ICH Wraps Up Organizational Changes To Deliver On Global Initiative Promise
Executive Summary
Iran is the latest country to join the ICH as a regulatory observer. The ICH now has 16 members and 28 observers.
The International Council for Harmonisation has finished implementing all the organizational changes it initiated to support the reform process introduced three years ago and is now focusing on understanding how well the ICH guidelines are being implemented by various regulatory member and observer countries/regions.
At the ICH's latest meeting in Charlotte, North Carolina, US, in November, Iran was appointed as the newest regulatory observer to the standards setting initiative, which now has 16 members and 28 observers.
The addition of the new members and observers has been made possible following structural reforms initiated by the ICH in its attempt to become what it calls "a truly global initiative." The council believes the global orientation of its harmonization efforts is well evidenced in its 25 working groups, which currently involve over 600 experts.
After expanding its membership, the ICH is now focusing on the uptake of its guidelines by members old and new. At the Charlotte meeting, the ICH Assembly made progress on its ongoing project on this topic and supported new terminology to help draw up consistent definitions of the degrees of implementation of ICH guidelines. (Also see "ICH Evaluates Guideline Uptake By New And Old Members " - Pink Sheet, 13 Aug, 2018.)
An ongoing survey, being conducted by an independent third party on behalf of the ICH to map the implementation of ICH guidelines by its regulatory members and observers, is due for completion by the middle of 2019, with outcomes to be published in the second half of 2019.
At the meeting, the ICH also made progress on new and existing guidelines, such as approval of concept papers and business plans in relation to:
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- Analytical Procedure Development and Revision of Q2(R1) Analytical Validation (Q2(R2)/Q14).
- Continuous manufacturing (Q13).
- Clinical electronic Structured Harmonised Protocol (‘CeSHarP’) (M11).
- Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation (E14/S7B).
In addition, timelines were established to start work on two new topics shortlisted earlier, namely Adaptive Clinical Trials (E20) and Drug Interaction Studies (M12), which are now expected to get underway in mid-2019.
The Assembly also considered future strategic areas for harmonization. Among other things it:
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- Endorsed a reflection paper on "Further Opportunities for Harmonization of Standards for Generic Drugs."
- Approved the remit of a new informal quality discussion group on "Advancing Pharmaceutical Quality Standards."
- Discussed a potential new topic on “Strategic Approach to International Harmonization of Technical Scientific Requirements for Pharmacoepidemiological Studies Submitted to Regulatory Agencies to Advance More Effective Utilization of Real-World Data”.
- Approved a new maintenance process for the Q4B annexes, which cover pharmacopoeial texts to be considered as interchangeable.
From the editors of Scrip Regulatory Affairs.