The new version of the Pharmacopoeia is about to implement the industry's accelerated shuffle
Release time: 2010-09-29 & nbsp & nbsp & nbsp Source:
A few days ago，2010 version of "China Pharmacopoeia" promotion and implementation conference was held in Beijing。2010 version of "Chinese Pharmacopoeia" is the 9th edition of Pharmacopoeia since the founding of New China，It will be implemented on October 1 this year，This indicates that the National Drug Standard Action Plan has achieved important stage results。
Sang Guowei, deputy chairman of the Standing Committee of the National People's Congress, pointed out at this meeting，2010 version of "Chinese Pharmacopoeia" was successfully promulgated and implemented，For improving the safety level of public medication，Enhance the international competitiveness of my country's pharmaceutical products，further promoting the adjustment of my country's pharmaceutical industry structure is of great significance。
According to the relevant person in charge of the National Pharmacopoeia Commission of China，This new version of the Pharmacopoeia is targeted at the total amount of varieties of the pharmacopoeia in my country、Elementary number of gates category，The new version of the Pharmacopoeia has further expanded the collection range，Basically formed Chinese medicinal materials、Traditional Chinese Medicine Drinking Film、Chinese Medicine、Chemicals、Medicinal Accessories、Biological products and other categories of categories are complete drug standard system。It is worth mentioning that it is，The content of the new version of the Pharmacopoeia has been adjusted: First, the newly promulgated national drug catalog is basically covered by the newly promulgated and implemented.。
The new version of Pharmacopoeia specially focuses on absorbing stake online sports bettingstake online sports bettingadvanced testing technologies and analysis methods at home and abroad，Put the ion chromatography、MRI and other new methods in drug quality analysis as a legal method for drug quality control，Receive into the attached record，This has become consistent with the international advanced level。The preparation and implementation of the new version of Pharmacopoeia，It also pays special attention to the standard systemic improvement problem，Not only does the loaded variety increased by more than 40%，and the original standard of 70%improves or improves，This means that the requirements for the quality control of listed drugs are becoming stricter and stricter。
Wu Yan, deputy director of the State Food and Drug Administration (SFDA), put forward specific requirements for implementing the 2010 version of "Chinese Pharmacopoeia": First, the promotion and training of the new version of the pharmacopoeia。It is understood，Current，The National Pharmacopoeia Commission and the Training Center of the State Food and Drug Administration have jointly held a 19 -phase Pharmacopoeia training course，Completed nearly 10,000 people training。
Second, it is necessary to strengthen the supervision and inspection of the implementation of the new version of the pharmacopoeia。Scientific Research Unit、Drug production and operation enterprises must fully understand the update and change of the new version of the pharmacopoeia，Actively organize and carry out equipment transformation and technology innovation，Make sure to develop、Production of qualified products that meet the new version of Pharmacopoeia; drug supervision departments at all levels must handle the administrative license matters proposed by the enterprise in accordance with the requirements of the new version of the pharmacopoeia，Increase the supervision and inspection of the execution of the new version of the pharmacopoeia; the health administrative departments at all levels must mobilize the majority of medical institutions，Determine the requirements of using the new version of Pharmacopoeia to collect medicines，Standardize the clinical application of drugs。
Third, continue to promote the continuous development of national drug standards。According to Wu Yan,，To further improve national drug standards，Promote better and faster development of the pharmaceutical industry，SFDA has put the preparation of the 2015 version of the Pharmacopoeia on the working day。
"Luofu Mountain" test
Since the state proposed the "Pharmaceutical Standard stake betting appMy stake betting appAction" plan in 2006，Related product standards involved in the compilation of the content of the new version of the pharmacopoeia，It is the specific content obtained by the participation of several domestic pharmaceutical companies，The National Pharmacopoeia Council writes the new version of the Pharmacopoeia based on these data and content directly from pharmaceutical companies。
Encouragement of active participation of these companies，At the implementation of the meeting on September 15，The National Pharmacopoeia Commission also commended 5 pharmaceutical companies participating in standard research and formulation in China。
