After lengthy discussions, the European Union and Japan have reached an agreement on the exchange of confidential information about the authorisation and safety of medicines. The new confidentiality arrangements will allow the transfer of advance drafts of legislation, scientific advice on product development and, most importantly, transfer of detailed assessments of applications for marketing authorisations. As a result, producers of pharmaceuticals filing for marketing authorisations either in Europe or Japan should be aware that the information they provide will be transferred to the relevant authority in the other country. Pharmaceutical companies should therefore take into consideration rules concerning marketing authorisation in both jurisdictions, as the release of certain information to one authority may affect their application in the other jurisdiction.
Register Now As you are not an existing subscriber please register for your free daily legal newsfeed service.Register
If you have any questions about the service please contact firstname.lastname@example.org or call Lexology Customer Services on +44 20 7234 0606.
EU – Japan agreement on information exchange concerning medicines
- McDermott Will & Emery
- Michal Cieplinski
- European Union, Japan
- February 9 2007
If you are interested in submitting an article to Lexology, please contact Andrew Teague at email@example.com.
"I would like to thank the SCCA for this excellent service! The articles included in the newsfeeds are very useful and informative, and the user-friendly format of the newsfeeds means I can quickly glance over the précis in...
"I would like to thank the SCCA for this excellent service! The articles included in the newsfeeds are very useful and informative, and the user-friendly format of the newsfeeds means I can quickly glance over the précis in the emails to choose what to zoom in on."
Shell Eastern Petroleum