News about GMP/cGMP


ICH: Plans to harmonize with PIC/S and WHO

The International Council for Harmonisation (ICH) has made the Minutes of the ICH Assembly Meeting in Singapore, in November 2019, publicly available. In contrast to the already published press release (we reported), the meeting minutes include new details on the following interesting projects for the GMP area:

  • A closer collaboration with PIC/S on guidelines with relevance to both Regulatory Assessor and  Inspector disciplines is being planned.
    PIC/S would be involved in ICH Guideline work during the public consultation following Step 2band 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 supported the development of a pilot process.
  • On her part, the WHO is planning to cooperate with the ICH.
    The Assembly noted WHO’s considerations shared on the areas of work and complementarities of ICH and WHO which should be considered in ICH Guideline development.
  • The Concept Paper outline on the revision of ICH Q9: Quality Risk Management was approved. Both, the ICH Assembly and Management Committee noted capacity constraints in the quality topic area. The starting time for the Q9(R1) guideline will therefore be delayed.
  • The Q3C(R8) Maintenance EWG continues its work on the development of Permitted Daily Exposure (PDE) levels for the solvents 2-methyltetrahydrofuran, cyclopentylmethylether and tert-butanol. Q3C(R8) is expected to reach Steps 1 and 2a/b by early 2020.
  • The Q3D(R2) Maintenance EWG continues its work on the draft Addendum on cutaneous and transdermal routes of administration.Steps 1 and 2a/b of the Q3D(R2) revision for the cutaneous and transdermal products are expected by early 2020.

The next meeting is scheduled from May 23-27, 2020 in Vancouver, Canada.


ICH: Meeting Minutes