On August 29, 2008, the 11th annual pharmacopoeia committee was held in Beijing, and the 2020 edition of the China pharmacopoeia was deployed. The reporter learned that, on the basis of considering the overall state drug standards, the China pharmacopoeia of 2020 is expected to receive about 6,400 varieties and 800 additional varieties, accounting for 12.5% of the total number of varieties. The revised variety was 1,400, accounting for 21.9%.
The new edition of pharmacopoeia embodies the results of reform
Jingquan, head of the national food and drug supervision and administration bureau, in his speech, pointed out that the pharmaceutical administration law made clear the legal status of the drug standards and the legal responsibilities of the pharmacopoeia committee, prepare a version pharmacopoeia every five years. So far, China has enacted the ten version pharmacopoeia, from scratch, contains standardized medicines from less to more, standard level from low to high, to overall improve the level of drug quality in our country, promote the transformation and upgrading of the pharmaceutical industry has played an important role.
"The basic standard for drug listing is that new drugs need to be globally new," he said. "generic drugs should be consistent with the quality of the original drug." The new edition of the pharmacopoeia is in a critical period of reform and there will be many changes. Pharmacopoeia preparation work to implement the party central committee and state council on drug approval for examination and approval, drug regulatory reform in a series of requirements, reflect the achievements of the reform, improve the efficacy of drug quality to timely reflect in the pharmacopoeia.
To prepare eight specific tasks
At the meeting, zhang wei, secretary general of the national pharmacopoeia commission, introduced the outline of China's pharmacopoeia in 2020. He pointed out that there were eight specific tasks for the preparation:
The first is to increase the collection of varieties appropriately and further meet the clinical needs. After a large increase in the number of drug offerings, the current pharmacopoeia has reached the basic drug and the coverage of medical insurance, which can adapt to the needs of clinical medicine. The 2020 edition of the pharmacopoeia has proposed a moderate increase in the number of varieties, one is to consider the adjustment of the contents, the second is to focus on the number of drug collection and the improvement of the intrinsic quality of drugs.
Second, we will gradually improve the elimination mechanism of drug standards in combination with national drug standards. To establish the national drug standard elimination mechanism, the standard will "have to have a", intensify standard out, to have to cancel the approval document, long-term don't production, quality control, dosage form is not reasonable, the stability is not high pharmaceutical standards of "subtraction";
Third, the concept of perfecting the standard system of Chinese pharmacopoeia and strengthening the whole management of drug quality. Improve and enrich the connotation of drug standards, strengthen process control, and control the extension of drug terminal control to the production process and source control, and realize the quality control standard system of drug life cycle;
Fourth, strengthen the standardization of the Chinese pharmacopoeia, including the unification of the technical requirements of various pharmacopoeia and the requirement of universality. In the light of the international model, we can improve the writing format and style of pharmacopoeia theory, and establish the common name naming principle of medicine, pharmaceutical auxiliary materials and medicine packaging materials.
Fifth, we will improve the general technical requirements and fully demonstrate the quality control of drugs. The work of the 2020 pharmacopoeia focuses on strengthening the research and establishment of control methods for drug safety and effectiveness. To strengthen the application of advanced detection technology in drug quality control;
Sixth, the promotion of the paper standard and the physical standard of coordination and unity. Physical standard is the standard drug standards, in the process of standard to study and draft completes the standard work of cohesion, active filtering, recommendation candidate, for standard and standard synchronous launch;
Seven is to strengthen international exchanges and cooperation in drug standards and promote international coordination of pharmacopoeia standards. Take the import and export trade requirement as the guide to carry out standard coordination work. To highlight the international dominance of traditional Chinese medicine standards, constantly expand the international influence of the Chinese pharmacopoeia and the quality of Chinese medicines;
The eighth is to strengthen the standard information construction of pharmacopoeia, and constantly enrich the standard service form. Published in the print edition at the same time, synchronous digital, mobile phone edition and online, to speed up the "Chinese pharmacopoeia" standard information service platform construction, further enhance the social service function of the pharmacopoeia.
Reporter also learned that at the meeting in the last 15 years, is our country medicine industry rapid development and the transition period, is our country drugs by gradually to imitation and the combination of war, especially the implementation of major drug discovery projects, new drug research and development capabilities have improved significantly in China. In order to meet clinical needs, basic drugs and medical insurance are guaranteed, and a large number of new varieties of Chinese pharmacopoeia. The new analytical techniques and detection methods are widely used in the quality control of drugs, which effectively improve the quality control of drugs and ensure the public use of drugs. But, our country medicine industry enterprises more, wide distribution, large difference of different production conditions, product quality, quality control technology such as relatively backward situation still exists, especially Chinese herbal medicine and yinpian, its quality problems still outstanding, pharmacopoeial standards is still a difficult task and challenge.
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