EMEA calls for improved pharmacovigilence

Pharmaceutical manufacturers should hone their monitoring of the effects of a new medicine on patients by focusing on potential risks identified by sophisticated pre- and post-marketing approval analysis, says the European Medicines Agency (EMEA).

It has issued a detailed guideline on conducting such risk assessments, saying: 'Planning of pharmacovigilance might be improved if it were more closely based on product specific issues identified from..data and pharmacological principles'.

Such planning would guide the use of routinely collected health data 'to provide rapid investigation of predicted or emerging safety concerns'.

Considerations for manufacturers highlighted by the guidelines include adverse reactions, potential for medication errors, possible illegal use, the risk of transmitting infections and possible food-drug interactions.

EMEA suggests potential timetables for assessments and suggests models for organising such work, such as cross-sectional, cohort, case-control and other novel studies. There is also advice on minimising the risk posed by new medicines, including pharmacy and prescription controls.

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*http://www.emea.eu.int/pdfs/human/euleg/9626805en.pdf