In August 29th, the eleventh Pharmacopoeia Committee was established and the general committee meeting was held in Beijing. The preparation of the 2020 edition of the Chinese Pharmacopoeia was held at the meeting. The reporter learned that, in considering the overall situation of national drug standards based on the 2020 edition of "Pharmacopoeia" is expected to Chinese contained about 6400 new varieties, 800 varieties, varieties accounted for 12.5% of the total. 1400 varieties were revised, accounting for 21.9%.

New pharmacopoeia embodies reform results

Bi Jingquan, director of the State Food and drug administration, pointed out in his speech that the drug administration law clearly defined the statutory status of the drug standards and the statutory functions of the Pharmacopoeia Commission, and produced a version of the Pharmacopoeia every five years. So far, China has promulgated and implemented the ten edition of Pharmacopoeia, the drug standard contained varieties from scratch, from less to more, from low to high standards, to improve our overall quality level, promote the pharmaceutical pharmaceutical industry transformation and upgrading has played an important role.

He stressed that the basic standard for drug listing is that new drugs should be global, and that generic drugs should be consistent with the quality and effectiveness of the original medicines". The new edition of pharmacopoeia is in a critical period of reform, and there will be many changes. Pharmacopoeia preparation work should implement the Central Committee of the CPC and the State Council on drug review and approval, drug supervision and reform of a series of requirements, reflecting the results of the reform, the quality of drugs, the improvement of efficacy should be promptly reflected in the pharmacopoeia.

Preparation work eight specific tasks

At the meeting, Zhang Wei, Secretary General of the national pharmacopoeia commission, introduced the outline of the Chinese Pharmacopoeia 2020 edition. He pointed out that there were eight specific tasks for the work of the organization:

First, a moderate increase in the collection of varieties, to further meet the clinical needs. After a substantial increase in the variety of the calendar edition Pharmacopoeia, the current edition of Pharmacopoeia reached the full coverage of essential drugs, medical insurance drugs, and can meet the needs of clinical medication. In 2020, the Pharmacopoeia put forward the appropriate growth of varieties, including the adjustment of the catalogue, and the two, the keynote of the work, from the quantity of the drugs in charge to the improvement of the internal quality of drugs;

Two is to clean up with the national drug standards, and gradually improve the drug standard elimination mechanism. The establishment of the national drug standard elimination mechanism, standard "into a" standard, increase efforts to eliminate the cancellation number, long-term production, quality control, dosage form is not reasonable and the stability of the drug standard "subtraction";

Three is to improve the "Chinese Pharmacopoeia" standard system, strengthen the whole process of drug quality management concept. Improve and enrich the connotation of drug standards, and strengthen the process control, from the terminal control of drugs to the process of production and control of the source of extension, and realize the quality control standard system of life cycle of drugs;

Four is to strengthen the "Chinese Pharmacopoeia" normative, including the ministries Pharmacopoeia, general technical requirements and the unification of the various standards. Referring to the international model, we should improve the writing format and style of the various Pharmacopoeia theories, and establish a unified and standardized drug, medical excipients and medicinal materials, such as the general name and nomenclature;

Five is to improve the generic technical requirements, and comprehensively display the level of drug quality control. The 2020 edition of the Pharmacopoeia focuses on strengthening the research and establishment of drug safety and effectiveness control methods. Strengthening the application of advanced detection technology in drug quality control;

Six is to promote the harmonization of paper standards and physical standards. Physical standards are the standard of drug standards. In the process of drafting standards research, we should do a good job of linking standard work, actively screening and recommending standard candidates, and striving for the simultaneous introduction of standards and standard products;

Seven is to strengthen international exchange and cooperation of drug standards, and promote international coordination of Pharmacopoeia standards. Coordinate standard coordination with the import and export trade demand of pharmaceuticals. Highlight the international dominance of Chinese medicine standards, and constantly expand the international influence of the Chinese Pharmacopoeia and the quality of Chinese medicines;

Eight is to strengthen the pharmacopoeia standard information construction, and constantly enrich the standard form of service. At the same time of publishing the paper edition, the simultaneous release of electronic edition, mobile edition and network version will speed up the construction of the standard information service platform of Chinese Pharmacopoeia, and further enhance the social service function of the pharmacopoeia.

The reporter also learned that at the meeting, in the past fifteen years, China's rapid development of the pharmaceutical industry and the gradual transition period, China is gradually to the generic drugs by combining imitation and creation into the period, especially the implementation of major drug created special, so that the new drug R & D capacity has been significantly improved. In order to meet the clinical needs, to protect essential drugs and medical insurance drugs, a large number of new varieties of income, the Chinese pharmacopoeia. The new analysis technology and detection method are widely used in the quality control of drugs, effectively improving the quality control of drugs and ensuring the public use of drugs. However, China's pharmaceutical industry enterprises, wide distribution, production conditions, product quality difference, uneven quality control technology is relatively backward situation still exists, especially Chinese herbal medicine and herbal pieces, the quality problem is still outstanding, Pharmacopoeia standards is still an arduous task and challenge.