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U.S. Department of Health and Human Services


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International Conference on Harmonisation (ICH) Press Release: "Step 4 for the ICH6 Program"

Brussels, Belgium, Europe, July 17-18, 2003

The International Conference on Harmonisation (ICH) Steering Committee and its expert working groups met in Brussels, Belgium, from July 15th to 18th, 2003.

The Steering Committee discussed and agreed to the content of the program for the ICH6 Conference, "New Horizons and Future Challenges", to be held in Osaka, Japan, from November 12th to 15th 2003. A detailed Final Announcement for the ICH6 Conference will be posted shortly on the ICH Web Site (www.ich.org).

The implementation of the common format for submission in the three ICH regions, the CTD (Common Technical Document), was still a major focus of discussions. Additional sets of CTD Q&As ("Questions & Answers") were reviewed by the Steering Committee and will be posted on the ICH web site once endorsed. These Q&As relate to general matters (particularly on granularity, i.e. subdivision of sections and organisations of individual documents), to the specific parts of the CTD and, to a large extent, to the electronic CTD (eCTD).

In addition to their work on the Q&As, the eCTD Working Group finalised the Change Control Process for the eCTD specifications and reviewed a large number of change requests. The eCTD group also adopted an interim solution for Study Reports specifications.

The Steering Committee was pleased to hear the positive outcome of a brainstorming workshop on initiatives related to a risk-based approach to Drug Product Quality. This session was attended by more than 60 designated experts from the six ICH parties, observers and non-ICH parties. The workshop discussion led to a general agreement on a high level vision: a harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to risk management.

The Steering Committee agreed that the experts from the six parties will work further on two areas:

  • on Pharmaceutical Development incorporating elements of Risk and Quality By Design, and covering the product lifecycle.
  • on a better definition of the principles by which Risk Management is integrated into decisions regarding Quality including GMP compliance both by the regulators and industry.

Industry will, in addition, produce a Quality Systems Scoping Document including GMP as a subset, which should address areas of perceived differences in the three regions.

It was also agreed to include a one-hour session of presentations on these GMP-related discussions and initiatives in the programme of the ICH6 Conference.

The E2B(M) implementation working group reported on its work on the Q&As concerning the implementation issues with the standard for electronic reporting "Data elements for the transmission of individual case safety reports". A first series of Q&As was adopted and signed-off as Step 4, and will be posted on the ICH Web Site (www.ich.org). The group will pursue its activities through regular teleconferences, and is planning to meet again in November in Osaka to clarify further concerns by agreeing additional Q&As and to develop a Concept Paper to address solutions for key issues relating to the implementation of E2B(M), which might require a revision of the existing guideline.

(Reminder: a section is available on the ICH Web Site for posting Questions on E2B(M), as well as a special E-mail address: question-to-E2B-guideline@ifpma.org).

The guideline on "Post-approval Safety Data Management" (topic E2D) was signed-off by as Step 2 the six ICH parties. The Steering Committee was also pleased to note the progress with the other pharmacovigilance guideline "Pharmacovigilance Planning" (topic E2E): the expert working group discussions focused primarily on the pharmacovigilance specifications and the structure of the pharmacovigilance plan. The group still needs to resolve some divergences regarding the design and conduct of post-approval safety studies, but is hoping to reach Step 2 by the next Steering Committee meeting in November 2003 in Osaka.

An informal discussion was held regarding the proposal made by the WHO in February 2003, to consider the development of an International Drug Dictionary under the auspices of the ICH. Further informal discussions will take place in conjunction with the next Steering Committee in November 2003 in Osaka.

The guideline on "Comparability of Biotechnological and Biological Products" (Q5E Topic) is also likely to reach Step 2 in November 2003 in Osaka.

The Steering Committee was informed about the work on the two guidelines dealing with evaluation of potential risks for QT/QTc Interval Prolongation:

  • "Safety Pharmacology Studies for Assessing the Potential for Delayed Ventricular Repolarization - QT Interval Prolongation" (Topic S7B), currently at post-Step 2 level,
  • "Clinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential for Non-Antiarrythmic Drugs" (Topic E14), which is progressing well.

To ensure optimal coordination between the two guidelines, the Steering Committee recommended that workplans of both topics be aligned (i.e. to reach a Step 2 on E14 and issue a revised Step 2 for S7B in Osaka in November 2003). In this way, final adoption of the two documents could happen simultaneously at the following Steering Committee meeting (June 2004 in Washington DC).

The Steering Committee was updated on the outcome of the MedDRA Management Board (MB), which met in Brussels, on July 13-14, 2003. The Management Board agreed to release MedDRA version 6.1 at the beginning of September 2003. The next version will be MedDRA 7.0 scheduled for the beginning of March 2004. The Board had heard a report from the MedDRA Maintenance and Support Services Organization (MSSO) about its subscriber statistics and activities, as well as a report of the MedDRA Japanese Maintenance Organization (JMO) activities in Japan, which shows an increasing number of subscribers. The Board was briefed on a number of activities within the U.S. Government regarding various standards initiatives associated with the electronic patient record and information exchange. The Board also heard a report from the joint MSSO-CIOMS Working Group for Standardized MedDRA Queries (SMQs).

The Global Cooperation Group (GCG) informed the Steering Committee about the outcome of their fruitful meeting on July 15th, 2003, where they were joined by representatives of four non-ICH regional harmonisation initiatives. Participants agreed the detailed programme of the Satellite Session on "Partnerships in Harmonization" on Wednesday November 12, 2003, at the ICH6 Conference in Osaka, and also discussed potential greater areas of collaboration or interaction in the future.

For further information, please contact:

ICH Secretariat (c/o IFPMA) 30, rue de St.Jean, PO Box 758, 1211 Genève 13, Switzerland

Tel : +41 (22) 338 3206 Email: ich@ifpma.org

Fax : +41 (22) 338 3230 Web site: www.ich.org

Date Created: September 3, 2003