We read with interest the letter by Torbjorn Callreus regarding our recent review article on the new EU legislation on pharmacovigilance. Our purpose was to provide an up-to-date, comprehensive review of the complex legislative framework on EU pharmacovigilance and how this is going to change once the new legislation is fully implemented in the EU by Member States, the Commission and the European Medicines Agency. We believe our review will help all stakeholders (regulators and industry) understand the new issues when confronted with the complex legislative changes and their ramifications on current practices.
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