International – 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…