Progress on Pharmacopeial Discussion Group Standards for Pharmaceutical Excipients and its Enlightenment to Chinese Pharmacopoeia

OBJECTIVE To explore the ideas and methods of international harmonization of the Chinese Pharmacopoeia, drawing on the experience of the pharmacopeial discussion group(PDG) on the harmonization standards for pharmaceutical excipients in the European Pharmacopoeia, the United States Pharmacopeia and the Japanese Pharmacopoeia. METHODS By reviewing the PDG working background, procedures, and progress, analyze the characteristics of harmonization standards, and sorted out the similarities and differences between the harmonization standards and the Chinese Pharmacopoeia for pharmaceutical excipients. RESULTS The corresponding standards for pharmaceutical excipients in the Chinese Pharmacopoeia(2020 edition) volume Ⅳ had a certain advancement, and still need to be further improved. CONCLUSION It is recommended that Chinese Pharmacopoeia Commission strengthen the connection with PDG, combine the national conditions of China, clarify the principles of standards harmonization, improve the level of pharmaceutical excipients standards, and steadily promote the progress of the international harmonization standards of pharmaceutical excipients.