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ICH Steering Committee Meeting and 
Sixth International Conference on Harmonisation
(ICH6)

 

"New Horizons and Future Challenges"

Osaka, Japan, November 15, 2003

The Sixth International Conference on Harmonisation (ICH6) took place in Osaka, Japan, from 12 to 15 November 2003. Over 1800 participants attended the Conference, representing regulatory and other government agencies and industry from ICH as well as non-ICH regions. The Conference followed the regular meetings of the ICH Steering Committee and its Expert Working Groups earlier in the week where the continued development of new guidances progressed as did work on the implementation of existing guidelines.

ICH6

With a view to determining future challenges for the ICH process in the evolving pharmaceutical environment, the Sixth International Conference on Harmonisation focused on areas such as new technologies in the discovery of innovative drugs, opportunities and new challenges for regulatory harmonisation, pharmacovigilance and global cooperation with regulatory harmonisation initiatives outside the ICH regions. The practical implementation of the Common Technical Document (CTD) - the common format for licence application in the three ICH regions - was also an important focus of the ICH6 Conference.

Three satellite sessions took place before the plenary Conference: "Partnerships in Harmonisation", "Gene Therapy" and "MedDRA Users' Group". The session on Partnerships in Harmonisation reflected the ICH commitment to establishing collaborative efforts through expanded Global Cooperation Group (GCG) activities with non-ICH harmonisation initiatives. The session on Gene Therapy reflected the importance of communication on new scientific areas.

His Excellency Dr. Eisuke Mori, Senior Vice-Minister of Health, Labour and Welfare, opened the plenary session of the ICH6 Conference stressing that in the rapid progression of global drug development the ICH principal philosophy, "…harmonised technical requirements to facilitate the development of new drug products to benefit patients and public health by ensuring timely access to innovative drugs…" is of ever increasing importance. Dr. Mori praised both the value of the ICH process and its achievements to-date and noted that the ICH process has now entered a new phase of activity. He re-confirmed MHLW's full and strong commitment to the ICH efforts, which contribute in turn to the improvement of public health across the ICH regions and beyond.

The results of a survey on the impact of ICH were presented at the Conference. The outcome clearly showed a high degree of satisfaction by both regulatory authorities and industry with the completed ICH guidelines. A major part of the survey focused on the practical use and implementation of the CTD and the electronic CTD (eCTD). Several questions also covered regulatory authorities' and industries' views and expectations regarding the future activities under ICH. The survey showed unanimous support from both sides for a continuation of the ICH activities at two levels: to carry on with the development of new harmonised guidelines where and when necessary and to maintain the existing guidelines keeping them up-to-date with the most current science and best practice.

The ICH6 closing plenary session "Future Challenges: New Approaches for the Development-Assessment of Innovative Therapies" highlighted a number of novel areas which might be considered for future international scientific dialogue, such as new technologies to enhance drug discovery, specific issues regarding biological medicines derived from new biotechnological processes and pharmacogenetics/pharmacogenomics techniques to target medicines. It was stressed that ICH should pursue its efforts in implementing and maintaining existing guidelines, in order to prevent inconsistent implementation across the ICH regions, and should keep on making efforts for developing harmonised guidelines on new topics with the spirit of collaboration. ICH should pursue its endeavours towards global cooperation with non-ICH regions. It was also reaffirmed that public health promotion and protection were the foundation of the ICH harmonisation activities.

ICH Steering Committee Meeting

A number of harmonisation initiatives and topics made significant progress prior to the ICH6 Conference.

A last series of CTD Q&As ("Questions & Answers") was endorsed by the Steering Committee and will be posted on the ICH web site.

The final version of the guideline on "Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting" (topic E2D) was adopted (Step 4 of the ICH Process).

Two draft guidelines reached Step 2 of the ICH Process and will be released for consultation in the three ICH regions: "Pharmacovigilance Planning" (topic E2E), and the quality part of "Comparability of Biotechnological and Biological Products subject to Changes in their Manufacturing Process" (topic Q5E).

The Steering Committee noted the good progress of the discussions related to the new ICH initiative on a risk-based approach to Drug Product Quality and Good Manufacturing Practices (GMP): "Pharmaceutical Development - Quality by Design" (topic Q8) had their first official EWG meeting and "Risk Management" was adopted as a new ICH topic (topic Q9).

The Steering Committee agreed to launch a new harmonisation initiative on "Data Elements and Standards for Drug Dictionaries" (topic M5) and an official expert working group will start to work on this topic according to a defined business plan.

Results of a survey on "Immunotoxicology Studies" requirements and practices in the three regions were presented to the Steering Committee members who agreed that the scientific data supported formalising this initiative as a new ICH topic (topic S8).

Concerted discussions will be pursued on "Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs" (topic E14), and "Safety Pharmacology Studies for Assessing the Potential for Delayed Ventricular Repolarization - QT Interval Prolongation by Human Pharmaceuticals" (topic S7B).

The ICH Steering Committee also heard the report from the MedDRA Management Board, which had met on November 7th and 8th. The Contract with the MedDRA MSSO management organisation has been renewed for a period of three years. Further information on MedDRA is available at the MSSO web site: http://www.meddramsso.com/

The next ICH Steering Committee Meeting will be held in Washington DC in June 2004.

For further information, please contact:
ICH Secretariat (c/o IFPMA) 30, rue de St.Jean, PO Box 758, 1211 Geneva 13, Switzerland

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