The IPEC Federation has released the IPEC Significant Change Guide  (Version 5, 2023), which is now publicly available worldwide.IPEC China has completed the Chinese translation and officially launched it for members to download.

The new version of the guidelines has not undergone significant changes in content compared to the 2014 version, but it is more in line with the policy and format requirements of the IPEC General Guidelines. The new version of the guide has unified the terminology and general statements in the text, adjusted some content to more relevant chapters, and a major highlight is the integration of decision trees into the corresponding sections of the main text, making it easier for readers to understand and refer to.

The Chinese translation of this guide has received strong support from IPEC China member volunteers. We would like to express our gratitude to the members of the working group for their time and contribution to the translation and proofreading of this guide. We also appreciate the support provided by the member employers to ensure the smooth completion of the work. (Ranked in no particular order)

Martin Tao (Roquette)
Doretthe Dong(Kerry)
Sunny Chen (JRS)
Elly Song (Dow)
Florence Xu (Colorcon)
Henry Wang (Clariant)
Li Chunhong (Suzhou Capsule)
Li Na (Clariant)
Bree Wang (Merck)
Cissy Wang(Ashland)
Vivian Yang (Colorcon)
Shine Gao(Ingredion)

*Copyright © Copyright of this guide and its Chinese translation from The International Pharmaceutical Excipients Council (IPEC) owns it.

Click on "Read Original Text" in the bottom left corner to enter>Home>Resource Download>IPEC Guide, log in to your member account to download Chinese translation of the IPEC Guidelines for Major Changes in Medicinal Excipients (5th edition, 2023).

For more information, please contact the IPEC China Secretariat,E-mail info@ipec-china.org