International Technical Requirements for Medicinal Product Registration

Author: ICH Guiding Committee
Publisher:
Publishing Date: 2001-06-01
Features: With the continuous deepening of China's reform and opening-up, as well as the constant improvement of pharmaceutical research and development levels, China's drug supervision and management work must gradually align with international standards. Since its establishment over two years ago, the National Supervision Administration has been working hard to build a "supervision based on law, scientific evaluation, integrity and efficiency, and standardized conduct" drug supervision and management system. In this context, the translation of all ICH guidelines and their compilation into a published volume will help pharmaceutical researchers and management personnel understand the latest advancements in technical requirements for international drug research and development, thereby improving China's drug development level, enabling Chinese drugs to better enter the international market, and making the contribution to the health of people worldwide. The entire book is presented in a bilingual Chinese-English format, accompanied by a Chinese-English glossary. It is the first complete Chinese translation of ICH guidelines in China.