The new pharmacopoeia has been promulgated. There are two points that pharmaceutical companies must know

Source: the 2015 edition of Chinese Pharmacopoeia, which was brewed for 5 years from June 30, 2015 by medical observer network / Lu Liqiang, was finally published On the whole, the changes are obvious, but there are not many innovations, among which the relevant provisions of excipients are of concern Under the new edition of Pharmacopoeia, the level of pharmaceutical industry and supervision in China will be improved, and the current and future pharmaceutical standards will become a powerful tool for market competition There is improvement and less innovation in 2015 version of Chinese Pharmacopoeia, which is expected by the industry for a long time As an important policy and regulation reflecting the pharmaceutical level in China, the new pharmacopoeia has been widely concerned It is understood that the 2015 edition of the Chinese pharmacopoeia is the tenth edition of the Pharmacopoeia published and implemented in China since the first edition of the pharmacopoeia in 1953, which is basically revised and published once every five years According to the past version, the newly issued 2015 edition Pharmacopoeia clearly shows that the control requirements of safety and effectiveness of drugs are greatly enhanced and strengthened on the basis of the original scientific, normative and advanced nature, and the requirements are more specific, more operable, more feasible, and more capable of supervision Yang Tao, a special observer of this newspaper and pharmaceutical enterprise management consultant of Rito Enterprise Management Consulting Co., Ltd., said that the most intuitive change of the new pharmacopoeia is that the original three parts have been changed into four parts, and the appendix and auxiliary materials have been separated into one part According to 2015 The ultimate goal of the Chinese pharmacopoeia is to further improve the structure of the Chinese Pharmacopoeia after five years of efforts, to collect varieties to meet the needs of the national essential drug catalog, national basic medical insurance, work injury insurance and maternity insurance, to further improve the level of drug safety assurance and quality control, to lead the international development of traditional Chinese medicine standards, and to develop chemical and biological products The standard meets or approaches the international standard, the national drug standard system with Chinese Pharmacopoeia as the core is more perfect, and plays a greater role in guiding the technological progress and structural optimization and upgrading of the pharmaceutical industry At present, the new medical reform has entered the deep-water area, and various policies have been promoted successively The entire pharmaceutical industry is in a critical period of transformation and upgrading The 2015 edition of Chinese Pharmacopoeia issued at this special node will play an important role in the development and promotion of the industry In fact, each edition of Chinese Pharmacopoeia has its historical mission in different periods It can be seen that, on the one hand, the 2015 edition of Chinese pharmacopoeia is closely linked with the current medical reform to ensure the quality and safety of basic drugs, medical insurance and other products, on the other hand, it is in line with the international frontier to achieve the overall improvement of drug standards Finally, they all point to establish a perfect and high-level drug quality standard system In Yang Tao's view, the 2015 Pharmacopoeia, drawing on the international advanced quality control technology and experience, and integrating the independent innovation and experience of China, has improved the standard level of the Pharmacopoeia as a whole, but the innovation of the 2015 pharmacopoeia is not strictly speaking, just adding up what should have been For example, the limit standards for sulfur dioxide residues in Chinese herbal medicines and pieces of decoction have been increased, the limit standards for the detection of heavy metals and harmful elements, aflatoxin, pesticide residues and other substances have been improved, and the control of heavy metals and toxic and harmful substances in Chinese herbal medicines has been strengthened These should have been controlled for a long time One of the main obstacles to the export of traditional Chinese medicine is that the content of heavy metals and pesticide residues exceed the standard For example, the qualitative and quantitative determination methods of impurities have been strengthened, which ensures the stability of drug quality and the safety and effectiveness of drugs These requirements are not innovative content, because DMF is applied for export approval This is required for files "From the perspective of pharmaceutical enterprises, if the national supervision can continue to strengthen and make a difference, the most noteworthy thing should be the gap between the actual production of enterprises and the Pharmacopoeia standards This gap is not only the gap between the test results and the test methods and the provisions of the Pharmacopoeia, but also whether there is a gap in the whole system." Yang Tao further analyzed that traditional Chinese medicine enterprises must pay attention to the limit control of detection of sulfur dioxide, heavy metals, pesticide residues, etc.; chemical pharmaceutical enterprises must pay attention to the research of qualitative and quantitative determination methods of impurities, which must be supplemented In the 2015 Pharmacopoeia, the relevant provisions on pharmaceutical excipients are important changes, including the increase of excipients and the independent roll formation of excipients, which shows that the state attaches great importance to pharmaceutical excipients Yang Tao said that the management of pharmaceutical excipients in China has always been a weak link in supervision, but the stability, safety and absorption of pharmaceuticals are closely related to excipients The industry often heard that why enterprises and Pfizer and other multinational pharmaceutical enterprises use the same manufacturer's Azithromycin raw materials, and the effect of azithromycin tablets is different, which is the reason for excipients It must be an important one In fact, the main problems of auxiliary materials in China are "small, scattered and disorderly" These enterprises do not have strong R & D capacity, weak technology, small scale, poor conditions and lack of quality management system Moreover, the state does not pay enough attention to the auxiliary material enterprises and the supervision is not effective Even if the supervision is inadequate, it is often difficult to achieve results due to the lack of national perfect standards and measures "Because the inspection of excipients is not focused on in the supervision of preparations in China, in order to reduce costs, enterprises will drill holes and use the excipients produced by unqualified enterprises to replace pharmaceutical excipients." Yang Tao said that Chinese pharmaceutical excipients enterprises must work hard to improve themselves in terms of research and development, technology and quality, and clearly realize that pharmaceutical excipients are a part of drugs, which is of great importance Compared with excipients, pharmaceutical standards are more worthy of attention for pharmaceutical enterprises In every new pharmacopoeia formulation, some pharmaceutical enterprises will become the drafter or participant of a certain drug quality standard, and become the drafter or participant of the standard, which obviously has many advantages for enterprises Third class enterprises sell products, second class enterprises sell brands, and first-class enterprises set standards and rules There is no harm and it is necessary for enterprises to participate in the development of standards Only the original research enterprise is qualified to develop a patent innovative drug after it is developed Other people have no way to develop it Of course, for the promotion of some old drug standards, every enterprise has the right to do Research on the promotion of standards, depending on whether the enterprise has the ability Yang Tao pointed out this point more bluntly: enterprises participating in the formulation of drug standards, just like participating in the formulation of game rules, not only have a deeper and thorough understanding of this standard, but also the standards formulated are based on the actual situation of their own enterprises After the establishment of the standard, other enterprises must make more efforts to meet this standard, or even have to re study it, which is time-consuming and laborious, and increase investment In addition, it is pointed out that the new pharmacopoeia may have an impact on the market trend of some varieties In fact, according to the past experience, the implementation of Pharmacopoeia will not have a great impact on the market However, we need to pay attention to the fact that Pharmacopoeia has become the most important policy document in drug regulation of various countries With the update of Pharmacopoeia, its future role will be further reflected "It is hoped that in five years' time, the 2020 edition of Chinese Pharmacopoeia issued by the state will be more comprehensive, specific, instructive and operational." Yang Tao believes that only in this way can we really improve the level of pharmaceutical industry and supervision, and then enhance the overall competitiveness of the pharmaceutical industry in China.