Background: This study was built on the previous 2019 and 2021 assessments where the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) selected CIRS to collaborate on the development and the conduct of this project.
Objectives: This study aimed to monitor the adequacy of implementation and adherence to ICH Guidelines by regulatory authorities. The objectives were to:
- To assist the Management Committee (MC) in determining whether ICH non-Standing non-Founding Regulatory Members would meet the eligibility criteria for the ICH MC elections in June 2024
- To allow participating Observers interested in future ICH Membership to reference the survey findings to confirm their eligibility
- To identify regulatory training and capacity building needs
Method: An online questionnaire and definitions developed by CIRS in collaboration with ICH were utilised. The questionnaire was completed in January-April 2024 by companies (assessing all the authorities) and authorities (assessing themselves). It assessed implementation and adherence to ICH Guidelines by all the ICH Non-Founding, Non-Standing Regulatory Members for Tier 2 and 3 Guidelines; ICH Founding and Standing Regulatory Members for selected new Tier 3 Guidelines; and ICH Observers on a voluntary basis for Tier 1 ICH Guidelines, where results for ANMAT, Argentina; SAHPRA, South Africa and NAFDAC, Nigeria were included in this report.
Results: 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.
Implementation of ICH non-Standing non-Founding Regulatory Members:
- For Tier 2 Guidelines: 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: 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).
Observers: The results show that implementation and adherence ranged from 33-100% across the three Authorities.
Conclusion: The results demonstrate authorities’ and companies’ continued commitment and support in ICH’s mission to achieve greater harmonisation worldwide and ensure that safe, effective, and high-quality medicines are developed, registered, and maintained in the most resource-efficient manner whilst meeting high standards. In addition, the study highlights progress made by authorities in implementing and adhering to ICH Guidelines since the 2019 and 2021 assessments and the results will be used to support training needs as well as ICH membership related activities.
