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 authorised or still under review - that fall within the scope of the agreement. It also allows the exchange of information on legislation under development or draft regulatory guidance documents.
In the initial implementation phase, emphasis will be given to exchange of information on medicines used in oncology and on veterinary medicines. The implementation plan with Health Canada follows largely the plan in place for implementation of the confidentiality arrangements with the United States Food and Drug Administration (FDA). The regulatory agencies will explore potential joint implementation activities with the FDA to avoid duplication of efforts.
- The implementation plan can be found here: http://www.emea.europa.eu/pdfs/general/direct/internationalcoop/implementation_plan-en.pdf
- More information on the international work of the European Medicines Agency can be found here: http://www.emea.europa.eu/htms/general/direct/internationcoop.htm