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.
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EU – Japan agreement on information exchange concerning medicines
- McDermott Will & Emery
- Michal Cieplinski
- European Union, Japan
- February 9 2007
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Senior Patent Counsel
Royal DSM NV