ICH recaps progress made over past year, charts new topics

Regulatory NewsRegulatory News
| 29 November 2021 | By Joanne S. Eglovitch 

The International Council for Harmonisation (ICH) announced that “significant milestones” were reached over the past year, including the adoption of the widely anticipated guideline on general considerations for clinical studies and the release of question-and-answer guidelines related to the electronic Common Technical Document (eCTD).
Other accomplishments ICH cited in a recent summary of a mid-November virtual meeting include the advancement of a guideline on quality risk management (QRM), an addendum on assessing and controlling DNA-reactive (mutagenic) impurities in pharmaceuticals, and continuous manufacturing of drug substances and drug products.
Significant milestones reached

ICH announced the October release of the Step 4 of the ICH E8(R1) guideline on general considerations for clinical studies as a major milestone. The guideline modernizes the design, conduct and reporting of clinical trials by adopting quality by design principles, and culminates a four-year revision process. (RELATED: ICH announces sign-off on good clinical practices guideline, Regulatory Focus 7 October 2021).
Another accomplishment was the release of an ICH M8 guideline on the electronic common technical document (eCTD) v4.0 question and answer (Q&A) document v1.6, and eCTD v3.2.2 Q&A document v1.32. Both were released as Step 4 earlier this month.
In other areas, work is progressing on ICH Q9(R1) on quality risk management (QRM) which reached Step 2 for public consultation in November. The document will revise the original ICH Q9 guidance, which is now 16 years old, having been issued in November 2005.
The forthcoming guidance, which has not yet been published, “is intended to provide important additional guidance on four specific areas: the levels of subjectivity in risk assessments and in QRM outputs; the product availability risks; the lack of understanding as to what constitutes formality in QRM work; and the lack of clarity on risk-based decision-making.”
Another milestone was the release of the Step 2 ICH M7(R2) draft guideline and addendum on assessment and control of mutagenic impurities in pharmaceuticals to limit potential carcinogenic risk in October. The guideline aims to “provide useful information regarding the acceptable limits of known mutagenic impurities/carcinogenic and supporting monographs.” (RELATED:  ICH guideline proposes daily limits for seven mutagenic impurities, Regulatory Focus 8 October 2021).
Lastly, ICH released the Step 2 guidance on continuous manufacturing of drug substances and drug products, ICH Q13, in July. (RELATED:  ICH releases widely anticipated guidance on continuous manufacturing, Regulatory Focus, 27 July 2021)
New topics introduced
In other areas, ICH said it “supported and endorsed” a new topic proposal and outlining general considerations for model-informed drug development (MIDD). The purpose of such modeling is to make drug development more efficient and to reduce unnecessary patient exposure by integrating data from mathematical and statistical models in predicting the effects of the drugs.
At a North American ICH regional meeting earlier this year, a Pfizer executive described some of the principles behind MIDD and said that a guideline would be issued by the year’s end. (RELATED: ICH: MIDD concept paper coming by year’s end, Regulatory Focus 20 May 2021)
Also, an informal working group is developing a concept paper and business plan to revise the quality portion of the eCTD. The work is taking place under the auspices of ICH M4Q(R2), and when finalized, would replace the ICH M4Q(R1) guideline which has been in effect since June 2003.
New member and observers
ICH also reports that Mexico’s Federal Committee for Protection from Sanitary Risks (COFEPRIS) has joined as a new ICH member. In addition, three new ICH regulators joined as observers, including Egypt’s Drug Authority (EDA), the National Agency for Drug and Food Control of Indonesia, and Ukraine’s Ministry of Health’s State Expert Centre (SECMO). This brings the total number of ICH members to 19 members and 35 observers.
Steady uptake in MedDRA subscribers
ICH also reports “steady uptake” in the number of subscribers to the Medical Dictionary for Regulatory Activities (MedDRA), with over 600 new subscribers in 2021, bringing the total number of subscribers to over 7,400 organizations in over 130 countries.
There are also ongoing efforts to support users’ language needs by translating MedDRA into several additional European languages and to begin work on an Arabic translation. In addition, “Russian translation of the Points-to-Consider documents on MedDRA Term Selection and MedDRA Data Retrieval and Presentation have also been recently made available.”
ICH also announced that there is ongoing work to map MedDRA to other terminologies. One Standardized MedDRA Query (SMQ) that maps terms related to sexual dysfunction was included in the MedDRA v. 24.1 September release, and another SMQ for noninfectious myocarditis is under development.
New selection process, and training guides
ICH also announced that the impact of COVID-19 and the delay in developing work on ongoing topics has prompted a new process for selecting topics in 2022. ICH will now “seek topic candidate(s) with high public health impact and in specific areas.” The ICH Assembly will also “seek more efficient [working group] management to progress work on more ICH guidelines.”
The 5-year strategic plan for ICH will have an expanded focus on developing online training materials to augment tailored training, as part of an “expedited approach to address the training needs of ICH Members and Observers.”
The next ICH Assembly meeting will be held 24-25 October 2022.
ICH announcement


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Tags: E8(R1), ICH, MedDRA, MIDD, Q9

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