The Pharmaceutical Journal
Vol 276 No 7385 p99
28 January 2006

This article
Reprint   Photocopy

  Acrobat Reader

News summary

Pharmacovigilance guideline

European pharmacovigilance guidelines for human medicines are being updated to take account of international harmonisation and scientific and technical changes.

Under the plans, pharmaceutical companies will need to have a “qualified person” for pharmacovigilance in the same way as they currently need QPs responsible for clinical trials and product quality. New pharmacovigilance reporting requirements are also to be introduced, as are rules for submitting periodic safety update reports and the electronic transmission of individual case safety reports to licensing authorities.

The new proposals form part of a document that will constitute the EU’s rules on human medicines. Public consultation on the current form runs until 17 March.