ICH survey shows strong level of guideline implementation

Regulatory NewsRegulatory News | 20 September 2021 |  By 

Most of the 55 guidelines from the International Council on Harmonisation that relate to quality, safety and efficacy, as well as multidisciplinary guidelines, have been adopted among its 10 non-founding members and observers and 30 pharmaceutical companies, according to the results of a new survey.
The survey was designed to monitor the adequacy and level of implementation to ICH guidelines by regulators and industry and complements one released in 2019 on the adoption of the guidelines among ICH founding members. (RELATED: ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry, Regulatory Focus, 8 November 2019) 
The survey assessed the level of implementation among six non-standing and non-founding regulators, including Brazil’s ANVISA, China’s National Medical Products Administration (NMPA), Singapore’s Health Sciences Authority (HSA), South Korea’s Ministry for Food and Drug Safety (MFDS), Taiwan’s Food and Drug Administration (TFDA) and Turkey’s Medicines and Medical Devices Agency (TITCK).
The four observers include Colombia’s National Food and Drug Surveillance Institute (INVIMA), Jordan’s Food and Drug Administration (FDA), South Africa’s Health Products Regulatory Authority (SAHPRA) Saudi Arabia’s Food and Drug Authority (SFDA). Most of the 30 pharmaceutical companies were global and all were innovators. The survey was completed in March 2021.
The survey showed a “strong level of implementation and adherence” to the guidelines as well as “alignment between the perception of the companies and the self-declaration of authorities studied” on their adherence to the guidelines.
Yet some guidelines are being implemented more slowly than others. For example, the survey found that the S5(R3) guideline on reproductive toxicity, the E9(R1) guideline on statistical principles for clinical trials and the ICH Q12 guideline on postapproval changes are either in the process of being implemented or not being implemented. Four authorities confirmed they are in the process of implementing ICH Q12.
The survey looked more in depth at the implementation of five “Tier 2” guidelines, including ICH E2D on post-approval data safety management, ICH M4 on the Common Technical Document (CTD), ICH E2A on clinical safety data management, ICH M1 on MEDDRA terminology, and ICH E2B (R3) on individual case safety reports.
It found that E2A, E2D and M4 had the widest adoption while there was less widespread uptake of E2B(R3) and ICH M1. Several reasons were given for the slow uptake, including:
  • additional requirements included in the guidelines
  • a lack of agency capacity to implement them
  • the guidelines conflict with local requirements
  • a lack of understanding of the guideline.
The survey’s results will be used to support training needs as well as ICH-membership related activities.
The survey aims to help the ICH Management Committee determine whether non-standing, non-founding regulatory members have met their eligibility criteria for joining and to help observers interested in future ICH membership to reference the survey findings to confirm their eligibility.
The survey was conducted by the Centre for Innovation in Regulatory Science (CIRS), an independent UK-based subsidiary of Clarivate plc, which is an international forum for industry and regulators.
ICH implementation report


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