Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Strengthening and Rationalising the European Pharmacovigilance System ***

Dr. Andreas Grummann (Abschlußjahr: 2008)

Language: English

According to an independent study conducted in 2004 and 2005 and a public consultation conducted by the European Commission in 2006 the current European pharmacovigilance system is complex, duplicative and actions in response to safety issues are incoherent and slow.

The strategy of the European Commission announced on 26 February2007 aims at strengthening and rationalising the European pharmacovigilance system by improving the implementation of and changing the current legal framework. The proposal for changing the current legal framework was published on 5 December2007, and responses to this legislative proposal were collected within a public consultation open to 1 February2008. The responses were published in April 2008.

The Master Thesis addresses the proposed legislative changes affecting expedited reporting, periodic reporting and referral procedures.

The proposed legislative changes are described, comprising centralised expedited reporting based on simplified reporting rules, centralised periodic reporting providing the legal basis for the existing Member States work-sharing initiative, centralised monitoring of the worldwide scientific literature and the establishment of one single referral procedure exclusively for managing safety issues. Moreover, patient reporting, the European list of medicinal products under intensive monitoring and public hearings are described.

These legislative changes would significantly rationalise the European pharmacovigilance system. However, further possibilities of rationalising and strengthening the European pharmacovigilance system are outlined taking into consideration the responses to the proposal for changing the current legal framework and the US pharmacovigilance system. In this regard, current and proposed requirements on expedited and periodic reporting, public hearings within Advisory Committee meetings and the communication of emerging drug safety information in the US are described.

Pages: 46