-
Glossary
SADC
South African Development Community, and one of the Regional Harmonisation Initiatives (RHIs)
Step Process
The formal ICH procedure consists of 5 Steps: Step 1: Consensus Building, Step 2: Confirmation of six-party consensus, Step 3: Regulatory Consultation and Discussion, Step 4: Adoption of an ICH Harmonised Tripartite Guideline, Step 5: Implementation