ICH – Press Release

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The International Conference on Harmonisation (ICH) Steering Committee and its expert working groups met in St. Louis, Missouri from October 24-29, 2009. The main achievements are outlined below.

This meeting was highlighted by progress made in the area of safety of pharmaceutical products. The S9 Guideline, “Non-clinical Evaluation of Anticancer Pharmaceuticals”
reached Step 4. This Guideline addresses non-clinical data requirements for pharmaceutical products intended to treat cancer in patients with late stage or advanced disease. The guideline aims to accelerate development and availability of drugs for these patients with unmet medical need while safeguarding patients’ safety. In addition, the S6 Guideline, “Revision of Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals” reached Step 2. This Guideline outlines a reduced duration and number of studies involving animals and could have a major impact on the use of animals in safety testing of pharmaceutical products. ICH remains committed to the “3 R’s” agenda, which is reducing/refining/replacing animal testing in the drafting of new or revision of existing guidelines.

In addition, ICH Safety experts participated in a one day “Safety Brainstorming Session” to discuss any current gaps in ICH safety guidelines and identified several potential  new topics.

There was major progress in the harmonization of pharmacopoeial texts in the three regions which will reduce testing requirements in the three regions. Three Annexes to the Q4B Guideline (Annex 7: Dissolution, Annex 9: Tablet Friability, and Annex 10: Polyacrylamide Gel Electrophoresis) reached Step 4 and another two (Annex 11: Capillary Electrophoresis and Annex 12: Analytical Sieving) reached Step 2. The ICH Quality Implementation Working Group is developing a training program for workshops that will be held in the three ICH regions that will cover the ICH Guidelines Q8, Q9 and Q10 with the aim of achieving globally consistent implementation of ICH
Guidelines Q8, Q9 and Q10. This training will consist of case studies representing the four phases of the life cycle of a pharmaceutical product. The workshops will be held in Brussels in June 2010, in Washington, D.C. in October 2010 and in Tokyo in November 2010.

The ICH gene therapy experts met to begin work on the 1st ICH Guideline on “Viral and Gene Therapy Vector Shedding and Transmission”.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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