Background: This study was built on the previous 2018/2019 assessment where ICH selected the Centre for Innovation in Regulatory Science (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:

  • Assist the Management Committee in determining whether ICH non-Standing non-Founding Regulatory Members would meet the eligibility criteria for the ICH Management Committee (MC) elections in June 2021
  • Allow participating Observers interested in future ICH Membership to reference the survey findings to confirm their eligibility.

Method: An online questionnaire and definitions developed in 2018 and updated in 2019 by CIRS in collaboration with ICH were adapted for the purpose of this study. The questionnaire was completed in January-March 2021 by companies (assessing all the participating authorities) and authorities (assessing themselves only). This questionnaire focused on assessing implementation and adherence to ICH Guidelines by ICH non-Standing, non-Founding Regulatory Members (ANVISA, Brazil; NMPA, China; HSA, Singapore; MFDS, Republic of Korea; TFDA, Chinese Taipei and TITCK, Turkey) for Tier 2 and 3 Guidelines. The study was also open to ICH Observers on a voluntary basis, where INVIMA, Colombia; JFDA, Jordan; SAHPRA, South Africa and SFDA, Saudi Arabia participated in the study for Tier 1 ICH Guidelines.

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. 10 regulatory authorities (100% response rate) and 30 pharmaceutical companies (75% response rate) participated in the 2021 study to undertake gap analysis, indicating strong interest and support for this initiative.

Implementation of ICH non-Standing non-Founding Regulatory Members:

  • Tier 2: Two authorities implemented all of the Tier 2 Guidelines, while all of the authorities implemented the E2D and M4 Guidelines, followed by E2A (five out of six). Compared with 20191 report, results indicated an increase in implementation and adherence across most of the Tier 2 Guidelines
  • Tier 3: Five out of the six Regulatory Members implemented >70% of the Tier 3 Guidelines

ICH Observers:

  • Tier 1: Two out of the four ICH Observers implemented all three of the Tier 1 Guidelines

Adherence:

  • Across all the authorities, where implementation was confirmed, there was a good level of adherence to the ICH Guidelines, or it was too early to assess.

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 assessment and the results will be used to support training needs as well as ICH-membership related activities.

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