A year ago the new legislation came into force Pharmacovigilance thanks to which the legal framework for the surveillance of medicinal products has been substantially modified, with rules aimed at strengthening the possibilities of identifying the "signal" and making the procedure that must be implemented to deal with all the drug safety issues.
"The European breath of Pharmacovigilance, although already present in previous regulations, is increasingly accentuated - explains Giuseppe Pimpinella, Director of the Office Pharmacovigilance of AIFA – The new directive is in fact focused on the sharing of tasks between the various Authorities: while before the sharing of activities was almost an optional exercise, more like a simple exchange of views, now the division of tasks is a true regulatory requirement is exactly".
The new European Directive on pharmacovigilance (DE 2010/84/EC) introduced many important changes. More transparency, reporting directly from citizens and broadening the definition of adverse reaction, including those from therapeutic error and drug abuse.
“The general strategic objectives of the new legislation – underlined Dr. Pimpinella – tend to ensure the greatest transparency, speed and effectiveness of the circulation of information on suspected adverse drug reactions (ADRs) and to better establish each role”.
One of the main points is the enhancement of the "shared work": the evaluation carried out by each Member State is made available to all the others. Currently, for example, each Member State is entrusted with the safety assessments of different molecules, to then share the final results.
“Now the Member States have divided the medicinal specialties by
