苏州自贸片区创新监管模式,推动医药产业集约化精益化发展
Su Zhou Ri Bao·2025-10-31 23:07

Core Insights - The Suzhou Free Trade Zone has initiated a pilot program for optimizing warehousing resources among group pharmaceutical enterprises, aiming to innovate regulatory models and stimulate high-quality development in the pharmaceutical industry [1][2] Group 1: Pilot Program Details - The pilot program is a collaboration between the Suzhou Industrial Park Market Supervision Bureau and the Jiangsu Provincial Drug Administration, focusing on legal frameworks, policy boundaries, and implementation pathways for group pharmaceutical enterprises [1] - The program allows pharmaceutical production and wholesale enterprises within the same group to share or integrate warehousing facilities, provided they meet compliance conditions, breaking down previous operational silos [1] - A unified standard for warehousing management has been established, ensuring compliance with the Drug Administration Law and related regulations, with companies being held accountable for drug quality and safety [1] Group 2: Initial Outcomes - Two companies have already qualified for the pilot, demonstrating initial success in optimizing internal assets, reducing redundant warehousing construction, and significantly lowering fixed asset investments and logistics management costs [1] - The internal flow of pharmaceuticals has been streamlined, enhancing logistics efficiency and promoting a more intensive and lean development direction for the pharmaceutical industry [1] Group 3: Future Directions - The pilot represents a significant breakthrough in regulatory innovation for the pharmaceutical sector, providing a "Suzhou solution" to reconcile industry development with regulatory practices [2] - The market supervision bureau plans to conduct one-on-one follow-up guidance for pilot enterprises to address challenges in policy implementation [2]