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ICH Advances Guidance, Adds New Members

Posted 25 June 2018 | By Michael Mezher 

ICH Advances Guidance, Adds New Members

After its meeting in Kobe, Japan earlier this month, the International Council for Harmonization (ICH) on Friday announced it has expanded its management committee, added new members and advanced guidance.


During the meeting, the ICH Assembly voted to add five additional members to the organization's Management Committee, including the China Food and Drug Administration (CFDA), Singapore's Health Sciences Authority (HSA), South Korea's Ministry of Food and Drug Safety (MFDS), representing regulators, and the Biotechnology Innovation Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA), representing industry.

ICH also accepted the Taiwan Food and Drug Administration (TFDA) as a new regulatory member and added regulators from Moldova, Malaysia, Armenia and Turkey as new observers.

According to ICH, the new additions bring the organization's total membership to 16 members and 27 observers.


ICH also announced it has adopted five harmonized guidance documents and endorsed two draft guidances for consultation.

The six guidances, which now await national implementation after reaching Step 4 of the ICH process include:
  • Revision of E2B(R3) Electronic Submission of Individual Case Safety Reports - Questions and Answers
  • eCTD v3.2.2 Questions and Answers and Specification Change Request Document v1.31
  • eCTD v4.0 Implementation Package v1.2
  • eCTD v4 Questions and Answers and Specification Change Request Documents v1.2
  • Specification for Submission Formats for CTD v1.2
At the meeting the Assembly also endorsed the M9 Biopharmaceutics Classification System-based Biowaivers document for public consultation and noted that a draft of its Guideline on Elemental Impurities (Q3D(R1)) with revised permitted daily exposure values for cadmium inhalation was endorsed via written procedure in May.

ICH also announced that it plans to tackle five new topics for future guidance, including analytical procedure development, continuous manufacturing, clinical electronic structured harmonized protocol (CeSHarP), adaptive clinical trials and drug interaction studies.

MedDRA Updates

The MedDRA Management Committee also met in Kobe and announced that its M1 Points to Consider (PtC) Working Group has completed the first edition of its companion documents to the ICH M1 guideline, which the committee says will be made available sometime in mid-2018.

The committee also said that the MedDRA Maintenance and Support Services Organization (MSSO) has conducted implementation training with CFDA and MFDS, and that MedDRA training has been provided to industry representatives in Russia and regulators in Latin America.


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