EMA clarifies how to collect data from non-interventional post-authorization studies
This article was originally published in SRA
The European Medicines Agency has issued new requirements on how drug companies should manage and report adverse reactions from non-interventional post-authorization safety studies. The requirements, which are outlined in a revised EMA guideline on good pharmacovigilance practices (module VI)1, will become mandatory for any new study started after January 2015.
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