The European Commission's Directorate-General Enterprise and Industry, the European Medicines Agency (EMEA), and the Health Products and Food Branch of Health Canada have recently concluded confidentiality agreements which will allow the following types of information to be shared between these authorities, in the area of medicines and therapeutic product regulation:

  • Position papers on future legislation and/or regulatory guidance documents;
  • Scientific advice on product development given to companies to promote innovation; assessments of applications for marketing authorizations;
  • and information about the safety of marketed medicines to better protect public health.

The recognized benefits of these agreements will provide accelerated access to information and thus make it easier and quicker to protect public health and improve performance and safety.

For the full article, please see:  http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/int/announce_hc-ec-emea-sc_annonce_e.html