The joint pilot for the implementation of the electronic transmission of individual case safety reports between the EMEA, national Competent Authorities and Pharmaceutical Industry: The experience of the first six months

Article type: Research Article

Authors: Brosch, Sabine

Affiliations: European Agency for the Evaluation of Medicinal Products, London, UK

Note: [] Co-ordinator for the Joint Pilot, European Agency for the Evaluation of Medicinal Products (EMEA), 7 Westferry Circus, Canary Wharf, E14 4 HB London, UK. Tel.: +44 20 74 18 8569; Fax.: +44 20 7 418 8668; E-mail: Sabine.Brosch@emea.eudra.org

Abstract: The EMEA, in collaboration with Competent Authorities of Member States and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA), initiated a joint pilot for the electronic transmission of individual case safety reports (ICSRs) in pharmacovigilance at the end of 1999. The rapid and secure exchange of pharmacovigilance information is of utmost importance to guarantee the protection of public health within the European Union (EU). The implementation and testing of the specifications for the electronic exchange of ICSRs in line with the recommendations of the International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the joint pilot plan, adopted by the Committee for Proprietary Medicinal Products (CPMP) in August 1999, is therefore a new challenge in managing pharmacovigilance data more efficiently. The joint pilot objectives, the procedures and the results achieved within the first six months of these pilot activities are presented.

Journal: Pharmaceuticals, Policy and Law, vol. 4, no. 0, pp. 97-106, 2001