ICH touts “significant milestones” reached this year in adopting and advancing guidelines
The International Council for Harmonisation (ICH) announced that “significant milestones” have been reached this year in advancing guidelines on model-informed drug development (MIDD) and Good Clinical Practices (GCPs) on the collection of data from non-traditional clinical trials, such as decentralized trials and pragmatic clinical trials (PCTs). Both guidelines were released on 6 November and are open for public consultation until 28 February 2025.Other notable achievements were the adoption of a guideline on extrapolating information from adult studies to pediatric studies and assessing bioequivalence for immediate-release solid oral dosage forms.
These advances were announced by ICH on 13 November following its meeting 5-6 November in Montreal. These meetings were preceded by meetings of the ICH Management Committee (MC) and the MedDRA Management Committee.
The release of Annex 2 of the ICH E6(R3) guideline covers GCP considerations from collecting data from a wider use of data sources for clinical trials, including decentralized trials, PCTs and real-world data (RWD) elements.
The other notable action was the release of draft ICH M15 guideline on General Principles for Model-Informed Drug Development (MIDD). When finalized, the guideline is expected to cover general principles and best practices for using MIDD and will harmonize standards related to documentation, model development, model assessment and data analysis.
ICH also just released for public consultation a new ICH S13 concept paper on “Nonclinical Safety Studies for Oligonuceloitide-based Therapeutics.” The paper was released on 3 November. ICH plans to release a guideline in June 2025.
Other achievements include the August adoption of the ICH E11A guideline on pediatric extrapolation that aims to harmonize the various terminology and approaches related to pediatric extrapolation to expedite the approval of new drugs for the pediatric population. (RELATED: ICH adopts E11A guideline to spur pediatric drug development, Regulatory Focus 23 August 2024).
An ICH concept paper notes that there’s a 7-10 year gap between the drug’s approval in the adult population and the inclusion of pediatric information in product labeling because of differing extrapolation principles.
Another milestone touted by ICH was the adoption of the M13A guideline in July that aims to harmonize the framework for assessing the bioequivalence (BE) of immediate-release solid oral dosage forms and assessing BE after postapproval changes; ICH also released a questions and answer document accompanying the guideline. (RELATED: ICH adopts M13A guideline on bioequivalence testing, Regulatory Focus 6 August 2024).
In other areas, ICH welcomed a new member: Uzbekistan’s Center for Pharmaceutical Product Safety (CPPS), and two new observers, Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID), and Thailand’s Food and Drug Administration (FDA). ICH now has 23 members and 39 observers.
ICH also recently released MedDRA Version 27.1, which is now available in 24 languages, reflecting the addition of the Croation, Lithuanian, and Icelandic languages. The MedDRA Points to Consider Companion Document Version 3.0 has also been released which features a section manufacturing and quality system issues.
The next ICH Assembly meeting will be held on 13 May 2025 in Madrid.
ICH
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