EC - Japan MRA
The text of the MRA with Japan was adopted 27 September 2001 by the Council of Ministers and is published in the Official Journal L284 on 29 October. The date of entry into force and hence the commencement of the 18 month preparatory work is 1 January 2002. Mutual visits to exchange information and discuss key elements of the preparatory work took place in June and July 2002. Further rounds of mutual visits took place in 2003 and early 2004. Observed inspections were included in these visits. The MRA applies to human medicinal products only.
The subcommittee monitoring the progress of the preparatory work and coordinating joint activities of both EU and Japan met for the third time on 18 - 19 February 2004. A Joint Common Statement is available from this meeting.
The EC and Japan have exchanged diplomatic notes on 28 April 2004 confirming the completion of the preparatory work under the Sectoral Annex on GMP. The GMP Annex became operational on 29 May 2004 in accordance with its relevant provisions. Guidance on product coverage and other operational details will be developed.
The scope of medicinal products subject to the GMP Annex, based on the results of the preparatory work conducted jointly by the two Parties, is described below:
- Chemical pharmaceuticals are covered by the GMP Annex.
- Homeopathic medicinal products are covered by the GMP Annex as long as they are treated as drugs and subject to GMP requirements in Japan.
- Vitamins, minerals and herbal medicines are covered by the GMP Annex if they are considered as medicinal products in the both Parties.
- Medicinal gases, in-vitro diagnostics, blood, plasma and any unstable medicinal products derived from human blood or plasma are not covered as they are not treated as medicinal products or not subject to GMP requirements in the Parties.
- Biological pharmaceuticals, including immunologicals and stable medicinal products derived from human blood or plasma, and sterile medicinal products are currently not covered by the GMP Annex as the equivalence of their GMP requirements has not been reconfirmed, but may be covered in the future.
- Medicinal products for clinical trials and active pharmaceutical ingredients are currently not covered by the GMP Annex, but may be covered in the future.
Documents of interest:
- Utilisation of EudraGMDP database in regulatory procedures in the context of the mutual recognition agreement (MRA) between Japan and the EU - impact on good manufacturing practice (GMP) certificates, September 2013
- Second Sub-Committee Meeting, Joint Common Statement, June 2003
- Third Sub-Committee Meeting, Joint Common Statement, February 2004
- Fourth Sub-Committee Meeting, Joint Common Statement, October 2006
- Fifth Sub-Committee Meeting, Joint Common Statement, April 2014
- Diplomatic Notes exchanged on completion of the preparatory work 28 April 2004: EC and Japan
- Text of the EC – Japan MRA
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