Swissmedic kicks off pharmacovigilance database modernization plans
This article was originally published in SRA
Switzerland’s healthcare product regulator, Swissmedic, is planning to replace the pharmacovigilance database it currently uses with a modern system by the end of 2017 and has issued a request for information on the project from software suppliers1.
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Switzerland is on track with plans to adopt a new modernized pharmacovigilance system with enhanced data analysis capabilities. The new system will not result in any changes to how companies and healthcare professionals report adverse drug reactions to Swissmedic.
The UK’s current oversight of pharmacovigilance systems is dependent on its access to several databases and centralized systems designed to serve the single EU market. If the UK cannot have continued access to these systems post Brexit, companies may face duplicative requirements and greater workload.
Oral explanation meetings are due to take place this week for drug sponsors who have a final chance to address questions and concerns the European Medicines Agency has about their marketing applications.