Editor-in-Chief İlkay Küçükgüzel Associate Editor Esra Tatar Online ISSN 2630-6344 Publisher Marmara University Frequency Quarterly (January-April-July-October) Abbreviation J.Res.Pharm. Former Name Marmara Pharmaceutical Journal
Journal of Research in Pharmacy 2013 , Vol 17 , Issue 2
The new pharmacovigilance legislation and impact on observational studies
Sinem Ezgi Gülmez
Université Bordeaux Segalen, Pharmacologie, Bordeaux, Fransa DOI : 10.12991/201317374 BACKGROUND: After the publication of the Regulation (EU) No 1235/2010 and Directive 2010/84/EU on 31st of December 2010, the new legislation on pharmacovigilance came into operation for the better protection of public health through a further strengthened EU system for medicines safety.

REMARKS: The main changes include the new definition of adverse reactions, Eudravigilance becoming the single receipt point for all pharmacovigilance information through the EU, the Pharmacovigilance Risk Assessment Committee, and strengthened PASS/PAES, and requirement of a risk management planning for all new medicines. The possible increase in PA(E)SS may be a concern in terms of access to appropriate data and so obtaining necessary authorisations without delays.

CONCLUSION: The new legislation will provide good vigilance practice standards with increased transparency of pharmacovigilance data. The communication will improve with the involvement of patient and public. With better access to real-life data, better protection of public health will be ensured. Keywords : pharmacovigilance legislation, pharmacoepidemiology, observational study, regulations, European Directive

Marmara University