of Nivolumab Plus Cabozantinib Versus Sunitinib as a First-Line Treatment for Advanced Renal Cell Carcinoma in the United States
por: Li, SiNi, et al.
Publicado: (2021)

Reimbursement of Orphan Drugs in Europe in Relation to the Type of Authorization by the European Medicines Agency and the Decision Making Based on Health Technology Assessment
por: Malinowski, Krzysztof Piotr, et al.
Publicado: (2018)

Corrigendum: Variations in the Consumption of Antimicrobial Medicines in the European Region, 2014–2018: Findings and Implications From ESAC-Net and WHO Europe
por: Robertson, Jane, et al.
Publicado: (2021)

Cannot write session to /tmp/vufind_sessions/sess_sp6u88992ikbc8p6rm4hqs5sok