Agreement on Mutual Recognition between Japan and EC: Japanese Regulations Table of Contents 1. Introduction 2. Pharmaceutical and Medical Safety Bureau Notification No. 1430 dated December 28, 2001 on the Enforcement of the Agreement on Mutual Recognition between Japan and the European Community 3. Decision No. 2 of the Sub-Committee under the Sectoral Annex on Good Manufacturing Practice for Medicinal Products - Rules of Procedure for the Sub-committee under the Sectoral Annex on Good Manufacturing Practice (GMP) for Medicinal Products 4. Joint Statement of the Sub-Committee under the Sectoral Annex on Good Manufacturing Practice for Medicinal Products 5. Joint Statement of the Second Sub-Committee Meeting, June 30, 2003 6. Agreement on Mutual Recognition between Japan and the European Community Introduction The Agreement on Mutual Recognition between Japan and the European Community was reached in 2001 and formalised in three consecutive steps - signed by the authorised representatives of the both parties on April 4, 2001, approved by the Japanese Diet on June 6, 2001 and adopted by the Council of Ministers of the EU on September 27, 2001. The Agreement came into force on January 1, 2001 as no transitional period was stipulated, but the time until July 1, 2003 has been planned for the preparatory work. The Agreement covers four sectors: telecommunications equipment, electrical products, good laboratory practice (GLP) for chemicals and good manufacturing practice (GMP) for medicinal products, as each of those sectors has a Sectoral Annex involving the documentation, the activities of the Joint Committee of each Sectoral Annex and the affiliated structures. The Sectoral Annex for GMP for medicinal products is the first for Japan in the field of medicinal products and at present is only for medicinal products designated for human use. The documents collected here refer exclusively to the Sectoral Annex for GMP for medicinal products. Pharmaceutical and Medical Safety Bureau Notification on the Enforcement of the Agreement on Mutual Recognition between Japan and the European Community Table of Contents * PMSB Notification No. 1430 dated December 28, 2001 * Summary - in Japanese (omitted) * Agreement on Mutual Recognition between Japan and the European Community - translation in Japanese (omitted) * Agreement on Mutual Recognition between Japan and the European Community 　　　　 PMSB Notification No. 1430 December 28, 2001 To: All Metropolitan and Prefectural Governors From: Director-General Pharmaceutical and Medical Safety Bureau, MHLW Enforcement of the Agreement on Mutual Recognition between Japan and the European Community 　　　The Agreement on Mutual Recognition between Japan and the European Community in four different fields (henceforth "the Agreement") and the part related to the Good Manufacturing Practice for medicinal products (henceforth "the GMP for medicinal products") is attached here. Although the Agreement was formal signed on April 4, 2001, the exchange through the diplomatic channels was completed on November 30, 2001. By this, the Agreement shall come into effect on January 1, 2002. 　　　 　　　For this reason, and regarding the GMP, on which is based the Agreement, it is expected to be executed in a cooperation such as in the preparatory work for the mutual approval, and in the making and exchanging of a list of institutions for GMP conformity assessment in the future. 　　　 　　　Your cooperation in term of the enforcement of this Agreement and further control on its implementation would be appreciated. 　　　 　　　 Contents 1. The Agreement - provided as separate Appendices a) Summary in Japanese (omitted) b) The Agreement - translation in Japanese (omitted) c) The Agreement - in English (provided here) 2. GMP for medicinal products points of concern a) Since the Agreement shall come into force on January 1, 2002, regarding the GMP for medicinal products, the exchange through the diplomatic channels shall be completed within 30 days pursuant to the Article 2, Article 4, Article 5, Article 7 and a Paragraph 2 (a) of Article 10, but not article 6, Article 7, Item b and Article 9 of the Sectoral Annex Document (henceforth "Sectoral Annex Document") as stipulated in the Article 9, Item a) of the Sectoral Annex Document. b) The detail procedure regarding the implementation of the Agreement will be set up by a special Joint Committee in the future as stipulated in the Article 9, Item b) of the Sectoral Annex Document. Appendices Source: Ministry of Health, Labour and Welfare. Translation: JKS LLC Decision No. 2 of the Sub-Committee under the Sectoral Annex on Good Manufacturing Practice for Medicinal Products Source: Ministry of Foreign Affairs, Japan. Rules of Procedure for the Sub-Committee under the Sectoral Annex on Good Manufacturing Practice (GMP) for Medicinal Products 1. Introduction The role of the Sub-committee (SC) for the Sectoral Annex on Good Manufacturing Practices for Medicinal Products (Annex) to the Agreement on Mutual Recognition (MRA) between the European Community (EC) and Japan is, according to paragraph 6 of the Annex, to monitor the activities under both the preparatory and operational phases. In order to ensure the efficient operation of the SC, the description in the Annex is supplemented as follows to explain the SC's responsibilities, composition, and procedures in detail. 2. Responsibilities The responsibilities of the Pharmaceutical SC are as follows: a. To report to and communicate with the Joint Committee; b. To co-ordinate joint activities; c. To monitor progress of the preparatory work of the Annex and the operation of the same; d. To facilitate regulatory collaboration and communications between the Japanese and EC competent authorities; e. To establish a procedure for coordinating equivalence of GMP for specific products or classes of products; f. To discuss and resolve where possible any major problems that occur and to present to the Joint Committee any issue which cannot be resolved; g. To establish and maintain a list of contact points for each Party; and in particular with regard to the preparatory phase, h. To ensure that documentation and other information needed to reconfirm equivalence are communicated to the appropriate bodies; i. To agree detailed alert procedures; j. To reconfirm equivalence of GMP and their implementation; k. To identify products and classes of products falling under the definition of medicinal products under the scope of the Annex; l. To prepare, for adoption by the Joint Committee, the definition of emergency and modalities of visits to manufacturing facilities in such cases; m. To develop procedures to exchange documents and information; n. To prepare the detailed procedures for the implementation of the Annex, which are to be decided by the Joint Committee. 