Better EU Electronic Application Forms Become Mandatory In March
A large number of defects have been fixed in the electronic application forms that drug makers must use when applying for marketing authorizations, renewals and variations.
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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include five new products, including Lumoxiti, AstraZeneca's drug for hairy cell leukemia. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
Health technology assessment body NICE has now recommended that selective internal radiation therapy can be used on England’s National Health Service for treating advanced liver cancer.