Article originally published in EURALex, issue 192, in March 2008

The European Commission has launched a consultation on proposed amendments to strengthen and rationalise the European Community (EC) pharmacovigilance rules and systems established by Directive 2001/83/EC and Regulation (EC) No 726/2004. Comments were sought from stakeholders by 1 February 2008. Grant Castle and Robin Blaney summarise the key proposals and discuss some of the issues that they raise.

Generally, the Commission’s proposals should be welcomed. They focus on improving patient safety and increasing the transparency of the pharmacovigilance system, while at the same time increasing efficiency and easing the administrative burden on marketing authorisation holders (MAHs). The proposals also give a legal basis to issues that to date have been dealt with only in guidance. This offers all concerned in the pharmacovigilance system greater legal certainty and should make it easier for the relevant authorities to enforce the provisions where necessary.

Read the complete article here