3. Composition of the SC The SC will be composed as follows: a. Each Party shall nominate a representative who shall jointly chair meetings of the SC. Participation in the SC from each Party should be balanced in terms of the size of their respective delegations. b. Participants in the sub-committee meetings shall not include external parties such as representatives of industry, trade associations, or the press. All meeting attendees will be bound by the same confidentiality, conflict of interest and non-disclosure requirements as regulatory authority employees. The Party on whose behalf a person is attending will ensure the attendee is bound by the relevant confidentiality, conflict of interest and non-disclosure requirements. 4. Procedures of Meetings a. Unless otherwise decided, the meetings of the SC shall not be open to the public. b. The SC will meet at least once a year in person, or by teleconference with the agreement of both Parties. If required for the effective functioning of the Annex, and at the request of any one Party, additional meetings will be held. c. The SC will meet four times during the 18 month preparatory phase, unless it decides otherwise. d. The date and exact venue of the prospective meetings will be agreed to by the co-chairs. e. The draft agenda for each meeting will be prepared by the host co-chair and circulated to the participants in advance of the meeting along with the list of participants. f. Co-chairs are to agree the draft agenda. g. Each Party will endeavour to circulate the papers and reports to be tabled at each meeting at least two weeks beforehand. h. The host will prepare and circulate a table of agreed actions within two weeks from the end of each meeting and the draft summary record of each meeting within one month from the end of each meeting. i. Draft summary record and table of agreed actions should be finalised within a further four weeks and agreed to by the co-chairs. j. The SC will hold ad hoc meetings as requested by either Party and as frequently as both Parties agree is necessary to fulfil the obligations of the Annex. k. The Party hosting a meeting shall arrange logistical matters. Meetings convened by teleconferencing shall be arranged by the Co-chair that requested the meeting. l. The followings shall apply with regard to the use of languages: - Written communication between the Co-chairs shall be in English. - The Party hosting a meeting of the SC shall provide interpretation between Japanese and English and bear the cost for this. 5. Adoption of Documents a. The SC will: - Adopt the agenda at each meeting. - Review the table of agreed upon actions from the previous meeting during each meeting. - Adopt all documents to be submitted to the Joint Committee. b. The SC shall adopt documents by consensus. If the Parties have different positions on a topic, a document may describe each Party's views. 6. Reporting Arrangements with Joint Committee The SC will: a. Report in writing on the outcome of the preparatory phase to the Joint Committee. b. Transmit copies of the adopted agendas and summary records of at least its formal annual meetings to the Joint Committee. 7. Communications to External Parties a. Both Parties will agree on a common statement on the status and operation of the Annex, as appropriate, at the end of each meeting. b. This external communication is to be issued as soon as possible after the meeting; each Party will distribute the common statement as it determines is appropriate. Source: Ministry of Foreign Affairs, Japan. Joint Statement of the Sub-Committee under the Sectoral Annex on Good Manufacturing Practice for Medicinal Products First Sub-Committee Meeting, 14 October 2002 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. Source: Ministry of Foreign Affairs, Japan. Joint Statement of the Second Sub-Committee Meeting, June 30, 2003 Tokyo-London, June 30, 2003 Sectoral Annex on Good Manufacturing Practice for Medicinal Products Second Sub-Committee Meeting, June 30, 2003 Joint Common Statement The second meeting of Sub-Committee set up under the Joint Committee of the Agreement on Mutual Recognition between the European Community and Japan took place by video conference on 30 June 2003. Members of the Sub-Committee from both the EU and Japan participated in this meeting via video or audio connection. Both sides reviewed in this Sub-Committee the progress of joint activities and coordination between the two Parties during the preparatory phase to implement the Sectoral Annex on Good Manufacturing Practice (GMP) for Medicinal Products of the Agreement and discussed future work. The first mutual visits to regulatory authorities were carried out in the EU in June 2002 and in Japan in July 2002 respectively and were followed by a second round of mutual visits in March 2003 including observed inspections. The observed inspections were conducted in accordance with a Standard Operating Procedure tentatively agreed at the last Sub-Committee. Both sides shared the same view that some of the preparatory work for implementing this Annex has not yet been completed, recognising that reconfirming carefully the equivalence of GMP requirements between the two Parties is of crucial importance for ensuring quality of medicinal products traded between the two Parties and also the protection of health and safety of the people of the two Parties. Both sides also recognised the necessity to accelerate the advancement of the preparatory work under this Annex in order to start the operational phase of this Annex at the earliest possible date. Both sides expect that the Joint Committee set up by this Agreement will discuss this issue at its next meeting after receipt of a report from the second Sub-Committee meeting. Japan and EU are to continue regular contacts to discuss progress. Further information on the EC- Japan MRA, Sectoral Annex can be found at: http://www.emea.eu.int/ and http://www.mofa.go.jp Agreement on Mutual Recognition between Japan and the European Community Note: The text reproduced here is the version in English, which the Japanese authorities used for the official translation in Japanese. The title of the Agreement translated in Japanese is shown below. The translation, formatting, indexing and hyperlinking of the text are copyrights of the Jouhou Koukai Services LLC Worldwide Copyright (c) 2001-2003 by JKS LLC Reproduction in whole or part without permission is forbidden. www.jouhoukoukai.com Copyright (c) 2001-2003 by JKS LLC - 16 - Copyright (c) 2001-2003 by JKS LLC - 2 - Copyright (c) 2001-2003 by JKS LLC - 69 -