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Next Steps in WHOs Harmonization Efforts

In view of the decisions taken by ASEAN described below, WHO responded with the following action plan. First, a WHO document was circulated in early 2004, [Pg.51]

Revert to 30°C/70%RH as the long-term stability testing condition for Zone IV as it is likely that considerable data are already available. This might serve as a potential platform for future harmonization between ICH and WHO. [Pg.52]

Add a new climatic Zone IVB to accommodate hot and very humid areas (30°C/75% RH). The present Zone IV (30°C/65%RH) would become Zone IVA. [Pg.52]

Feedback was requested by end March 2005. WHO Member States not represented at the meeting were also invited to give their feedback. [Pg.52]




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