Marketing authorization holders in the EU are to be required to strengthen their oversight of pharmacovigilance services subcontracted to third parties and to make more use of the EudraVigilance drug safety database to help improve the evaluation of safety signals, under new proposals from the European Commission.
EU To Tighten Up Some Pharmacovigilance Requirements
Master File & Adverse Event Reporting In The Spotlight
The European Commission is consulting on a range of proposals to overhaul a nine-year-old regulation on drug safety reporting procedures.
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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 weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
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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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South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.