ICH reports “significant milestones” reached on guidelines ranging from impurity testing to eCTD standards

Regulatory NewsRegulatory News | 14 June 2021 |  By 

The International Council for Harmonisation (ICH) has reported that “significant milestones” were reached over the past year in the adoption of guidelines on residual solvent testing, carcinogenicity testing, and specifications for submitting applications in the electronic Common Technical Document (eCTD).
ICH made this 10 June announcement following a virtual meeting of the ICH Assembly. During the meeting, the ICH Assembly adopted several guidelines for Step 4 of the ICH process, while revising existing guidelines.
ICH noted that these milestone guidelines over the past year include the Step 4 sign-off of the Q3C(R8) guideline on residual solvents, which has been revised to include the permitted daily exposure (PDE) levels for 2-methyltetrahydrofuran, cyclopentyl methyl ether and tertiary butyl alcohol. (RELATED: ICH announces sign-off of residual solvent guideline, Regulatory Focus 3 May 2021).
Also reaching Step 4 was the ICH M8 guideline on the eCTD v.4 question and answer document (Q&A) document v.1.5, specifications for submission format for eCTD v. 1.3, and eCTD v.4.0 implementation package v.1.4.
Another milestone guideline was the draft ICH S1B(R1) Addendum to the Guideline on Testing for Carcinogenicity of Pharmaceuticals, which reached Step 2 for public consultation. ICH announced that it plans to finalize a Step 4 document by May 2022. (RELATED: To speed drug development, ICH proposes reducing rat carcinogenicity testing, Regulatory Focus, 14 May 2021).
Still another was the draft ICH S12 Guideline on Nonclinical Biodistribution Considerations for Gene Therapy Products, which reached Step 2 for public consultation.
ICH also made “significant progress” on revising the ICH E6 guideline on good clinical practice, with the recent publication of a draft principles guidance, which was presented at two global public web conferences in May 2021. “ICH hopes that sharing the draft version of the principles will facilitate transparency and better understanding on the revision of this important guideline which is widely used by clinical trial researchers and has significant impact for trial participants and patients,” wrote the organization in the press release summarizing progress during the June meeting.
New areas of harmonization
During the meeting, three topics were identified as new areas of ICH harmonization. Revisions are planned for the ICH Q1 Guidelines on Stability Testing and the related ICH Q5C Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products. Specifications for test procedures and acceptance criteria for new drug substances as laid out in ICH Q6A, as well as ICH Q6B, New Drug Products: Chemical Substances and Biotechnogical/Biological Products are also slated for revision. Finally, ICH is planning a new guideline on the plan and design of pharmacoepidemiological studies that use real-world data for medicine safety assessment.
At the meeting, ICH also supported the November 2020 updates to the ICH Reflection Paper on patient-focused drug development. The revised paper “presents opportunities for development of new ICH Guidelines to provide a globally harmonised approach to the inclusion of the patient’s perspective in a way that is methodologically sound and fit-for-purpose for both regulated industry and regulatory authorities,” wrote ICH.
ICH also reports there has also been a “steady increase” in the number of MedDRA subscribers with over new 540 subscribers in the last year, bringing the total number of subscribers to 6,800 organizations in over 127 countries. Further, efforts are underway to “support the language needs of users” by developing an Arabic translation and to continue translating MedDRA into the remaining languages of the European Economic Area.
The Saudi Food and Drug Authority (SFDA) joined ICH as a new member. Additionally, two new regulators joined the ranks of ICH observers: Azerbaijan’s Center for Drug Evaluation and the United Kingdom’s Medicines and Healthcare products Agency (MHRA). The total number of ICH members stands at 18 and the number of observers at 33.
In other areas, ICH announced that a survey showing “good progress” has been made by regulatory authorities in implementing ICH guidelines since the first survey was disseminated in 2019.
The next ICH Assembly meeting will be virtual and held on 17-18 November 2021.
ICH meeting


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