Electronic Exchange

The BPI represents approximately 280 pharmaceutical firms, including both small and medium-sized national enterprises and multinational companies. These include not only the classic pharmaceutical firms, but also biotechnology and medical device companies and service-providers, all of whom use the BPI as a political and communication platform to develop collaborative responses to the diverse challenges they face.

It is the goal of the German regulatory authorities to have all pharmaceutical firms in Germany participating in the electronic exchange of safety messages in the year 2007. The exemption from this regulatory requirement will only be granted to a small number of firms. As a result, a large number of firms with very few safety reports per annum will be suddenly confronted with the previously unnecessary effort and expense of installing an electronic reporting system in-house or using the EVWEB tool of the EudraVigilance database. To facilitate the participation of as many firms as possible in the EudraVigilance Community, the BPI-Pharmacovigilance database project, dubbed ‘BPIPheda’, was conceived as an affordable and user-friendly solution to be offered to interested firms.

LEGAL CONTEXT

In December 2001, the European Medicines Agency (EMEA) launched the EudraVigilance system – the European database that stores all the individual case safety reports (ICSRs) reported for marketed products and, subsequently, all suspected unexpected serious adverse reaction (SUSAR) reports from clinical trials filed by the national competent agencies and pharmaceutical companies. The reporting obligations of the parties involved are defined in the community legislation, in particular Regulation (EC) No 726/2004, Directive 2001/83/EC, as amended, and Directive 2001/20/EC.