EC - Japan Mutual Recognition Agreement
Sectoral Annex on Good Manufacturing Practice for Medicinal Products

First Sub-Committee Meeting, 14 October 2002
Joint Common Statement

The Joint Committee established under the Agreement on Mutual Recognition between the EC and Japan took the decision to create the Steering Committee for GMP for medicinal products and its terms of reference.

The first meeting of the Sub-Committee took place in Brussels on 14 October 2002. Representatives of the Japanese Ministry of Health Labour and Welfare, Ministry of Foreign Affairs and the Mission to the European Union as well as the European Commission (Directorate General Enterprise, the European Agency for the Evaluation of Medicinal Products and EU Member State regulatory authorities participate in the Sub-Committee. The terms of reference were noted and both sides confirmed to collaborate to monitor the activities under both the preparatory and operational phases. One of the responsibilities of the Sub-Committee is to monitor progress during the 18 months preparatory phase and co-ordinate activities to reconfirm equivalence of GMP. Both sides endeavour to complete the preparatory phase within the 18 months.

A work plan for the preparatory phase was discussed and the schedule of the main activities drawn up.

The Sub-Committee discussed the scope of the MRA and was successful to detail the scope and exclusions of the EC and Japan GMP regulations.

The elements for reconfirming equivalence were discussed and understanding was reached on most points.

Mutual visits to regulatory authorities and observed inspections are part of the activities of the preparatory phase. The first visits to regulatory authorities were carried out in June (EC experts to Japan) and July (Japanese experts to three Member States). Good progress was made on the modalities of observed inspection and a draft procedure was discussed. The next round of visits is targeted from January to March 2003. Observed inspections will be included in these visits.

The both sides are to continue regular contacts to discuss progress.

Further information on the EC - Japan MRA, Sectoral Annex can be found at:
http://www.emea.europa.eu/ and http://www.mofa.go.jp/region/europe/eu/agreement.html