Inter-Agency Co-operation on the Rise

摘要

On 2 February 2007, the European Medicines Agency (EMEA), the European Commission, the Japanese Ministry of Health, Labour and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency entered an agreement on the sharing of information about the authorisation and safety of medicines. The agreement, signed at a bilateral meeting in Tokyo, is intended to facilitate the exchange of confidential information on issues such as the safety of medicines. In addition, the signatories expect that it will assist in tackling technical barriers to trade and help prevent new barriers arising. The new agreement builds on informal collaboration that has been taking place for many years and was hinted at by EMEA executive director Thomas Lonngren at the EuroDIA meeting in Paris last year. The types of information covered by the agreement include advance drafts of legislation and regulatory guidance documents; scientific advice on product development provided to companies to promote innovation; assessments of applications for marketing authorisations; and information about the safety of marketed medicines.