The European Parliament has revised its pharmacovigilance legislation to improve the early detection of rogue side effects and enhance patient safety.
The updated legislation will more clearly define the roles for the key parties responsible for monitoring medicine that is entered into the market, in hope of improving transparency.
All new or updated drugs will also come with specific warnings for still undetected side-effects.
European Federation of Pharmaceutical Industries and Associations (EFPIA) director general Brian Ager welcomed the plans: “EFPIA has consistently been supportive of these efforts to strengthen and rationalise EU’s pharmacovigilance system.
“While some of the provisions raise concerns, and will require carefully considered implementing measures be adopted in order to deliver the stated objectives of the legislation, on balance it is a positive move. EFPIA is fully committed to helping implement the new legislation.”
A pharmacovigilance risk assessment committee will be created within the European Medicines Agency as part of the new law.
In addition, EudraVigilance – the community pharmacovigilance database – will be further developed, and measures will be put in place to allow patients to directly report any suspected adverse reactions to medicinal products.
The pharmacovigilance directive has already been agreed by the Council of Ministers and the European Parliament’s Public Health Committee.