中国食品药品监管Issue(8)：130-137,8.DOI:10.3969/j.issn.1673-5390.2025.08.015
跨国医药公司实施ICH指南的挑战与对策思考
Challenges and Countermeasures for Multinational Pharmaceutical Companies in Implementing ICH Guidelines
摘要
Abstract
With the deepening of globalization and the ongoing evolution of the pharmaceutical industry,frequent updates to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH)guidelines have had an increasingly significant impact on multinational pharmaceutical companies.These companies must closely monitor regulatory developments,promptly adjust business strategies and operational models,and ensure timely compliance with the evolving ICH requirements.This paper employs literature review and policy analysis methodologies to examine the key challenges faced by multinational pharmaceutical companies in implementing ICH guidelines,taking into account the historical development of ICH and corporate operational strategies.Furthermore,it proposes the construction of a general quality management framework adaptable across multinational operations to facilitate effective implementation of ICH standards.It is recommended that multinational pharmaceutical companies treat the adaptation to and implementation of updated ICH guidelines as a continuous strategic priority to maintain competitiveness in the global pharmaceutical market and achieve sustainable development.关键词
国际人用药品注册技术协调会指南/跨国医药公司/监管/挑战/策略Key words
ICH guidelines/multinational pharmaceutical companies/regulation/challenges/strategies分类
管理科学引用本文复制引用
史宇航,梁毅..跨国医药公司实施ICH指南的挑战与对策思考[J].中国食品药品监管,2025,(8):130-137,8.
