Special Report . . . Implementation and implementation of the ICH Guidelines (below)

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overview of thebackground informationmethodsresultsPart 1: Characteristics of participating enterprises Part 2: Implementation of the Guide Part 3: Implementation of the Guide Annex 1: Definitionof Annex 1: Research ToolAnnex 2: Response Summary
Excerpts from the 2019 project report, International Coordination Of The Monitoring of Technical Requirements for Drug Registration for Persons (ICH) Guidelines.
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Special Report.The implementation and implementation of the ICH Guide (above)
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. Results Part 2: Implementation of the Guide
implementation:
requested regulators and businesses to provide their views on the implementation of the selected guidelines. The first bar in the figure below represents the regulator's self-assessment, and the second bar represents the number of corporate replies. A summary analysis of regulators by ICH membership category, categorizing the guidelines by levels 1, 2 and 3. A summary of the responses of all 15 participating regulatory agencies is provided in Annex 3.

key information
based on the regulator's self-assessment of the implementation of the Guide, the guidelines are most implemented among the members of the founding/permanent governing body and are generally considered to have been implemented;level 1 guide is the most implemented, followed by the guidelines for levels 2 and 3.companies' views on implementation are basically the same as those of regulators, but some differences --- such as E2B and M8 should be further investigated.such differences may be caused by differences in understanding of the definition of execution. Other reasons may also be time-delayed or incomplete corporate knowledge, indicating the need to inform and/or improve communication with regulators on the implementation of the guidelines.


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the revision of the implemented Guide:
asked enterprises that responded to "executed" whether the unrevised ICH Guide had been implemented (which amounts to a study of full implementation) or whether the original ICH Guide had been revised by adding or modifying certain elements, concepts or principles. It should be noted that the revision of the ICH Guide is likely to be accepted and fully implemented as long as it has an objective basis (the basis for the next question is asked). However, the purpose of the question is to determine whether there is a revision, whether or not it is reasonable.

key information
in general, regulators say most of the guidelines are not directly implemented with amendments.the highest proportion of amendments among observer members, followed by the members of the regulatory body and the lowest proportion of founding/permanent regulators. In addition, some guidelines have been revised more, such as Q1, Q7, and E2D.overall, the perception of companies is in line with the regulator's self-assessment.We have also noted some differences, which may be somewhat different in the interpretation of the guide. This may seem like a regulator-specific issue, but some guidelines are more divisive, such as the M4.


.. The basis for the revision of the guidelines:
to ask companies that have responded to "implemented revised guidelines" and whether regulators provide an objective basis for the revision, which is equivalent to full implementation. This may include actions taken to include additional information outside the guide where the guidance is too demanding and does not provide adequate guidance. Non-objective and reasonable amendments to increased regulatory requirements may result in inadequate implementation. The deletion of important regulatory requirements may also lead to inadequate implementation.key information
all regulators consider the amendments reasonable, i.e. they are clear and easy to implement, without actually increasing regulatory requirements.overall, the perception of companies is in line with the regulator's self-assessment. The corporate view further indicates that the frequency with which unreasonable revisions are added to the Guide is very low, mainly among observer members, followed by regulatory members.overall, there are small differences in regulatory/corporate responses, and there can be a number of reasons for disagreements: 1) the small number of companies that disagree, which reflects the specific experience of the business and the potential need for internal training/education, and 2) the high number of divergent businesses, indicating that regulators need to consider the understanding and/or interpretation of the guidelines internally.the general increase in unreasonable revisions to certain guidelines indicates the need for clarity on the guidelines themselves, such as Q1.


.. The basis for inadequate implementation:
the following three figures, respectively, for the founding/permanent regulatory bodies members, members of the regulatory bodies and observers to choose the revised guide is unreasonable, and thus causes the reasons for inadequate implementation of the summary statistics.

key information
overall, the best response to the best rate of the regulatory body across the board is Q1. More specifically, the firm provides justification for Q1 among the founding/permanent governing body members, while the governing body is Q1 and E2A, and finally, the observers are Q1, E2A, E2D and M4 (number of enterprises). the main reason for inadequate is to 'include requirements other than the definition of the Guide without objective basis, where the Guide clearly provides for it's not clearly defined'. The second most common reason for is that the Guide 'fails to contain all the relevant elements, concepts and principles of the ICH Guide and fails to provide an objective basis for the removal of some requirements in the Guide'. . Analysis of q1 free text evaluation s findings of the following reasons for selecting a larger number of regulatory agencies are: site-specific stability requirements exceed ich requirements (n?4) detection time planning and duration (n?4) local or regional requirements (n?4) additional monitoring analysis (n?4)

founding permanent / regulatory members
only for Q1 has a basis for inadequate implementation of 3 enterprises.


