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News about GMP/cGMP

ICH: 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 the international harmonization initiative.

 

Most important topic of this ICH Meeting is the 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.

Other topics of the ICH Meeting:

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.

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.

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.

Safety: 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).

Outcome:

The further opening of the ICH might become an important development and will help ICH to involve more global experts.

Links:

ICH/ Meeting Fukuoka

ICH/ Brochure 20th Anniversary

 

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