At its meeting in November, ICH cleared its Q12 draft guideline on life cycle management for the public comment phase (Step 2b). The comment period will be 12 months, through December 2018. Among other decisions, the ICH Assembly approved the Health Sciences Authority, Singapore (HSA), as a new Regulatory Member. The Assembly also approved the Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Colombia (INVIMA), and the Bill & Melinda Gates Foundation as new Observers. With these new parties, there are now 15 members and 24 observers.
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