EU and Canada sign drug information exchange agreement
The European Union and Canada have signed an agreement allowing them to exchange confidential information about the authorisation and safety of medicines.
The European Union and Canada have signed an agreement allowing them to exchange confidential information about the authorisation and safety of medicines.
The agreement was signed at a bilateral meeting in Brussels in December. Similar agreements have been signed between EMEA and the US and Japan. EMEA executive director, Thomas Loenngren recently announced that international collaboration would be a priority for the agency in 2008.
The EU and Canada have long worked together on medicines and therapeutic product regulation and a mutual recognition agreement on manufacturing of medicines is in force.
The new confidentiality agreement will "allow exchange of information between the parties as part of their regulatory and scientific processes, both before and after a medicine has been approved".
The agreement applies to documents on future legislation, guidance documents and scientific advice "on product development given to companies to promote innovation". Also involved are assessments of marketing authorisation applications and documents relating to the safety of marketed medicines.
The agreement has been signed for an initial five-year period, after which an evaluation will be made.