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Regulatory Focus™ > News Articles > 2020 > 12 > ICH updates focus on patient-focused drug development, nitrosamines

ICH updates focus on patient-focused drug development, nitrosamines

Posted 11 December 2020 | By Nick Paul Taylor 

ICH updates focus on patient-focused drug development, nitrosamines

The International Council for Harmonisation (ICH) has shared an update on its initiatives, revealing recent progress in areas including its position on elemental impurities and the role patients can play in drug development.
ICH met virtually last month in lieu of a face-to-face gathering that was to take place in Greece. At the event, ICH’s second virtual gathering of 2020, the management committee re-elected FDA’s Theresa Mullin for another one-year term as management committee chair. The committee also discussed the progress of 33 active working groups, several of which have passed key milestones since its previous meeting.
The working group handling an update to the User Guide of EDQM terminologies for Dose Forms and Routes of Administration for Individual Case Safety Reports in the E2B(R3) message reached step 4 in the formal ICH procedure, which covers the adoption of a harmonized guideline. The next step in the process is the implementation of the guideline.
Several other working groups reached an earlier milestone, specifically the second step that covers consensus on the technical document and adoption of a draft guideline by regulatory members.
The working group focused on the ICH Q3D(R2) Guideline for Elemental Impurities reached that point. ICH said the group is addressing amendments to the permitted daily exposure for gold, silver and nickel and limits for elemental impurities by cutaneous and transcutaneous routes.
A working group covering the ICH E14/S7B Question & Answer document on Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential also reached step 2. As ICH noted, the progress was accompanied by a public webinar that addressed the rationale behind the decision to provide an interconnected Q&A for the ICH E14 and S7B guidelines.
The other working group to reach step 2 is handling the ICH M7 Question & Answer document on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. ICH is working on the topic in the belief there is value in the further harmonization of the regulation of mutagenic impurities in pharmaceuticals.
ICH shared details of the progress of its working groups alongside news that it is planning to run a new implementation survey, having last asked a third party to evaluate the level of implementation and adherence to guidelines in 2019; the group also provided an update on training activities. Notable training updates included the publication of an Introductory overview video on ICH Q1 Stability Guidelines. ICH plans to continue engaging with training organizations to support its industry and regulatory members.
Attendees at the virtual event also backed the progress of a new reflection paper on patient-focused drug development that is now out for consultation. The document details areas of drug development that could benefit from the perspective of patients. ICH sees opportunities to improve the quality, relevance, safety and efficiency of drug development and inform regulatory decisions by giving more of a voice to patients.
The reflection paper covers patient-focused questions that ICH thinks are worth asking throughout discovery and development, such as what endpoint is most relevant to people with a condition and what constitutes a meaningful change over time. ICH said the non-exhaustive list is intended to show the range of opportunities to inform development and decision making.
Elsewhere in the reflection paper, ICH describes what it may do to support patient-focused drug development in the future. Potential ICH activities include the development of new guidelines on what to measure in clinical trials and the assessment of patient preferences. ICH is accepting feedback on the reflection paper until 7 March 2021.
The timeline positions ICH to discuss the outcome of the consultation at its next meeting. ICH plans to meet virtually on 2 June 2021. With the period of pandemic-enforced virtual meetings falling on ICH’s 30th anniversary, the organization has put plans for a commemorative conference on hold. Instead, ICH is working on a publication to celebrate the milestone that it plans to release next year.
ICH update
Reflection paper


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Tags: EU, ICH

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