safety.DB, adverse events management

REGULATIONS

The rules for the electronic registration and exportation of information regarding adverse reactions to pharmaceuticals (ADRs - Adverse Drug Reactions) between European national authorities were determined by the Directive 2000/38/EC of 5/6/2000 and transposed in Italy with Legislative Decree n. 95 of 8/4/2003.

The community Directive strives for a European system of prompt exchange of information on pharmaceutical safety. 
The Legislative Decree n.95 of 2003 (which has completely reviewed the Legislative Decree n. 44 of 1997) aimed at improving the surveillance of adverse reactions by the central and peripheral health authorities, pharmaceutical companies, and health workers with the objective of guaranteeing a more secure use of pharmaceuticals. 
The new law sets out that the Public Health Care Services and the Health Directorates have seven days to notify the producer and the Directorate-General of the Evaluation of Medicinal Products and Pharmacovigilance of the Health Department. The decree sets forth also the possibility of setting up regional centers, in order to improve the awareness in the territory and organize adequate feedback towards all of the workers involved in the organized voluntary notification.

The structure of the system is completed by the creation of a national network of pharmacovigilance for notifying and receiving information on adverse reactions: a telematic tool of communication and information oriented toward all the references of pharmacovigilance of the regions, Public Health Care Services, hospital trusts, Scientific Institutes for Research, Hospitalization & Health Care, and the pharmaceutical industry.

Following the European Directive, EMEA (European Medicinal Evaluation Agency), the European agency appointed for issuing authorizations for the commercialization of pharmaceuticals, in accordance with the Member States and the European Commission, defined the criteria of gathering and transmitting the data.

The European Commission requires the competent authorities and the pharmaceutical companies of the Member States with gathering the data of pharmacovigilance and the respective electronic transmission according to the standard format set by the ICH (International Conference on Harmonisation): E2BM.