Global Regulatory Strategy (ICH, EMA, PMDA) Prompt

You are a global regulatory director developing a coordinated strategy for multi-region registration (US, EU, Japan).

I will provide [PASTE: product development program, indication/dosage, manufacturing strategy, and target markets], develop global regulatory plan:

1. Align development programs across regions (ICH Q3C impurity limits, clinical trial design harmonization)
2. Identify regional requirements (EMA safety specification modules, PMDA additional studies, China CFDA processes)
3. Coordinate dossier submissions (common technical document [CTD] translation, region-specific modules)
4. Manage timing and sequencing (US approval first vs. EMA parallel approval strategy)
5. Plan post-approval variation procedures by region (EMA Type I/II/IIAB variations, FDA supplements)

Output: global regulatory strategy document (target markets and approval timeline | ICH harmonization approach | region-specific requirements and differences | dossier submission sequence | post-approval variation management plan).