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Regulatory Focus™ > News Articles > 2020 > 2 > ICH Plots Closer Collaboration With PIC/S

ICH Plots Closer Collaboration With PIC/S

Posted 11 February 2020 | By Michael Mezher 

ICH Plots Closer Collaboration With PIC/S

In minutes from their meeting in Singapore last November, the International Council for Harmonisation (ICH) Management Committee and Assembly provide updates on a range of issues not covered in previous releases from the meeting, including the potential for closer collaboration with the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) and new topics and reflection papers under development.
PIC/S Collaboration
The ICH Management Committee said it received positive feedback on a proposal for more routine engagement with PIC/S on guidelines relevant to regulatory accessor and inspector disciplines.
The proposal would involve a pilot phase focusing on a few quality guidelines that was expected to be shared with PIC/S last month.
“As part of this proposal and in line with ICH processes, PIC/S would be involved in ICH guideline work during the public consultation following Step 2b and additionally, as an ICH Observer, PIC/S could also request to be part of Plenary Working Parties (PWPs) which would allow an involvement prior to step 1,” the Assembly said, noting that it expects an update on the proposal at the upcoming ICH meeting in Vancouver in May.
Working Groups and Capacity
The ICH Assembly may be concerned the organization is taking on too many topics at once, pointing out that there are 32 ongoing working groups comprised of more than 700 experts from its members and observers.
The Assembly said that “as a general rule ICH aims for 25 ongoing [working groups]” and said there is a need “to balance ICH’s interest in pursuing new topics and ICH’s capacity in terms of the number of [working groups] operating in parallel.”
Both the ICH Assembly and Management Committee noted capacity constraints in the quality topic area.
“To avoid duplication of work, any new topic proposals received on quality topics would be redirected by the [Management Committee] to the Quality Discussion Group (QDG) which would review the topics falling within its remit and report with a recommendation for the 2021 new topic process, including considerations on the expert capacity for Quality related topics.”
The Management Committee also noted that the starting time for the Q9(R1) guideline on quality risk management “would be delayed and further determined by the [committee] at a later point.”
2020 New Topic Process
While the deadline to submit new topics for ICH consideration in 2020 was last December, the ICH Management Committee said it expected to receive at least 10 new topic proposals for 2020, which it plans to review in at its interim meeting in March before sending its assessment to the Assembly in April.
ICH also gave an update on several reflection papers currently in development. According to the Assembly, a revised draft reflection paper on model-informed drug development (MIDD) and an update on a draft reflection paper on patient-focused drug development (PFDD) are expected to be shared at the Vancouver meeting. The ICH Management Committee also notes that the Biotechnology Innovation Organization (BIO) proposed to develop a reflection paper on gene therapy harmonization, though the committee said the topic will be placed on hold for “possibly one year.”
During the meeting, ICH’s Pharmacopeial Discussion Group (PDG) updated the Assembly on the ongoing Q4B maintenance procedure. The Assembly said it expects the PDG to submit 14 Q4B annexes for endorsement at the Vancouver meeting, followed by a proposed revision to the Q4B guideline by the November 2020 meeting in Athens, Greece.
In addition, the ICH Management Committee said it is considering changes to ICH’s funding model, which may include fees for observers and increased fees for members.
The Management Committee said it will launch a call for volunteers to join a Financial Subcommittee to work on the funding model ahead of its interim meeting in March.
Minutes: ICH Assembly, ICH Management Committee


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