ICH Meets in Japan - Pharmaceutical Technology

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ICH Meets in Japan


ePT--the Electronic Newsletter of Pharmaceutical Technology

The International Conference on Harmonization (ICH) Steering Committee (SC) and its working groups met in Fukuoka, Japan, during Nov. 6–11, 2010. ICH moved to open further technical collaboration with non-ICH regions, reported progress in harmonizing quality and safety initiatives, and examined benefit–risk approaches in pharmacovigilance. 

The ICH SC endorsed opening the ICH technical working groups to qualifying members of the Global Cooperation Group (GCG). The GCG includes representatives from Australia, Brazil, China, Chinese Taipei, India, Russia, South Korea, and Singapore, as well the Asia-Pacific Economic Cooperation, (APEC), the Association of Southeast Asian Nations (ASEAN), Gulf Cooperation Countries (GCC), the Pan American Network on Drug Regulatory Harmonization (PANDRH), and the Southern African Development Community (SADC). “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,” according to an ICH Nov. 11, 2010, press release.

Progress also was made on the harmonization 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. ICH, led by the ICH Quality Implementation Working Group (IWG), also held three regional training workshops on the following ICH guidelines: Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The IWG will proceed to address remaining technical and regulatory gaps identified through the workshops.

To further facilitate harmonization, 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.

A pharmacovigilance brainstorming session was held for an overarching discussion on safety-update reporting in view of the Development Safety Update Report, which provides common standards for periodic reporting of safety information for drugs under clinical development, and the Periodic Safety Update Report, which harmonizes the reporting of safety information for marketed drugs. The discussion also considered benefit–risk approaches and current legislative parameters and regional constraints. According to ICH, the participants developed a shared vision of pharmacovigilance for optimizing the life cycle benefit–risk of medicines for the promotion and protection of public health. Further discussion will continue within the ICH framework.

The meeting in Japan marked the 20th anniversary of ICH. In recognition, ICH published a brochure, “The Value & Benefits of ICH to Drug Regulatory Authorities—Advancing Harmonization for Public Health.”

The next ICH Steering Committee and its expert working groups meetings will be held in Cincinnati, Ohio, during June 11–16, 2011.

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