EMA To Clarify Member State-Specific Requirements For New EudraVigilance System
Drug makers preparing for the launch of the enhanced EudraVigilance database in the EU will soon be told about any plans, arrangements and requirements that are specific to the national competent authorities.
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The European Medicines Agency will use a phased approach to help companies comply with their obligation to monitor the revamped EU pharmacovigilance database and to report validated signals. Under a pilot to be launched on Feb. 22, 2018, companies will only have to monitor and report signals on drugs under additional monitoring.
The Italian regulatory body AIFA has announced a new system allowing the public and health professionals access to information held on the national database of adverse drug reactions. The database can be searched by brand name or active ingredient.
Some regulatory activities have been on hold at the European Medicines Agency as it prepares for the impact of the UK’s departure from the EU. The EMA is also concerned that unexpectedly high staff losses will seriously affect its ability to operate.