of the European Medicines Agency is to maintain and develop the pharmacovigilance database consisting of all suspected serious adverse reactions to medicines observed in the European Community; the data processing network and management system is called EudraVigilance and contains separate but similar databases of human and veterinary reactions. The European Medicines Agency requires the individual marketing authorization holders to submit all received adverse reactions in electronic form, except in exceptional circumstances; the reporting obligations of the various stakeholders are defined by EEC legislation, namely Regulation (EC) No 726/2004, and for human medicines, European Union Directive 2001/83/EC as amended and Directive 2001/20/EC. In 2002, Heads of Medicines Agencies agreed on a mandate for an ad hoc Working Group on establishing a European risk management strategy; the Working Group considered the conduct of a high level survey of EU pharmacovigilance resources to promote the utilization of expertise and encourage collaborative working. In conjunction with this oversight, individual countries maintain their distinct regulatory agencies with PV responsibility. For instance, in Spain, PV is regulated by the Agencia Española de Medicamentos y Productos Sanitarios, which can suspend or withdraw the authorization of pharmaceuticals already on-market if the evidence shows that safety (or quality or efficacy) of an agent are unsatisfactory. Rest of Europe, including non-EU The remaining EU and non-EU countries outside the EU5 accrued ~7% of global 2011 pharmaceutical expenditures. Regulation of those outside the EU being managed by specific governmental agencies. For instance, in Switzerland, PV "inspections" for clinical trials of medicinal products are conducted by the Swiss Agency for Therapeutic Products. Japan In Japan, with ~12% of all global 2011 pharmaceutical expenditures, PV matters are regulated by the Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour, and Welfare. Canada In Canada, with ~2% of all global 2006 and 2011 pharmaceutical expenditures, PV is regulated by the Marketed Health Products Directorate of the Health Products and Food Branch. Canada was second, following the United States, in holding the highest total prescription drug expenditures per capita in 2011 at around 750 US dollars per person. Canada also pays such a large amount for pharmaceuticals that it was second, next to Switzerland, for the amount of money spent for a certain amount of prescription drugs (around 130 US dollars). It was also accessed that Canada was one of the top countries that increased its yearly average per capita growth on pharmaceutical