ICH survey shows uptick in guideline implementation

A recent survey commissioned by the International Council for Harmonisation (ICH) found that the adoption of its guidelines has increased among its non-founding members and observers since 2019. In addition, there is a “good alignment” between companies and regulators on their adherence to the guidelines.

The survey, released on 1 October, was designed to gauge the level of implementation of ICH’s guidelines and builds on an earlier survey released in 2021. (RELATED: ICH survey shows strong level of guideline implementation, Regulatory Focus 20 September 2021)

The survey was meant to determine whether ICH non-standing non-founding members would meet the eligibility criteria for the ICH Management Committee (MC) elections in June 2024 and to “identify regulatory training and capacity building needs.”

The survey included ICH’s ten non-founding, non-standing regulatory members: Brazil’s Health Regulatory Agency (ANVISA), Mexico’s Federal Committee for Protection from Sanitary Risks (COFEPRIS), the Egyptian Drug Authority (EDA), Singapore’s Health Sciences Authority (HSA), the Republic of Korea’s Ministry for Food and Drug Safety (MFDS), the UK’s Medicines & Healthcare products Regulatory Agency (MHRA), China’s National Medical Products Administration (NMPA), Saudi Arabia’s Food and Drug Authority (SFDA), Taiwan’s Food and Drug Administration (TFDA), and Turkey’s Medicines and Medical Devices Agency (TITCK).

Five regulatory observers also participated, including Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT), Cuba’s Center for the State Control of Medicines, Medical Equipment and Devices (CECMED), Nigeria’s National Agency for Food and Drug Administration and Control (NFDAC), and South Africa’s Health Products Health Products Regulatory Authority (SAHPRA).

The survey found that regulators’ implementation of five Tier 2 guidelines increased from 47% in 2019, to 64% in 2021, and to 73% in 2024. The ICH guidelines are classified into three tiers based on their level of importance, with Tier I representing the most important guidelines.

The five Tier 2 guidelines include E2A on clinical safety data management, E2B(R3) on individual case safety reports, E2D on postapproval data safety management, M1 on MEDDRA terminology, and M4 on the Common Technical Document (CTD).

The survey also found that overall regulatory implementation of Tier 3 guidelines increased from 70% in 2021 to 79% in 2024. The increase was attributed to “an increase in implementation and adherence by ANVISA, Brazil; NMPA, China, and TITCK, Türkiye.”

For Tier 1 guidelines, the survey noted that the Q1 stability testing guideline and the E6(R2) guideline on Good Clinical Practices (GCPs) was implemented by ANMAT, NAFDAC and SAHPRA. The Q7 guideline on Good Manufacturing Practices (GMPs) for active pharmaceutical ingredients was implemented by two authorities and is the process of being implemented by one authority.

Authorities and companies were also asked about their views on the implementation status for the selected Tier 2 guidelines. The survey found that company’s perception of implementation status was generally aligned with the agency’s self-declaration of their implementation status.

The survey was conducted by the UK-based Centre for Innovation in Regulatory Science (CIRS), an independent subsidiary of Clarivate plc.

Implementation survey

ICH survey shows uptick in guideline implementation

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