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.
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.”
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