ICH E8 (R1) General Considerations for Clinical Studies and E14 Clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects of Non-antiarrhythmic Drugs will come into effect in July 2023.
On August 12, 2022, the National Medical Products Administration (NMPA) published announcement (No. 61 of 2022) about its decision to apply the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines on E8 (R1) General Considerations for Clinical Studies and E14 Clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects of Non-antiarrhythmic Drugs.
The requirements are as follows:
- From July 31, 2023, the requirements for the initiation of clinical drug according to E8(R1) shall apply. This will mean that from the date of implementation version E8: General Considerations for Clinical Studies shall cease to apply.
- From July 31, 2023, the relevant requirements for the initiation of clinical drug research according to ICH E14 shall apply. ICH E14 was implemented by ICH on May 12, 2005.
Highlights
- Compared with ICH E8 first published by the ICH on July 17, 1997, E8 (R1) General Considerations for Clinical Studies has undergone major framework and content revisions
- ICH E8(R1) is the first reform step towards the comprehensive revision of ICH E6 Good Clinical Practice initiated by the ICH in 2017. The new version of E8 takes the realization of the latest concept of “fit for purpose” data quality as one of the basic considerations for all clinical research. It also clearly adopts the Quality by Design (QbD) concept to drive the quality of clinical research, in order to improve efficiency and success rate. Combined with the updated content, it can be expected that the quality management concept in the field of clinical research will mean that quality must be part of the design of a clinical trial.
- ICH E14 Clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects of Non-Antiarrhythmic Drugs is the first ICH guideline to be applied in China. The guidelines provide advice on the design, conduct, analysis, and interpretation of clinical studies to help evaluate the potential role of drugs in delaying cardiac repolarization.
- It is worth mentioning that on July 9, 2022, China´s Center for Drug Evaluation (CDE) issued a notice to publicly solicit domestic stakeholder opinions on ICH guideline M12: Drug Interactions which is required to be released in September 2022. Feedback via email (lil@cde.org.cn; fushj@cde.org.cn) before September 30. Once the ICH member states agree on the revision of this guideline, they will implement ICH M12 successively. Drug applicants should follow this guidance in anticipation (see Internal links) to guide drug development and understand regulatory requirements.
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