ICH Tallinn Press Release - IPQ

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
PRESS RELEASE
Tallinn, Estonia, 10 June, 2010
"Implementing the new Quality Paradigm"
The International Conference on Harmonisation (ICH) Steering Committee and its Expert
Working Groups (EWGs) met in Tallinn, Estonia from 5 – 10 June, 2010. The main achievements
are outlined below.
Quality of Pharmaceuticals
This meeting was highlighted by major progress in the global implementation of the ICH
Guidelines Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) and Q10
(Pharmaceutical Quality System) in an integrated way. To this end the ICH Quality Implementation
Working Group (IWG) held its first training workshop in Tallinn. The training consisted of a case
study representing the different phases of the life cycle of a pharmaceutical product. The case
study was followed by individual break-out sessions on design space, control strategy, quality risk
management and pharmaceutical quality system. The workshop was appreciated by the 240
participants from 34 countries, with 100 assessors and inspectors from 32 different health
authorities and 140 industry experts representing 45 companies. The training will also be held in
the other two ICH regions, with the next workshop in Washington, D.C. on 6-8 October 2010,
followed by Tokyo on 25-27 October 2010.
Further progress was made on the harmonisation of pharmacopeial text in the three regions, which
will reduce testing requirements for industry. Two annexes for the Q4B Guideline (Evaluation
and Recommendation of Pharmacopoeial Text for Use in the ICH Regions; Annex 11 on
Capillary Electrophoresis and Annex 12 on Analytical Sieving) reached Step 4 and another 2
(Annex 13 on Bulk and Tapped Density and Annex 14 on Bacterial Endotoxin) reached Step 2.
The Q3D EWG began work on a guideline that will provide limits on Metal Impurities
qualitatively and quantitatively in drug products and ingredients.
Non-Clinical Safety
The ICH Steering Committee approved the establishment of an EWG for a new multidisciplinary
topic (M7) on Genotoxic Impurities. The guideline will describe the evaluation, qualification and
control of these impurities in medicines during development and after licensing.
The Steering Committee also approved the establishment of an EWG for a new safety topic on
Photosafety Evaluation (S10). The aim is to provide harmonised guidance on timing and
appropriateness of photosafety testing and assessment.
A workshop on in vitro models for reproduction toxicity discussed the impact of the EU research
project ReProTect on future approaches for reproductive toxicity studies. The ReProTect project
develops a novel approach in hazard and risk assessment of reproductive toxicity, by a
combination and application of in vitro, tissue and sensor technologies.
Clinical Safety and Efficacy
The E7 IWG completed a set of Questions and Answers (Q&As), addressing issues arising from
the E7 guideline on Studies in Support of Special Populations: Geriatrics. The Q&As provide
guidance on the appropriate representation of the geriatric population (including patients with
concomitant therapies and co-morbidities) in the clinical development program to adequately
characterise efficacy and safety in the geriatric population.
ICH Secretariat c/o IFPMA, Chemin Louis-Dunant 15, P.O. Box 195, 1211 Geneva 20, Switzerland
Telephone: +41 (22) 338 32 06 Telefax: +41 (22) 338 32 30
E-mail: admin@ich.org Web site : http://www.ich.org

The next ICH Steering Committee and its expert working groups meetings will be held in
Fukuoka, Japan from 6-11 November, 2010.
Notes
1. For the agenda and registration to the integrated implementation training workshop for ICH
Q8, Q9 & Q10 in Washington, D.C. on 6-8 in October 2010 and in Tokyo on 25-27 October
2010 see here:
http://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/European-
Events/ICH-Q-IWG.aspx
For further information, please contact:
ICH Secretariat, c/o IFPMA, 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
Web site: www.ich.org