Topics ICH Association 9th Meeting "ICH Singapore Meeting" was held

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The face-to-face meeting of the International Conference on Harmonization of Pharmaceutical Regulations (ICH) Association was held in Singapore from November 16-20, 2019. The meeting included an Expert Working Group (EWG) to discuss technical guidelines, a Management Committee responsible for preparing proposals to be presented and discussed at the General Assembly and for the management of the ICH, and a General Assembly attended by all members. The meeting was attended by more than 450 participants from a total of 48 organizations, including ICH member regulators, industry associations, and observers. The ICH face-to-face meetings are held on a rotating basis among the three regions of Europe, the United States, and Asia. In the past, all Asian meetings have been held in Japan, but this was the first time for the meeting to be held outside of Japan.

ICH Singapore Meeting (General Assembly)

The participating organizations at the ICH Singapore Meeting included six industry-government organizations*1 from Japan, the U.S., and the EU, which are founding members, two permanent members (Health Canada and Swissmedic), eight member organizations*2, two permanent observers*3, and 30 other observers. Thirty-eight members from the Pharmaceutical Manufacturers Association participated. Fourteen Topics were discussed in person this time, including six Topics that were being discussed for the first time in a face-to-face meeting.

The EWG discussions took place over five days (four days for some Topics) from November 16 to 20. In parallel, the Management Committee met on November 17 and 18, and the General Assembly, the decision-making body, met on November 19 and 20, and some Topics were approved for Step transition.

Below are some special notes from the Singapore meeting.

1. approval of newly elected Trustee members

The Brazilian regulatory authority (ANVISA) was approved as a newly elected Trustee member.

The ICH Management Committee consists of eight permanent members (regulators and industry associations from Japan, the U.S. and Europe, respectively, and regulators from Switzerland and Canada), up to six elected members (four regulators and two industry associations: elected periodically), and WHO and IFPMA as permanent observers.

Currently, there are only three elected member regulatory organizations, NMPA (China), HSA (Singapore), and MFDS (Korea), leaving one vacancy, which will be filled by the Brazilian regulatory authority. The industry association slate of elected member organizations is currently occupied by BIO and IGBA.

The requirements for running as a regulatory authority for membership on the elected management committee are: "Participation in ICH face-to-face meetings for four consecutive years," "Dispatch of experts on two or more Topics," and "Implementation of ICH guidelines (at least up to Tier 2*4).

2. election of the Chair and Vice-Chair of the General Assembly and Trustees

The Chair and Vice-Chair of the General Assembly and the Chair and Vice-Chair of the Management Committee are elected for two-year and one-year terms, respectively, during the ICH face-to-face meetings. Mr. Nobumasa Nakajima, Councilor of PMDA, was re-elected as Vice-Chair of the Management Committee. The situation will continue to allow Japan's presence to be demonstrated.

Assembly

MC

3) Trends in the Technical Topic

All 14 Topics discussed during the face-to-face meeting are as follows: Q12 (in bold) was approved to move to Step 4. Q12 (in bold) has been approved to move to Step 4 and will be implemented by each regulator in the future. The underlined 6 Topics were discussed for the first time in the face-to-face meeting, and the Concept Paper and Business Plan were finalized for all of them.

The following two other Topics were not discussed in-person, but were approved to move to Step 4. As with Q12 above, we will wait for implementation by the respective regulatory authorities.

The following 3 Topic are those that were agreed upon for future progress. They will be promoted as new Topic in the future, although there are differences in timing.

4. review the results of the survey on the implementation of the guidelines in the ICH region

A survey on the implementation of the ICH Guidelines was conducted from February to April 2019 and the results were published on the ICH website in November. At this meeting, we discussed the results of the survey, the scope of future survey items, etc.

The following guidelines were reviewed for implementation in this survey.

5. training

Mr. Masashi Yokota, Vice Chairperson of the ICH Project Committee of the Pharmaceutical Association of Japan, has been appointed as Co-Lead of the Training Subcommittee, which will comprehensively manage activities to ensure efficient implementation of the ICH guidelines in each region by supporting the implementation of various external training programs on the ICH guidelines and the development of an online training delivery system. The committee will comprehensively manage activities to promote the implementation of the ICH Guidelines in each region in a reliable and efficient manner.

6. ICH 30th Anniversary

Thirty years have passed since the inception of ICH, and we will celebrate the 30th anniversary with a face-to-face meeting in Athens, Greece, in the fall of 2020. In addition, special ICH sessions will be held at the Drug Information Association (DIA) EURO Annual Meeting in March 2020, the DIA USA Annual Meeting in June 2020, and the DIA Japan Annual Meeting in November 2020, respectively.

At this meeting, videotaped interviews were conducted with key participants of the in-person meetings in preparation for the 30th anniversary celebration. Camera crews also entered each Topic and Assembly meeting room to record the meeting. A documentary-style video will be made for the Athens meeting. Please keep an eye on ICH Activity, including sessions at the DIA Annual Meetings in Japan, USA, and Europe (Brussels, Belgium in March, Washington, USA in June, and Japan in November).

Upcoming ICH Assembly Meetings

May 23-27, 2020 Vancouver, Canada

ICH is actively disclosing information on ICH activities, including the outcomes of ICH meetings, to deepen understanding of ICH activities not only among those involved but also among the general public. The outcomes of this ICH Singapore meeting, concept papers on each topic, work plans, etc. are available on the ICH website ICH website.

( Manabu Yanagisawa, Director, International Regulatory Coordination Division)

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