Mobility endpoints in marketing authorisation of drugs: what gets the European medicines agency moving?
Sign Up to like & getrecommendations! Published in 2022 at "Age and Ageing"
DOI: 10.1093/ageing/afab242
Abstract: Abstract Background Mobility is defined as the ability to independently move around the environment and is a key contributor to quality of life, especially in older age. The aim of this study was to evaluate… read more here.
Keywords: medicines agency; european medicines; mobility; authorisation drugs ... See more keywords
Old drug, new clinical use, no man’s land for the indication: an awareness call from European experts
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DOI: 10.1136/esmoopen-2019-000615
Abstract: Licence holders of a new medical agent who apply for marketing authorisation in Europe have two choices: They may either apply to a national health authority (which limits authorisation to the authority’s country) or choose… read more here.
Keywords: authorisation; recommendation; marketing authorisation; drug ... See more keywords
The Conditional Marketing Authorisation of Covid-19 Vaccines: A Critical Assessment under EU Law.
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DOI: 10.1163/15718093-bja10065
Abstract: The decision of the EU Commission, based on positive advice from the European Medicines Agency, to grant conditional marketing authorisation to Covid-19 vaccines should be qualified as a precautionary measure. Under the established case law… read more here.
Keywords: marketing authorisation; covid vaccines; law; conditional marketing ... See more keywords
Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities
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DOI: 10.3389/fmed.2021.726660
Abstract: Background: The aim of the study was to identify, interpret, and compare the current perspectives of regulatory agencies in six member countries of BRICS-TM (Brazil, Russia, India, China, South Africa, Turkey, and Mexico) on the… read more here.
Keywords: member countries; regulatory agencies; biosimilar development; marketing authorisation ... See more keywords
Experiences and Perspectives of Marketing Authorisation Holders towards Medication Safety Monitoring during Pregnancy: A Pan-European Qualitative Analysis
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DOI: 10.3390/ijerph19074248
Abstract: Although marketing authorisation holders (MAHs) are involved in monitoring medication safety, it was unclear how they experience their role and current monitoring activities in pregnancy. Therefore, a qualitative study using online focus groups with MAHs… read more here.
Keywords: medication safety; authorisation holders; marketing authorisation;