The European Medicines Agency has published keenly-awaited revised EU guidance on what measures drug companies can employ to prevent or minimize the risks associated with their products, along with a revised addendum on how to gauge the effectiveness of such measures.
EMA Overhauls Guidance On Risk Minimization Activities
Drug companies may have to adjust their benefit-risk management strategies to ensure compliance with the European Medicines Agency’s newly revised guidance on how to develop and evaluate risk minimization measures.
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Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
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Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
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The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.
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South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.