European Conditional Marketing Authorization in a Rapidly Evolving Treatment Landscape: A Comprehensive Study of Anticancer Medicinal Products in 2006-2020.
Sign Up to like & getrecommendations! Published in 2023 at "Clinical pharmacology and therapeutics"
DOI: 10.1002/cpt.2906
Abstract: Since 2006, the European conditional marketing authorization (CMA) aims to facilitate timely patient access to medicinal products for which there is an unmet medical need by accepting less comprehensive data than normally required. The granting… read more here.
Keywords: european conditional; conditional marketing; marketing authorization; anticancer medicinal ... See more keywords
Hurdles in gene therapy regulatory approval: a retrospective analysis of European Marketing Authorization Applications.
Sign Up to like & getrecommendations! Published in 2019 at "Drug discovery today"
DOI: 10.1016/j.drudis.2018.12.007
Abstract: Gene therapy medicinal products (GTMPs) are innovative and promising treatment strategies. In Europe, the Committee for Advanced Therapies (CAT) is responsible for making marketing authorization recommendations to the Committee of Human Medicinal Products (CHMP). In… read more here.
Keywords: approval; marketing authorization; marketing; gene therapy ... See more keywords
Cell, tissue and gene products with marketing authorization in 2018 worldwide.
Sign Up to like & getrecommendations! Published in 2018 at "Cytotherapy"
DOI: 10.1016/j.jcyt.2018.09.010
Abstract: Cell and gene therapies (CGTs) are progressively entering into clinical practice in different parts of the world. The International Society for Cell & Gene Therapy (ISCT), a global scientific society, has been committed since 1992… read more here.
Keywords: marketing authorization; cell tissue; tissue gene; gene ... See more keywords
Analysis of GMP for marketing authorization of ATMPs: comparison in the US, the EU, Japan and South Korea.
Sign Up to like & getrecommendations! Published in 2022 at "Regenerative medicine"
DOI: 10.2217/rme-2021-0153
Abstract: Aim: This study compared regulatory systems of competent authorities related to GMP for marketing authorization of advanced therapy medicinal products (ATMPs). Methods: Dossiers for GMP and regulations and guidelines for facilities and equipment were analyzed… read more here.
Keywords: gmp marketing; authorization; japan south; south korea ... See more keywords
Evaluation of Companion Diagnostics in Scientific Advice and Drug Marketing Authorization Applications by the European Medicines Agency
Sign Up to like & getrecommendations! Published in 2022 at "Frontiers in Medicine"
DOI: 10.3389/fmed.2022.893028
Abstract: With the implementation of the new EU regulation on in vitro diagnostics (IVDR) in May 2022, notified bodies will be required to assess Companion Diagnostics (CDx). The EMA and national medicines agencies will be consulted… read more here.
Keywords: advice; marketing authorization; scientific advice; cdx ... See more keywords
Increase of Adverse Events After Intravenous Injection of Gentamicin in Horses Between 2015 and 2017—From Marketing Authorization Holder's Point of View
Sign Up to like & getrecommendations! Published in 2021 at "Frontiers in Veterinary Science"
DOI: 10.3389/fvets.2021.710571
Abstract: Between 2015 and 2017, a marked increase of anaphylactic-like reactions after intravenous administration of gentamicin was observed first in horses and, later, also in humans. This worldwide issue led to safety measures including product recalls… read more here.
Keywords: marketing authorization; gentamicin; authorization holder; safety ... See more keywords