11 November 2010

ICH Looks Ahead to the Next Decade: Further Expansion to Non-ICH Regions

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its working groups met in Fukuoka, Japan from 6 - 11 November 2010. This meeting marked the 20 year anniversary of this highly successful international harmonization initiative.

Further Opening to Non-ICH Regions

The ICH SC endorsed the opening of the ICH technical working groups to the active participation of experts from qualifying members of the Global Cooperation Group (GCG). This represents a new level of involvement of the GCG and will provide an opportunity for direct technical contributions to the work of ICH, a more global perspective, and will advance implementation of ICH guidelines.

Celebration of the 20th Anniversary

ICH published a brochure entitled “The Value & Benefits of ICH to Drug Regulatory Authorities-Advancing Harmonisation for Public Health” in recognition of its 20th anniversary. This publication salutes two decades of the ICH’s groundbreaking work in harmonising drug regulatory requirements among global partners. A copy of the article is available on the ICH website.

Pharmacovigilance

A pharmacovigilance brainstorming session was held for an overarching discussion on safety update reporting in view of Development Safety Update Report (DSUR) and Periodic Safety Update Report (PSUR) as well as benefit/risk approaches and current legislative parameters and regional constraints. The participants developed a shared vision of pharmacovigilance aimed at optimising the lifecycle benefit/risk of medicines for the promotion and protection of public health. Further discussion will continue within the ICH framework.

Quality

Progress was made on the harmonisation of pharmacopoeial texts. The Annex 7(R2) on Dissolution Test for the ICH Q4B Guideline (Evaluation and Recommendation of Pharmacopoeial Text for Use in the ICH Regions) reached Step 4.

The three regional training workshops on the ICH Q8, Q9 and Q10 guidelines led by the ICH Quality Implementation Working Group (IWG) were well-attended and considered successful by both regulatory and industry participants. The IWG will proceed to address remaining technical /regulatory gaps identified through the workshops.

Safety

To facilitate further harmonisation, two new Expert Working Groups launched discussions on the ICH Guidelines M7 (Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk) and S10 (Photosafety Evaluation). In these initial meetings, productive discussions were held, and significant progress was made.

The next ICH Steering Committee and its expert working groups meetings will be held in Cincinnati, Ohio, USA from 11-16 June 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


[1] The GCG currently includes representatives from Australia, Brazil, China, Chinese Taipei, India, Russia, South Korea and Singapore, and other harmonisation initiatives, such as Asia-Pacific Economic Cooperation (APEC), Association of Southeast Asian Nations (ASEAN), Gulf Cooperation Countries (GCC), Pan American Network on Drug Regulatory Harmonization (PANDRH) and Southern African Development Community (SADC).