Introduction of the Main Content of the General Notices in the European Pharmacopoeia

OBJECTIVE To introduce the main and changing content of the General Notices in the 11.0 edition of European Pharmacopoeia compared with the 10.0 edition, and to compare and analyze the content with reference significance.

METHODS To compare the layout structure and main content of the General Notices in the 11.0 edition of European Pharmacopoeia with the 10.0 edition, and to comment on changes and key content of the 11.0 edition of General Notices.

RESULTS Compared with the 10.0 edition, the layout structure and content of the 11.0 edition of General Notices had changed significantly. And it supplemented the contents of demonstration of suitability of monographs, general monographs and general monographs on dosage forms, monographs on herbal drugs, monographs on medicinal active substance, etc. Furthermore, it normalized some definitions.

CONCLUSION The layout structure of the new version of the General Notices is more clear, the content is more rigorous and comprehensive, and it has guiding significance for the implementation of European Pharmacopoeia, and can be used as reference for the revision of the General Notices in the Chinese Pharmacopoeia.