Brexit: New Deadlines Kick In For Industry And ‘Reassigned’ Rapporteurs
The European Medicines Agency has announced the post-authorization procedures that the newly reassigned (co-)rapporteurs must start handling as of this month.
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The EMA is to further refocus on its core activities to help it deal with “higher than expected” staff losses due to its relocation to Amsterdam.
The Pink Sheet’s list of EU centralized approvals of new active substances has been updated to include a new product – Alnylam Pharmaceuticals' Givlaari for treating acute hepatic porphyria. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).
The health technology assessment institute is taking a virtual approach to meetings and has said that it can provide free fast-track advice for companies developing novel diagnostics or therapeutics for the coronavirus.