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
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Date created: September 3, 2003 |