"Study on the quality standards of anti -inflammatory biliary tablets with Luofu Yam, Guangdong，It can be seen。"At this meeting，A person in charge of the National Pharmacopoeia Commission said。It is reported，Guangdong Luofushan National Medicine Co., Ltd., due to its contribution and innovation of new standards and innovations in the new pharmacopoeia standards, became one of the 5 companies commended。
It is understood，A total of 11 contents of the new quality standards of anti -inflammatory bile tablets in the new version of Pharmacopoeia，Including regulating the method of system，Add film clothing tablets; delete chemical reactions for identifying items，Added a thin layer chromatography with strong dedicated properties、Immerse outlet inspection、Measurement of the content of wearing lotus dectide and dehydration and dehydrated lotion。Among them, the key one "wearing lotus dect ester content"，It has nearly 5 times higher than the original standard (the original standard contains 1mg，blockbuster 3mg; new standard is 5mg and 10mg)，so as to make the product quality and efficacy more guaranteed。
Deputy Secretary -General of the National Pharmacy Commission Zhou Focheng believes，Anti -inflammatory and bile tablets are the simpler varieties in the current existing Chinese medicine preparations，But the time that it enhances the standards in an all -round way、Energy and financial resources is still large。So，Other more complicated Chinese medicine compound preparations should be improved，Time spent、energy and financial resources will be greater。
"The state encourages enterprises to actively raise standards，It mainly includes three major aspects: First, we can issue proofs to the enterprise，Explain which company is the participation of this standard，Enterprises can display it in various fields，For example, the stake sports betting appstake online sports bettingapplication for scientific research projects、Special pricing of drugs。Second, all the varieties that have been used to the Pharmacopoeia，We will write it when we make a clinical drug instructions，Clinical medication is a doctor's case book，This is the free publicity for the enterprise。Three is after we compiled the medicine，Free publicity to foreign countries。In addition, in the selection of basic drug directory in the future、Selection of medical insurance directory，We will all call the country to select in the pharmacopoeia。This is the benefit of entering the new version of Pharmacopoeia。”
From the perspective of Xie Zhijie, director of the Guangdong Provincial Drug Inspection Institute，The active improvement standard of Luofu Mountain Chinese Medicine "knows very well、The investment is in place、improvement very well "，This will inevitably inject new core competitiveness into the development of the enterprise。
Industry reshuffle acceleration is inevitable
From the beginning of the formulation of the new version of the Pharmacopoeia，Almost all people in the industry said，"The new version of the pharmacopoeia greatly improves the quality of the pharmaceutical quality，On the one hand, it improved the core competitiveness of the development of pharmaceutical companies，At the same time, it will inevitably lead to a reshuffle of the domestic pharmaceutical industry，The market status of the superior enterprise will also be even more prominent。”
From January to June 2010, the pharmaceutical manufacturing industry still maintains a high growth rate，January-June Cumulative total output value of 547.628 billion yuan，increased by 25.99%year -on -year;，Made in Chinese patent medicine、Biological and biochemical drugs have a faster growth rate。
While growing at high speed，The pharmaceutical industry will face a big shuffle。According to industry insiders，2010 version of the Pharmacopoeia standard，It will cause some standards that do not meet the standard of enterprise products。Changes in the product structure，Change of corporate status。The implementation of the new version of the "Specification of Drug Operation Quality Management" (GSP)，It is bound to cause some certified companies to stop production and close the rectification。Accelerate the merger combination of the enterprise。In addition，The introduction of the "Twelfth Five -Year Plan" plan for the medical circulation industry，It may also cause integrated pharmaceutical business。
The person in charge of the National Pharmacy stake sports betting appstake online sports bettingCommission said，The introduction of the new standard of Pharmacopoeia，is the high standard of ensuring domestic drugs in the system，Guide enterprises to produce high -quality varieties，Guide grassroots use high -quality domestic drugs，Institution to ensure the revitalization of Chinese medicine。
This person in charge pointed out at the same time，There are many problems in the use and bidding of basic medication and bidding，There are many problems if there is no bidding for the bottom of the bid。One aspect，Make a number of manufacturers co -produced by the original price of low price，Bad in a cost bid in malignant bids，Drug prices deviate from its own value in the bid，As a result, the company only reduces production requirements，To ensure the market; on the other hand，Foreign -funded enterprises、Social venture and separate pricing varieties often win at high prices。"Drug varieties are reshuffled in the use of medical institutions: Popular drugs gradually disappear，A large use of imported drugs in medical institutions、Pharmaceuticals and high -priced medicines in bidding。”
