EU Risk Plan Easing For Long-Marketed Products Sought By Industry Groups
EFPIA and AESGP are set to submit a joint proposal to the EMA that would streamline risk management plans for long-marketed products and provide uniform treatment for products approved under differing regulatory procedures.
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Fees set to be introduced to cover the cost of the European Medicines Agency’s part in improving drug safety could impose a huge burden on the EU pharmaceutical industry and lead to the closure of smaller firms, the industry says.
Even as a proposal to improve the European Union pharmacovigilance system for marketed drugs moves one step closer to adoption, industry is increasingly concerned about its cost and complexity.
The development of good vigilance practices will be the focus of both European Union and International Conference on Harmonization working groups