ICH adopts GCP Annex 2, announces progress on other guidelines
The International Council for Harmonisation (ICH) has announced the adoption of Annex 2 to the guideline on Good Clinical Practices (GCPs) E6(R3). This annex focuses on the collection of data from a wider range of sources for clinical trials, including decentralized trials and pragmatic clinical trials (PCTs).
ICH made this recent announcement following a meeting of its biannual assembly meeting held in Rio de Janeiro, Brazil.
ICH members also reported that progress has been made on various guidelines related to efficacy, safety, and in the multidisciplinary areas.
The finalized version of Annex 2 does not include any major changes from the draft guideline issued in November 2024. (RELATED: ICH touts “significant milestones” reached this year in adopting and advancing guidelines, Regulatory Focus 14 November 2024)
Several updates have been made, including clarification on the definition of digital health technologies used to collect participant data for clinical trials. Also, it is now stated that informed consent can be obtained through a video call. Additionally, there is new information in the investigator oversight section.
In the protocol and design section, a new statement has been added indicating that “sponsors considering incorporating trial-related activities that are part of usual clinical practice…. should assess whether such an approach is for purpose for use in the trial and complies with applicable regulatory requirements.”
Moreover, in the section on real world data considerations, new text has been introduced stating that that the sponsor must ensure the fitness of purpose of the RWD.
Other guidelines
The Pharmacopeial Discussion Group (PDG) also provided an update to the ICH assembly regarding the ongoing maintenance activities of ICH Q4B. The assembly also received reports from its various working groups, which indicated that “good progress” has been made on guidelines across several areas, including quality, safety, efficacy, and multidisciplinary topics.
Under quality, the guidelines include ICH Q1, which focuses on stability testing; ICH Q3E, addressing extractables and leachables; ICH Q5E, which centers on the comparability of advanced therapy medicinal products (ATMP); and ICH Q6(R1), covering specifications.
For efficacy, relevant guidelines are ICH E21, which concentrates on pregnant and breastfeeding individuals; ICH E22, which pertains to patient preference studies; and ICH E23, addressing real-world evidence (RWE).
Regarding safety, ICH S13 discusses oligonucleotide-based therapeutics. Additionally, multidisciplinary guidelines include ICH M4Q(R2) related to the Common Technical Document (CTD); the ICH M7 addendum concerning nitrosamines; the ICH M13 guideline on bioequivalence; and the ICH M18 guidance on biosimilars.
The ICH Technology Task Force updated the assembly on its efforts to define the functional and technical requirements for a digital platform that will support the development and implementation of ICH guidelines. The report can be found on the ICH website.
In other areas, ICH approved a strategic vision guiding the group’s work over the next three years, which includes a revised process for selecting new topics for guideline development.
The group also released MedDRA Version 29.0, which is now available in 27 languages. The announcement highlights that training in MedDRA has reached over 16,000 users across 108 countries, with “strong engagement” in Latin America, where many regulatory authorities require the use of MedDRA.
Two new regulators joined the ranks of ICH observers: Pakistan’s Drug Regulatory Authority of Pakistan (DRAP) and New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe). The total number of ICH members stands at 25 and the number of observers is now at 43.
