完整申请(Full application)即是按照欧盟指令2001/83/EC中Article 8(3)的要求进行的申请,包含独立申请和混合申请2种方式。独立申请(Stand-alone application),即指的是需提供充分完整的药学、临床前和临床研究数据以证明药品的质量、安全性和有效性的完整申请,这些数据均是通过对药品进行研究产生的数据。混合申请(Mixed...
Canary provides Product Development and Global Regulatory Affairs strategic advice and operational support to the Pharmaceutical, Biotechnology and Medical Devices sectors to expedite registration and commercialisation.
Michelle Mazuranic, Head of Global Medical Affairs, Gan & Lee. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining market approval. Orphan drug designation in the European Union (EU...