European Parliament Revises Pharmacovigilance Law

The European Parliament has revised its pharmacovigilance legislation to improve the early detection of rogue side effects and enhance patient safety.

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."

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