. observers

. Q1, E2A, E2D, and M4 all provide responses from 3 companies, with some of the related to new requests, followed by requests for deletion (especially E2A).
. Results Part 3: Implementation of the Guide
the implementation of the Guide:
please confirm the full implementation of the Guide (without revision or reasonable revision) by the organizations presenting their views on the implementation. The implementation is related to the practice of whether regulators adhere to the full range of clearly relevant elements, concepts and principles of the ich Guide. A composite analysis of regulators is performed by ICH membership status and the guidelines are categorized by levels 1, 2 and 3.

key information
, all regulators believe they are able to fully implement the guidelines. In general, the views of the business are consistent with the regulator's self-assessment, or the existing experience is limited and the assessment conclusions are not yet available, such as E17. According to the corporate view, the guidelines are highest among the founding/permanent governing body members, followed by regulatory members and observer bodies. . Regulators/companies are very divided and can have multiple reasons for the disagreement. similar to performance, , if there is a small number of different enterprises, it reflects the specific experience of the enterprise, which may require in-house training/education. if there are more companies that disagree, it means that regulators need to conduct internal considerations about the interpretation and/or training of the guidelines to ensure that the interpretation of the guidelines is one." , and some of the guidelines are generally more divided, indicating the need to clarify the guidelines themselves, such as M4, E2A, q1.


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. Reasons for inadequate implementation:
the following three charts provide a summary of the reasons for the inadequate implementation of the selection of designated guidelines by members of the founding/permanent regulatory bodies, members of the regulatory bodies and observers, respectively. Provide respondents with the same reason options as inadequate implementation, and add five options that are particularly relevant to the practice and experience of regulatory bodies (see annex 2).

key information
. Similar to the results of the under-executed reason stakes, the guideline for the highest under-response rate among all regulatory bodies is Q1. More specifically, the founder/regular the governing body provides justification for E2A, E2B and E2D, while the governing body is Q1, Q7, E6, E2A, E2D and M4, and finally, the observers are Q1, Q7, E2A, E2D, M1 and M4 (number of businesses). . There are a variety of reasons for inadequate implementation, but the main reasons for adding other elements (similar to those for inadequate implementation) and "other local guides conflict with the ICH guidelines and make it difficult to fully implement the guidelines". For members and observers of regulatory bodies, another main reason is that "the application of the guidelines is not uniform;
. Founding/Permanent Regulatory
for E2A, E2B and E2D, there are more than 3 corporate responses, with the largest response to the local guidelines, followed by the new requirements
regulatory members
for Q1, Q7, E6, E2A, E2D and M4, there are more than 3 business responses, with a variety of reasons, with the largest response to the new requirements related to the relevant response.


. Observer
responses to Q1, Q7, E6, E2A, E2D, M1 and M4 from more than three companies for a variety of reasons, with the largest number of responses related to the non-uniform application of new requirements and guidelines.
. Conclusion
Phase 2a study shows that a comprehensive and comprehensive opinion survey can be conducted because of the good response rate and strong interest. The evidence-backed findings are summarized as follows:


- overall, strong evidence that regulators are able to implement and follow ICH guidelines, and that regulators' self-assessments are consistent with the views of most of the guidelines and regulators.


. - Implementation of the ICH Guide:
based on the self-assessment of regulatory bodies, the guidelines of founding/standing regulatory members are the most effective, followed by regulatory members and observer agencies. The company's view of implementation is generally consistent with the regulator's self-assessment.
the adequacy of the implementation of the
-ICH Guide (based on the revision):
generally speaking, regulators claim that most of the guidelines are not directly implemented without amendments, and all regulators consider the revisions to be objective and reasonable for the revised guidelines. Overall, the company's view is consistent with the regulator's self-assessment.

- The implementation of the ICH Guide:
all regulatory bodies that identify enforcement are considered to be able to implement the guidelines, i.e. fully apply the guidelines in their daily work . In general, the views of businesses are consistent with the self-assessment of regulators, or the limited experience available is not yet possible.


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in general, the variance analysis shows that the regulator's self-assessment is highly consistent with the company's views, but there are some differences. Objective reasons and specific examples largely support these differences, but differences and differences can be used to support the work of regulators and enterprises in training and capacity-building. . In addition, the results of the study can be used to support relevant decisions on ich member applications, transparent communication on the implementation of the Guidelines, improved relevance of ICH training activities, and future revisions of the ICH Guidelines. Finally, the next step is to refine the methodology based on feedback from this study so that it can be studied again to monitor changes, or it can be applied to other guidelines and regulators, especially in view of the addition of IcIs.