EU Pharma Revision Of Hospital Exemptions For ATMPs 'Is Unsatisfactory'
The EU legislative overhaul falls short on dealing with the issue of hospital exemptions for advanced therapies, says the Alliance For Regenerative Medicine.
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Expanding Hospital Exemptions For ATMPs Could Make Europe Less Attractive To Investors
The forthcoming overhaul of the EU pharma legislation should not include an expansion of the hospital exemption provision for advanced therapies, warn industry and regulators.
Brazilian Regulator Extends COVID-19 Measures
Brazil’s medicines regulator is extending COVID-19 era resolutions designed to speed up its evaluation of clinical research in Brazil.
Canada Publishes Real World Evidence Guidance For HTA And Regulatory Decision Making
The new guidance was drawn up through extensive engagement with national and international experts in RWD and RWE, as well as stakeholders in Canada.