Sang Guowei, deputy chairman of the Standing Committee of the National People's Congress, pointed out at this meeting，2010 version of "Chinese Pharmacopoeia" was successfully promulgated and implemented，For improving the safety level of public medication，Enhance the international competitiveness of my country's pharmaceutical products，further promoting the adjustment of my country's pharmaceutical industry structure is of great significance。
According to the relevant person in charge of the National Pharmacopoeia Commission of China，This new version of the Pharmacopoeia is targeted at the total amount of varieties of the pharmacopoeia in my country、Elementary number of gates category，The new version of the Pharmacopoeia has further expanded the collection range，Basically formed Chinese medicinal materials、Traditional Chinese Medicine Drinking Film、Chinese Medicine、Chemicals、Medicinal Accessories、Biological products and other categories of categories are complete drug standard system。It is worth mentioning that it is，The content of the new version of the Pharmacopoeia has been adjusted: First, the newly promulgated national drug catalog is basically covered by the newly promulgated and implemented.。
The new version of Pharmacopoeia specially focuses on absorbing stake online sports bettingstake online sports bettingadvanced testing technologies and analysis methods at home and abroad，Put the ion chromatography、MRI and other new methods in drug quality analysis as a legal method for drug quality control，Receive into the attached record，This has become consistent with the international advanced level。The preparation and implementation of the new version of Pharmacopoeia，It also pays special attention to the standard systemic improvement problem，Not only does the loaded variety increased by more than 40%，and the original standard of 70%improves or improves，This means that the requirements for the quality control of listed drugs are becoming stricter and stricter。
Wu Yan, deputy director of the State Food and Drug Administration (SFDA), put forward specific requirements for implementing the 2010 version of "Chinese Pharmacopoeia": First, the promotion and training of the new version of the pharmacopoeia。It is understood，Current，The National Pharmacopoeia Commission and the Training Center of the State Food and Drug Administration have jointly held a 19 -phase Pharmacopoeia training course，Completed nearly 10,000 people training。
Second, it is necessary to strengthen the supervision and inspection of the implementation of the new version of the pharmacopoeia。Scientific Research Unit、Drug production and operation enterprises must fully understand the update and change of the new version of the pharmacopoeia，Actively organize and carry out equipment transformation and technology innovation，Make sure to develop、Production of qualified products that meet the new version of Pharmacopoeia; drug supervision departments at all levels must handle the administrative license matters proposed by the enterprise in accordance with the requirements of the new version of the pharmacopoeia，Increase the supervision and inspection of the execution of the new version of the pharmacopoeia; the health administrative departments at all levels must mobilize the majority of medical institutions，Determine the requirements of using the new version of Pharmacopoeia to collect medicines，Standardize the clinical application of drugs。
Third, continue to promote the continuous development of national drug standards。According to Wu Yan,，To further improve national drug standards，Promote better and faster development of the pharmaceutical industry，SFDA has put the preparation of the 2015 version of the Pharmacopoeia on the working day。
"Luofu Mountain" test
Since the state proposed the "Pharmaceutical Standard stake betting appMy stake betting appAction" plan in 2006，Related product standards involved in the compilation of the content of the new version of the pharmacopoeia，It is the specific content obtained by the participation of several domestic pharmaceutical companies，The National Pharmacopoeia Council writes the new version of the Pharmacopoeia based on these data and content directly from pharmaceutical companies。
Encouragement of active participation of these companies，At the implementation of the meeting on September 15，The National Pharmacopoeia Commission also commended 5 pharmaceutical companies participating in standard research and formulation in China。
"Study on the quality standards of anti -inflammatory biliary tablets with Luofu Yam, Guangdong，It can be seen。"At this meeting，A person in charge of the National Pharmacopoeia Commission said。It is reported，Guangdong Luofushan National Medicine Co., Ltd., due to its contribution and innovation of new standards and innovations in the new pharmacopoeia standards, became one of the 5 companies commended。
