ICH: Report of 2024 Implementation Survey

The ICH has published the 2024 Implementation Survey Report. It contains the results of a study aimed to monitor the adequacy of implementation and adherence to ICH Guidelines by regulatory authorities – continuing the assessment initiated in 2019 and repeated in 2021.

The results demonstrate that in general, there is a strong level of implementation and adherence across the agencies studied, as well as alignment between the perception of the companies and the self-declaration of authorities studied. 19 regulatory authorities (100% response rate) and 26 pharmaceutical companies (70% response rate) participated in the 2024 study to undertake gap analysis, indicating strong interest and support for this initiative.

The ICH summarises the results as follows:

Non-Founding, Non-Standing Regulatory Members (e.g. ANVISA, Brazil, HSA, Singapore, MHRA, UK):

Results for 2024 indicate that:

• For Tier 2 Guidelines (only for ICH Non-Founding, Non-Standing Regulatory Members): Implementation and adherence for Tier 2 Guidelines ranged from 40-100% across the ten authorities. Nine out of 10 authorities implemented and adhere to ≥80% of Tier 2 Guidelines. Some challenges for implementation and adherence were highlighted, particularly for M4, as well as E2B(R3), E2D and M1.
• For Tier 3 Guidelines: Implementation and adherence for Tier 3 Guidelines ranged from 5-95% across the ten authorities. Seven out of ten authorities implemented and adhere to ≥50% of Tier 3 Guidelines. Guidelines with least implementation and adherence across the authorities included: Q4B, Q12, Q13; S1B(R1); E8(R1), E15, E16, E19 and, and M10.

The results also demonstrate progress made by authorities in implementing ICH Guidelines since the 2019 and 2021 assessment:

• For Tier 2 Guidelines: implementation and adherence increased from 47% in 2019, to 64% in 2021 and 73% in 2024. This was driven by an increase in implementation of E2B(R3) and M1.
• For Tier 3 Guidelines: the increase was from 70% in 2021 to 79% in 2024 (not studied in 2019). This was driven by an increase in implementation and adherence by ANVISA, Brazil; NMPA, China, and TITCK, Türkiye, which is now similar to the other Regulatory Members.

Founding and Standing Regulatory Members ((e.g. EC, Europe, FDA, United States, MHLW/PMDA, Japan): The results show for the selected Tier 3 Guidelines that implementation ranged from 86-100%, whereas adherence ranged from 28-86% across the five authorities. Guidelines with least implementation and adherence across the authorities were E19, M10, Q13 and S1B(R1).

Regulatory Observers (ANMAT, Argentina, CECMED, Nigeria, SAHPRA, South Africa): The results show that implementation and adherence ranged from 33-100% across the three authorities.

Source:

ICH: News