110M population1.1 億人口Largest Arab market阿拉伯世界最大EU-modelled rules法規仿歐盟
The largest Arabic-speaking market, and a bridge into both MENA and East Africa. Its rules follow the EU, so our technical files transfer with little rework.阿拉伯世界人口最多的市場,也是通往中東北非與東非的橋樑。法規仿歐盟,我們的技術文件幾乎可直接沿用。
- Products must be notified to the Egyptian Drug Authority (EDA) and assigned a notification number — without it, import is not legal產品須向埃及藥品管理局(EDA)通報並取得通報號——沒有通報號不得合法進口
- The framework is largely modelled on the EU, so PIF and safety-assessment content carries over法規體系大致仿歐盟,PIF 與安全評估內容可直接沿用
- Arabic labelling is required阿拉伯語標籤為強制要求
Recommended partnership建議合作模式: Regional agent區域代理