ICH decision on multi-regional clinical trials aims to benefit public health
18.12.2017 - The International Council for Harmonisation (ICH) met in Geneva, Switzerland from 11 to 16 November 2017. This was the first ICH meeting held in Switzerland, and it was organised and run by Swissmedic, the Swiss Therapeutic Products Agency, in close cooperation with the ICH Secretariat.
Among other decisions, the ICH Assembly approved the Health Sciences Authority, Singapore (HSA), as a new Regulatory Member. The Assembly also approved the Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Colombia (INVIMA), and the Bill & Melinda Gates Foundation (BMGF) as new Observers. With these new parties, the ICH Assembly now has 15 members and 24 observers.
Full details of membership are available on the ICH website (www.ich.org).
The ICH Assembly re-elected Lenita Lindström-Gommers (EC, Europe) and Dr. Toshiyoshi Tominaga (MHLW/PMDA, Japan) as Chair and Vice-Chair until November 2019.
Dr. Theresa Mullin (FDA, US) and Dr. Toshiyoshi Tominaga (MHLW/PMDA, Japan) were re-elected as Chair and Vice-Chair of the association’s Management Committee.
Planning and design of multi-regional clinical trials
With the increasing globalisation of medicines development, ICH adopted a major Guideline on the planning and design of multi-regional clinical trials. The ICH E17 Guideline will facilitate the acceptability of multi-regional clinical trials as part of global regulatory submissions in ICH and non-ICH regions. This is expected to have a direct public health benefit, in particular by encouraging more predictability and planning security around the approval of trials and the use of clinical trial data from a greater variety of countries and regions in the authorisation process.
Dedicated training and implementation materials will be prepared to accompany the Guideline, including the development of case studies to aid harmonised implementation. The Assembly agreed to create an Implementation Working Group (IWG) to maintain momentum for the implementation of this important Guideline.
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).
Swissmedic will apply the ICH E17 Guideline accordingly when it is published on the ICH website.
Draft Guideline on lifecycle management goes for public consultation
The ICH Assembly adopted the draft ICH Q12 Guideline on Pharmaceutical Product Lifecycle Management. There was agreement to begin an extended 12-month consultation of stakeholders.
Focus on paediatric medicinal products
Following agreement earlier in 2017 on the ICH E11 Guideline on Clinical investigation of medicinal products in the pediatric population, ICH decided to establish a standing Pediatric Expert Working Group. The purpose of the group is to provide centralised and consistent cross-functional and multi-regional paediatric expertise to other ICH expert working groups as issues and questions arise on existing and new Guidelines in this area.
The Assembly agreed on a Q&A document on the ICH S3A Note for guidance on toxicokinetics, which focuses on micro-sampling techniques in toxicokinetic assessment that have been enabled by the recent technological development of analytical methods.
Swissmedic will implement the Q&A document accordingly when it is published on the ICH website.
The M2 (Electronic standards) and M8 (eCTD) Expert Working Groups prepared harmonised guidance on submission of PDF files that was adopted by the Assembly and will be published on the ESTRI website (http://estri.ich.org/).
The Assembly also adopted v1.1 of the eCTD v4.0 Change Request and Q&A document prepared by the experts in the M8 group.
Swissmedic will implement the CR and the Q&A document accordingly when they are published on the ICH website.
The E2B(R3) EDQM Dose Form and Route of Administration Term User Guide was also adopted at the meeting. The implementation of E2B(R3) at Swissmedic is currently scheduled for 2019/2020.
The next ICH Meeting takes place in Kobe, Japan, from 2 to 7 June 2018.
What is the ICH?
The objective of the "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use" (ICH), founded in 1990, is to make recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines for the assessment and market authorisation of medicinal products for human use, thereby minimising duplication during development and the authorisation process. In October 2015 ICH reformed itself as a company under Swiss law with the new name of International Council for Harmonisation.
Further information can be found on the ICH website.http://www.ich.org/