The Pharmacopoeia of People's Republic of China 2015 Edition ( hereinafter referred to as the “ Chinese Pharmacopoeia") has been drafted under the joint efforts of all members of the Tenth Pharmacopoeia Commission and the staff of its Permanent Institution. It has been the 10th edition of Chinese Pharmacopoeia since it was firstly published in 1953. In accordance with the Decree of No.6 [2015] of the China Food and Drug Administration (CFDA), the Chinese Pharmacopoeia 2015 Edition will come into effect as of December 1 of the same year, and it has been published exclusively by the China Medical Science Press in August 2015.
The Chinese Pharmacopoeia sets the standards and codes to ensure drug quality and safe usage by public. It is also the statutory basis that must be strictly abided by drug manufacturers in the development, manufacturing, operation, consumption and management of pharmaceutical products. It is the core of Chinese national drug standards, the most serious and authoritative drug standards.
This edition of pharmacopoeia comprises of Volume I, II, III and IV, containing 5,608 monographs and 1,082 new monographs, 23.7% more in total than the last edition. Volume I contains a total of 2,598 monographs of the prepared slices of Chinese crude drugs, vegetable oil fats and extracts, patent Traditional Chinese Medicines, and single-item preparations, and of which 440 are new monographs. Volume II has 492 new admissions of a total 2,603 monographs of chemical drugs, antibiotics, biochemical drugs and radiopharmaceuticals. Volume III contains a total of 137 biological products, of which 13 are new monographs. With the consolidation of the general notices (appendices) of the previous edition, including the supplements and revision of medical exipients, the general requirements and medical exipients become the independent Volume VI. In total Volume IV contains 317 general requirements and 270 pharmaceutical excipients.
The 2015 edition of Chinese Pharmacopeia, serving to ensure the drug quality and adhering to maintaining scientific, advanced, and authorative nature of the previous edition, focuses on addressing the outstanding issues of drug safety and efficacy, enhancing the standard-based quality control of drugs, learning from the advanced technologies and experiences from around the globe, and reflecting the current capabilities of the Chinese pharmaceutical industry, clinical medication and testing technologies. It will play an important role in enhancing drug quality within China and further increasing the international influence of Chinese pharmacopoeia, capabilities of the Chinese pharmaceutical industry, clinical medication and testing technologies. It will play an important role in enhancing drug quality within China and further increasing the international influence of Chinese pharmacopoeia.
This edition of pharmacopoeia is characterized by the following features:
(1) The number of monographs has been greatly/significantly increased.
(2) The pharmacopoeia standards have been more systematic and standardized.
(3) The overall quality has been improved significantly.
(4) The standards for pharmaceutical excipients have been raised significantly.
(5) The pharmacopoeia now provides even stronger industry guidance.
(6) The pharmacopoeia now wields even greater international influence
