The new pharmacovigilance legislation and impact on observational studies

Year 2013, Volume: 17 Issue: 2, 61 - 64, 07.03.2014

Sinem Gülmez

Abstract

ABSTRACT
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

Keywords

pharmacovigilance legislation, pharmacoepidemiology, observational study, regulations, European DirectiveThe new pharmacovigilance legislation

The new pharmacovigilance legislation and impact on observational studies

Abstract

GİRİŞ: 1235/2010 sayılı yeni tüzük ve 2010/84/EU sayılı yeni farmakovijilans yö nergesi, Avrupa Birliği (AB) Resmi Gazetesi’nde 31 Aralık 2010 tarihinde yayımlandıktan sonra yü rü rlü ğ e girdi. Yeni düzenlemelerle AB, halk sağlığı ve ilaç güvenliliğine daha sıkı bir takip getirmiş oldu

Keywords

ANAHTAR SÖZCÜKLER: Farmakovijilans yönetmeliği, farmakoepidemiyoloji, farmakovijilans, yasal düzenlemeler

References

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