EMEA/Health Canada's confidentiality deal

The European Medicines Agency (EMEA), the European Commission and Health Canada have agreed an implementation plan for confidentiality  arrangements. This details the process for both regular and ad hoc  exchanges of information, and describes the process for monitoring the  progress of the implementation plan. It also foresees an exchange  program for staff to promote mutual learning and sharing of regulatory  experience.

The terms of the confidentiality arrangement, signed in December 2007,  allow the parties to share non-public information on all human and  veterinary medicines - already authorized or still under review - that  fall within the scope of the agreement. It also allows the exchange of  data on legislation under development or draft regulatory guidance  documents.