ICH Assembly in Kobe, Japan, 2 to 7 June 2018
The International Council for Harmonisation (ICH) met in Kobe, Japan, from 2 to 7 June 2018. In one of the remaining steps in reforming the ICH, the Assembly elected additional members to the Council’s Management Committee. In addition to the Founding and Standing Members, the Management Committee now includes the authorities from China (CFDA), Singapore (HSA) and South Korea (MFDS) as regulatory members, as well as BIO and IGBA as industry members.
Among other decisions, the ICH Assembly approved the Chinese Taipei Food and Drug Administration (TFDA) as a new Regulatory Member, and MMDA, Moldova, NPRA, Malaysia, SCDMTE, Armenia and TİTCK, Turkey as new Observers. With these new parties, the ICH Assembly now has 16 members and 27 observers.
Guidance documents adopted
The Assembly adopted the following guidance documents at its Kobe meeting (Step 4 of the ICH process):
- Revision of Q&As for the Electronic Submission of Individual Case Study Reports (E2B(R3));
- eCTD v3.2.2 Change Request and Q&A Document v1.31 (M8);
- eCTD v4.0 Implementation Package v1.2 (M8);
- eCTD v4 Change Request and Q&A Document v1.2 (M8);
- Specification for Submission Formats for eCTD v1.2 (M8);
- The question and answer document on nonclinical evaluation for anticancer pharmaceuticals (S9) had already been adopted by written procedure in April 2018.
In Switzerland, the ICH Guidelines are deemed to be the documents representing the current state of science and technology once they have been approved by consensus (Step 4 of the ICH process) within the ICH organisation (cf. Swissmedic Journal 05/2006, p. 504).
Once published on the ICH website, the guidance documents are applicable in Switzerland.
When eCTD v4 is introduced, which should be within the next few years, Swissmedic will implement the above-mentioned guidance documents on eCTD accordingly.
The following draft guidance documents were adopted for public consultation (Step 2b of the ICH process):
- Biopharmaceutics Classification System-based Biowaivers (M9);
- The Guideline on Elemental Impurities: Revision to Cadmium-inhalation Permitted Daily Exposures (Q3D(R1)) had already been endorsed by written procedure in May 2018.
ICH prepares for future new topics
The Assembly agreed to begin work on harmonising the following three new topics:
Analytical Procedure Development and Revision of Q2(R1) Analytical Validation (Q2(R2)/Q14);
- Continuous manufacturing (Q13);
- Clinical Electronic Structured Harmonised Protocol (‘CeSHarP’) (M11).
It was also decided to address two other new topics, but work on these will start at a later point in time:
- Adaptive Clinical Trials
- Drug Interaction Studies
Training and stakeholder engagement to enhance implementation and adherence
The growing global significance of ICH entails a greater focus on training and stakeholder outreach.
The Assembly noted the development of training tools for regulators, industry and other stakeholders involved in drug development as a way of ensuring consistent implementation of ICH guidelines. The training strategy will be delivered through trusted partner programmes that extend across the ICH regions, and will be in addition to the efforts of the ICH Expert Working Groups to develop their own training materials for guidelines.
In parallel, work is underway to fully map the implementation of ICH guidelines by current and future ICH members. Once available, the result will be published on the ICH website so that all stakeholders can identify how ICH guidelines are being implemented in their region.
The next ICH Steering Committee Meeting will be held in Charlotte, North Carolina, from 10 to 15 November 2018.
