ICH Updates: Management Committee Endorses Updated Process for New Topics

Posted 31 January 2018 | By Zachary Brennan 

ICH Updates: Management Committee Endorses Updated Process for New Topics

The International Council for Harmonisation’s (ICH) management committee (MC) threw its weight behind an updated process for submitting and selecting new topics for harmonization, according to the minutes of the committee’s meeting in Geneva last November, which brought together regulators from the US, EU, China, Brazil, Canada, Japan and elsewhere.

Under the updated process, the MC’s "New Topics Subcommittee" was expected to hold teleconferences with experts between 15 January and 15 February 2018 on new topics, and in March, the new topic proposals will be prioritized with feedback and recommendations made in writing in preparation for the next face-to-face meeting in Kobe, Japan.

"The MC agreed that the March 2018 MC interim meeting would be focused on the New Topic Subcommittee discussion and other Subcommittee discussion as needed and that all MC Members would be represented at the MC interim meeting by at least one Representative," the minutes said.

The Kobe meeting, to be held 2-7 June 2018, is on track for a targeted number of 18 working groups (WGs), the minutes added.

Meanwhile, Theresa Mullin, the US Food and Drug Administration’s director of the Office of Strategic Programs, was unanimously re-elected as MC chair for a one-year term, while Toshiyoshi Tominaga, associate executive director for international programs at Japan’s Pharmaceuticals and Medical Device Agency, was unanimously reelected as vice chair for a one-year term.

Other Updates

In discussion the "Revision on General Considerations for Clinical Trials," the management committee (MC) endorsed the E8(R1) concept paper and business plan and supported the establishment of an E8(R1) expert working group (EWG).

The MC also supported that the M2 EWG, working on "Electronic Standards for the Transfer of Regulatory Information (ESTRI)," would continue its work on the electronic Clinical Trial Application (eCCTS) project "by performing a survey on regional processes for Clinical Trial Submissions and further complete a pre-concept paper including an overview on potential benefits and risks for regulators and industry based on expert input."

For the E17 EWG on multi-regional clinical trials, the MC agreed on the principle of converting the current group to an Implementation Working Group (IWG) for training purposes and tasked the EWG to develop a concept paper for an IWG, "to include a more complete description of the work which would be undertaken, including Q&As, and an outline of the proposed training curriculum for presentation to the MC by early 2018 for approval."

The MC also said it would further consider creating an ad-hoc Quality Discussion Group (DG) as proposed in the draft Quality Reflection Paper.

"The DG would work to review the proposals set forth in the Quality Reflection Paper to prioritize work related to the further development of Quality Guidelines and the revision of existing outdated Quality Guidelines. This new DG would work by email and teleconference and would not meet face-to-face.

The MC also said it supported reflection papers on proposals for future strategic priorities on Model Informed Drug Development (MIDD) and Patient Focused Drug Development (PFDD).

"The draft Reflection Papers should be developed with the aim of being circulated in the February timeframe in order to facilitate discussion at the planned interim MC meeting, and at the meeting in Kobe, Japan in June 2018," the minutes said.

The MC also said it was updated on the comments received on the draft Vaccine Reflection Paper and on the draft Quality Reflection Paper on Advancing Pharmaceutical Quality Standards.

Minutes ICH Management Committee Meeting Geneva, Switzerland 13-16 November 2017

FINAL MINUTES ICH Assembly Geneva, Switzerland 15-16 November 2017

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles