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EU and Japan seek to align GMP

09-Jul-2003

The European Union and Japan have agreed that there is still a lot of work to be done before a system of mutual recognition of Good Manufacturing Practice standards can be put in place.

At the second meeting of a sub-committee set up under the EU/Japan Joint Committee of the Agreement on Mutual Recognition a video conference was held to discuss the progress of joint activities and coordination during the preparatory phase of implementing the Agreement's Sectoral Annex on GMP for Medicinal Products.

Both parties agreed that some preparatory work for implementing this Annex has not yet been completed, given that reconfirming carefully the equivalence of GMP requirements between the EU and Japan is of crucial importance. They also recognized the need to accelerate the advancement of this preparatory work, in order to start the operational phase of the Annex at the earliest possible date.

A deadline of 18 months for completion of this preparatory work was set out at the subcommittee's first meeting, held in October 2002.

The first mutual visits to regulatory authorities were carried out in the EU in June 2002 and in Japan in July 2002, respectively, followed by a second round of visits in March 2003 that included facility inspections.

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