10 November 2011

“International Harmonisation Reaches Milestone on Preclinical Safety”

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its working groups met in Seville, Spain from 5 - 10 November 2011.

Safety Update
Following an extended consultation period, the SC approved a revised ICH S2(R1) Guideline for genotoxicity testing and data interpretation for medicines intended for human use. This revised Guideline reflects state of the art options for genotoxicity testing and is expected to improve risk assessment of human medicines. It is also expected to reduce the number of animals used for genotoxicity testing alone in the implementing regions and thus to enhance the efficiency and use of resources in the development of medicines.

Quality Update
The Quality Implementation Working Group (IWG) completed three documents on points to consider on ‘Process validation/ Process verification’, ‘Role of Modelling in Quality by Design’ and ‘Design Space’. Combined with previously finalised question-and-answer-documents (Q&As) and training material these documents provide a complete set of guidance to manufacturing of pharmaceuticals in the twenty first century.

Global Outreach Activities
Having opened in 2010 quality, safety and efficacy expert working groups (EWGs) to experts from non-ICH regions, representatives from Chinese Taipei, Korea and Singapore regulatory authorities participated to the activities of EWGs on Genotoxic Impurities (M7), Metal Impurities (Q3D), Periodic Benefit Risk Evaluation Report (E2C), Photosafety (S10) and Development and Manufacture of Drug Substances (Q11). The ICH Global Cooperation Group welcomed for the first time representatives of the East African Community (EAC), a regional harmonisation initiative composed of Burundi, Kenya, Rwanda, Tanzania and Uganda.

The EWG working on the Electronic Common Technical Document, eCTD (ICH M8) released an updated Q&A document. This update clarifies which PDF versions are acceptable in all regions and advises how to organise excipient information within the eCTD.

1.  The S2(R1) Guideline merges the original two ICH S2A (dated 1995) and S2B (dated 1997) Guidelines into one.
2.  All documents adopted at this SC meeting will be published on the ICH website shortly.
3. The ICH Global Cooperation Group is a subgroup of the ICH Steering Committee and is composed of one representative from each of the six parties on the ICH Steering Committee, plus three Observers (WHO, Health Canada and EFTA) and IFPMA are also part of the GCG. Regional Harmonisation Initiatives, namely APEC, ASEAN, EAC, GCC, PANDRH and SADC, as well as Drug Regulatory Authorities and Departments of Health from Australia, Brazil, China, Chinese Taipei, India, Republic of Korea, Russia and Singapore have also been invited to designate permanent representatives to the GCG.
4.  More information on the work of the ICH can be found on its website: www.ich.org
5.  The next meeting of the ICH Steering Committee and its expert working groups will be held in Fukuoka, Japan from 2 - 7 June 2012.

For further information, please contact:
ICH Secretariat
Chemin Louis-Dunant, 15, P.O Box 195
1211 Geneva 20, Switzerland
Tel: +41 22 338 3206   E-mail: admin@ich.org
Fax: +41 22 338 3230  Website: www.ich.org

Download the PDF version of the press release