Publications
12 results found
Hofer M, Criscuolo P, Shah N, et al., 2022, Regulatory policy and pharmaceutical innovation in the United Kingdom after Brexit: initial insights, Frontiers in Medicine, Vol: 9, ISSN: 2296-858X
Brexit was presented as an opportunity to promote innovation by breaking free from the European Union regulatory framework. Since the beginning of 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) has operated as the independent regulatory agency for the United Kingdom. The MHRA's regulatory activity in 2021 was analyzed and compared to that of other international regulatory bodies. The MHRA remained reliant on EU regulatory decision-making for novel medicines and there were significant regulatory delays for a small number of novel medicines in the UK, the reasons being so far unclear. In addition, the MHRA introduced innovation initiatives, which show early promise for quicker authorization of innovative medicines for cancer and other areas of unmet need. Longer-term observation and analysis is needed to show the full impact of post-Brexit pharmaceutical regulatory policy.
Chinnery PF, Bonnet M, Cave A, et al., 2022, Choosing drugs for UK COVID-19 treatment trials COMMENT, NATURE REVIEWS DRUG DISCOVERY, Vol: 21, Pages: 81-82, ISSN: 1474-1776
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Hofer M, 2019, Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases., Drug discovery today
OConnor DJ, Sheean ME, Hofer MP, et al., 2018, Defining orphan conditions in the context of the European orphan regulation: challenges and evolution., Nature reviews. Drug discovery
Hofer MP, Hedman H, Mavris M, et al., 2017, Marketing authorisation of orphan medicines in Europe from 2000 to 2013., Drug discovery today
Fregonese L, Greene L, Hofer M, et al., 2017, Demonstrating significant benefit of orphan medicines: analysis of 15 years of experience in Europe., Drug discovery today
Sheean ME, Stoyanova-Beninska V, Capovilla G, et al., 2017, Nonclinical data supporting orphan medicinal product designations: lessons from rare neurological conditions., Drug discovery today
Tsigkos S, Hofer MP, Sheean ME, et al., 2017, Establishing rarity in the context of orphan medicinal product designation in the European Union., Drug discovery today
Gonzalez GA, Hofer MP, Syed YA, et al., 2016, Tamoxifen accelerates the repair of demyelinated lesions in the central nervous system., Scientific reports
Hofer MP, Jakobsson C, Zafiropoulos N, et al., 2015, Regulatory watch: Impact of scientific advice from the European Medicines Agency., Nature reviews. Drug discovery
Syed YA, Baer A, Hofer MP, et al., 2013, Inhibition of phosphodiesterase-4 promotes oligodendrocyte precursor cell differentiation and enhances CNS remyelination., EMBO molecular medicine
Syed YA, Hand E, Möbius W, et al., 2011, Inhibition of CNS remyelination by the presence of semaphorin 3A., The Journal of neuroscience : the official journal of the Society for Neuroscience
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