18 June 2011

“ICH Global Expansion – Enhanced Scientific Exchanges”

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its working groups met in Cincinnati, Ohio from June 11-16, 2011.

Global Outreach Activities
For the first time, non-ICH regulators have been nominated to serve as experts in some quality, safety and efficacy expert working groups (EWGs). ICH welcomed the active participation of technical experts from China, Chinese Taipei, Korea and Singapore.

In efforts to further the global reach of ICH, the Global Cooperation Group (GCG) accepted the request of the East African Community (EAC) to join the other Regional Harmonization Initiatives in the GCG dialogue. The EAC is comprised of five countries: Kenya, Uganda, Tanzania, Rwanda and Burundi. In recent years, the EAC’s work on harmonization of medicines regulation has increased, and with the support of the World Health Organization, they have moved towards implementing many ICH guidelines, including the ICH Common Technical Document (CTD).

A group of global regulators who are cooperating in the area of cell therapy updated the ICH Steering Committee on their activities and reported that they are exploring potential areas for future harmonization or other approaches to regulatory convergence.

Quality Update
The Q11 draft Guideline, “Development and Manufacture of Drug Substances,” reached Step 2. This guideline describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided in a CTD. It provides further clarification on the principles and concepts described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance.

The Quality Implementation Working Group (IWG) completed three ‘Points to Consider’ documents on “Criticality of Quality Attributes and Process Parameters,” “Control Strategy,” and “Level of Documentation in Enhanced (QbD) Regulatory Submissions.” These documents will serve to provide supplementary information to the previously completed Q&A’s and training materials.

Safety Update
The S6(R1) EWG reached Step 4 on the Addendum to the S6 Guideline “Revision of Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.” The purpose of the addendum is to provide clarification of language in the original ICH S6 document regarding species selection, study design, immunogenicity, reproductive and developmental toxicity and carcinogenicity testing. The Addendum will be integrated in the core S6 Guideline which will be renamed S6(R1).

The M3(R2) IWG, “Guidance on Non-clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals” finalized three sets of questions and answers at Step 4 which address limit dose, reversibility of toxicity, and metabolites.

Efficacy Update
The E2B(R3) EWG “Revision of the Electronic Submission in Individual Case Safety Reports” progressed the E2B(R3) Implementation Guide (IG) to Step 2. This marks a significant milestone in that it is the first ICH work item to reach Step 2 under a pilot process that involved work in parallel with standards development organizations.

The next ICH Steering Committee meeting and its expert working groups will be held in Sevilla, Spain from November 5 – 10, 2011.

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

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