The European Union and Japan have entered into confidentiality arrangements relating to the exchange of information on the authorisation and safety of medicines pre and postregulatory approval. The European Commission and the European Medicines Agency (“EMEA”) on one side and the Japanese Ministry of Health, Labour and Welfare (“MHLW”) and the Japanese Pharmaceuticals and Medical Devices Agency (“PMDA”) on the other, concluded the agreements during their bilateral meeting of 2 February 2007 in Tokyo.
The confidentiality arrangements cover human medicines subject to evaluation or authorised under the centralised authorisation procedure as well as medicinal products authorised at national level by the EU Member States that are subject to official EU arbitration and referrals.
The type of information covered by the confidentiality arrangements includes:
(i)advance drafts of legislation and/or regulatory guidance documents,
(ii) information contained in applications for scientific advice, orphan medicine designation, marketing authorisation or postauthorisation activities of significant public health interest and applications for agreement of paediatric investigation plans
(iii)post-authorisation pharmacovigilence data, particularly those of an urgent nature related to adverse drug reactions as well as safety concerns arising from periodic safety update reports and post-authorisation obligations and commitments.
(iv)Good Clinical Practices (“GCP”) inspections for specific products and GCP Inspection reports available to the EMEA or the European Commission.
(v) Information Technology systems supporting regulatory processes.
The potential benefit of this exchange of information includes the accelerated access of patients to new medicines, resource savings due to reduced duplication of assessment and improved performance and safety as a result of the involvement of the best regulatory expertise from both sides.