ICH announces forthcoming documents on nitrosamine impurities, RWD
The International Council for Harmonisation (ICH) announced plans to issue two new documents: an addendum to the M7 guideline on assessing carcinogenic risk that would establish daily acceptable intake limits (AIs) for nitrosamine impurities and a reflection paper on harmonizing real-world data (RWD) in analyzing drug efficacy.These developments were announced on 12 June following a 5 June meeting in Fukuoka, Japan. ICH also noted that “significant milestones” had been reached on advancing other guidelines.
Plans are in the works to issue an addendum to the ICH M7(R2) guideline on “Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” to control the safety of nitrosamines through the development of a harmonized set of acceptable intakes (AIs).
The current ICH M7(R1) guideline labels nitrosamines as a “cohort of concern” but does not set daily intake limits for these compounds.
The ICH Assembly also endorsed an upcoming reflection paper, soon to be published, on harmonizing RWD to generate real-world evidence, with a focus on using this data to measure drug effectiveness. The paper will accommodate public comments received during a consultation held June-September 2023.
The ICH also noted “significant milestones” had been reached on advancing other guidelines, including the adoption of the ICH M12 guideline on “Drug Interaction Studies” and supporting M12 questions and answers (Q&As) and the release of a Step 2 ICH M14 guidance on the principles for planning, designing and analyzing pharmacoepidemiologic studies that use RWD for assessing the safety of medicines (RELATED: ICH adopts M12 guideline on drug interaction studies, releases draft M14 guidance on RWD, Regulatory Focus 28 May 2024).
Another milestone was the release of the ICH E2D(R1) draft guideline which harmonizes post-market safety reporting requirements as a Step 2 in February 2023 (RELATED: ICH consults on revised post-approval safety guideline that accounts for digital platforms, Regulatory Focus 16 February 2024).
In other new news, the ICH Management Committee approved the development of a new concept paper on general considerations for patient preference studies.
The ICH Assembly also approved the revision of Q4B(R1) Guideline on “Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions” which has not yet been published. “The revision reflects that responsibility for the maintenance of Q4B and its annexes is handed over to the Pharmacopoeial Discussion Group (PDG),” said an ICH announcement.
ICH further announced that “the new procedure takes account of the growth in ICH Regulatory Members in recent years and will give non-PDG pharmacopoeias the option to harmonise their method with the PDG method or to implement the PDG method in parallel of a local method.”
In other areas, a survey was released to understand the current level of implementation and adherence to ICH guidelines. The results of the survey, which has not yet been released, “demonstrate good progress made by Regulatory Authorities in implementing ICH Guidelines since the two previous surveys from 2019 and 2021.”
ICH also reported that the number of MedDRA users continues to grow, reaching more than 8,300 users in 134 countries.
The next ICH Assembly meeting will be 5 November 2024 in Montreal.
ICH
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