It is understood，A total of 11 contents of the new quality standards of anti -inflammatory bile tablets in the new version of Pharmacopoeia，Including regulating the method of system，Add film clothing tablets; delete chemical reactions for identifying items，Added a thin layer chromatography with strong dedicated properties、Immerse outlet inspection、Measurement of the content of wearing lotus dectide and dehydration and dehydrated lotion。Among them, the key one "wearing lotus dect ester content"，It has nearly 5 times higher than the original standard (the original standard contains 1mg，blockbuster 3mg; new standard is 5mg and 10mg)，so as to make the product quality and efficacy more guaranteed。
Deputy Secretary -General of the National Pharmacy Commission Zhou Focheng believes，Anti -inflammatory and bile tablets are the simpler varieties in the current existing Chinese medicine preparations，But the time that it enhances the standards in an all -round way、Energy and financial resources is still large。So，Other more complicated Chinese medicine compound preparations should be improved，Time spent、energy and financial resources will be greater。
"The state encourages enterprises to actively raise standards，It mainly includes three major aspects: First, we can issue proofs to the enterprise，Explain which company is the participation of this standard，Enterprises can display it in various fields，For example, the stake sports betting appstake online sports bettingapplication for scientific research projects、Special pricing of drugs。Second, all the varieties that have been used to the Pharmacopoeia，We will write it when we make a clinical drug instructions，Clinical medication is a doctor's case book，This is the free publicity for the enterprise。Three is after we compiled the medicine，Free publicity to foreign countries。In addition, in the selection of basic drug directory in the future、Selection of medical insurance directory，We will all call the country to select in the pharmacopoeia。This is the benefit of entering the new version of Pharmacopoeia。”
From the perspective of Xie Zhijie, director of the Guangdong Provincial Drug Inspection Institute，The active improvement standard of Luofu Mountain Chinese Medicine "knows very well、The investment is in place、improvement very well "，This will inevitably inject new core competitiveness into the development of the enterprise。
Industry reshuffle acceleration is inevitable
From the beginning of the formulation of the new version of the Pharmacopoeia，Almost all people in the industry said，"The new version of the pharmacopoeia greatly improves the quality of the pharmaceutical quality，On the one hand, it improved the core competitiveness of the development of pharmaceutical companies，At the same time, it will inevitably lead to a reshuffle of the domestic pharmaceutical industry，The market status of the superior enterprise will also be even more prominent。”
From January to June 2010, the pharmaceutical manufacturing industry still maintains a high growth rate，January-June Cumulative total output value of 547.628 billion yuan，increased by 25.99%year -on -year;，Made in Chinese patent medicine、Biological and biochemical drugs have a faster growth rate。
While growing at high speed，The pharmaceutical industry will face a big shuffle。According to industry insiders，2010 version of the Pharmacopoeia standard，It will cause some standards that do not meet the standard of enterprise products。Changes in the product structure，Change of corporate status。The implementation of the new version of the "Specification of Drug Operation Quality Management" (GSP)，It is bound to cause some certified companies to stop production and close the rectification。Accelerate the merger combination of the enterprise。In addition，The introduction of the "Twelfth Five -Year Plan" plan for the medical circulation industry，It may also cause integrated pharmaceutical business。
The person in charge of the National Pharmacy stake sports betting appstake online sports bettingCommission said，The introduction of the new standard of Pharmacopoeia，is the high standard of ensuring domestic drugs in the system，Guide enterprises to produce high -quality varieties，Guide grassroots use high -quality domestic drugs，Institution to ensure the revitalization of Chinese medicine。
This person in charge pointed out at the same time，There are many problems in the use and bidding of basic medication and bidding，There are many problems if there is no bidding for the bottom of the bid。One aspect，Make a number of manufacturers co -produced by the original price of low price，Bad in a cost bid in malignant bids，Drug prices deviate from its own value in the bid，As a result, the company only reduces production requirements，To ensure the market; on the other hand，Foreign -funded enterprises、Social venture and separate pricing varieties often win at high prices。"Drug varieties are reshuffled in the use of medical institutions: Popular drugs gradually disappear，A large use of imported drugs in medical institutions、Pharmaceuticals and high -priced medicines in bidding。”
