On June 8th, 20 15, the press conference of People's Republic of China (PRC) Pharmacopoeia (20 15) was held in Beijing, and the Pharmacopoeia was promulgated by China Food and Drug Administration.

The 20 15 edition of Pharmacopoeia is the 10 edition of Pharmacopoeia since the founding of New China. The 10th Edition Pharmacopoeia Committee was established in March of 20 10, and it took five years to compile the new Pharmacopoeia.

The 20 15 edition of Pharmacopoeia contains 5608 varieties, which is 1082 more than the 20 10 edition of Pharmacopoeia. It covers basic drugs, medical insurance catalogue varieties and commonly used clinical drugs, which is more suitable for clinical drug demand.

Moreover, the number of standards has been comprehensively improved, especially the control items around safety and effectiveness, and the detection items have been increased. Pharmacopoeia will be officially implemented from 20 15 12 1 ?

Extended content:

The main changes of China Pharmacopoeia 20 15 include the following seven aspects.

1, the number of varieties loaded increased greatly.

The 20 15 edition of the Pharmacopoeia contains 5924 varieties, with 1 125 new varieties and 120 1 revised varieties. The new version of Pharmacopoeia contains 5608 drugs, which is 1082 more than the 20 10 version of Pharmacopoeia, covering most varieties in the basic drug list and medical insurance list, and is more suitable for clinical use.

2. Pharmacopoeia standards are more systematic and standardized.

Through the comprehensive revision of the general principles, general rules and general remarks of Pharmacopoeia, the requirements of drug quality control have been further improved as a whole, the technical provisions of Pharmacopoeia standards have been improved, and Pharmacopoeia standards have become more systematic and standardized.

3. Improve the drug standard system.

The variety of pharmaceutical excipients has increased to 270, and relevant guiding principles have been added; New general rules and guiding principles for reference materials; New related guiding principles for pharmaceutical packaging materials; On the basis of induction, verification and standardization, the coordination and unification of detection methods in China Pharmacopoeia were realized.

4. Appendix (General) and independent volume of auxiliary materials-four parts.

One of the biggest changes in China Pharmacopoeia (version 20 15) is to integrate the appendices of the original Pharmacopoeia and make them into one volume independently from the standards of pharmaceutical excipients, which is the first time in the fourth part of China Pharmacopoeia. 2

Before version 0 10, every part of the pharmacopoeia was appended. Some of these appendix items have the same title and content, while others have the same title and different content. Through the integration, the problems of repeated inclusion, uncoordinated, inconsistent and irregular methods in various parts of Pharmacopoeia were solved, which brought inconvenience to the actual operation of drug inspection.

China Pharmacopoeia (version 20 15) includes four parts: exceptions, general rules and pharmaceutical excipients. After the integration of the general appendix, in addition to the general rules of biological products, the first and second parts no longer contain the general rules separately, but the general rules of special inspection methods for traditional Chinese medicine and biological products are listed separately.

5. The number of varieties of pharmaceutical excipients has increased significantly, and the standard level has improved significantly.

China Pharmacopoeia (20 15 edition) added 39 varieties of pharmaceutical excipients/kloc-0, revised 95 varieties, and collected 270 varieties.

The variety of excipients available for injection has been increased from 2 in version 20 10 to 23, and the standards for common excipients for injection such as polyethylene glycol 300, polyethylene glycol 400, polysorbate 80 and activated carbon have been added.

It plays an important role in improving the quality of pharmaceutical excipients, especially the safety of high-risk drugs, making up for the shortcomings of China's pharmaceutical excipients standards, improving the regulatory capacity of pharmaceutical excipients and promoting the development of pharmaceutical excipients industry.

6. The safety control project has been greatly improved.

Traditional Chinese Medicine: formulated the limit standard of sulfur dioxide residue in traditional Chinese medicine and decoction pieces, and promoted the establishment and improvement of the detection limit standard of heavy metals and harmful elements, aflatoxin, pesticide residues and other substances; Strengthen the control of heavy metals and toxic and harmful substances in Chinese herbal medicines.

Chemicals: related substances should strengthen the research on qualitative and quantitative determination methods of impurities, realize the differential control of known impurities and unknown impurities, optimize the determination methods of antibiotic polymers, set reasonable control limits, and further improve the scientificity and rationality of related substances as a whole.

Biological products: increase the requirements of relevant general instructions, strictly control the whole process quality of biological products, and ensure the safety and effectiveness of products. At the same time, update the General Technical Requirements for Quality Control of Raw Materials for Biological Products Production, strengthen source control, and minimize safety risks.

7. Further strengthen the effectiveness control.

The specificity identification and content determination of Chinese herbal medicines have been strengthened. The index of controlling the effectiveness of chemical drugs was appropriately increased, and a scientific and reasonable inspection method was established. Biological products further improve the standardization of efficacy test methods, strengthen the research and application of in vitro method instead of in vivo method, and ensure the accuracy and operability of efficacy test methods.

China Food and Drug Administration-People's Republic of China (PRC) Pharmacopoeia Edition 20 15 Press Conference