2015 version of the Pharmacopoeia revision has gradually opened its standard will be in line with international standards
With the implementation of the 2010 version of the Pharmacopoeia, 2015 Pharmacopoeia revision has been gradually opened.
December 23, 2010, the establishment of the tenth Pharmacopoeia Commission and the 60th anniversary of the Chinese Pharmacopoeia held in Beijing, marking the 2015 version of "Chinese Pharmacopoeia" preparation work kicked off. The meeting stressed that the "load standards and the number of simultaneous increase," the goal will lead the industry to a higher level of quality.
With international standards
"2015 version of the general goal of the Pharmacopoeia in the species to achieve full coverage, in terms of quality to achieve an effective upgrade." National Pharmacopoeia Commission official responsible person said.
In the 60th anniversary of the Chinese Pharmacopoeia, Minister of Health Chen Zhu stressed that "we must accurately grasp the 2015 edition of" Chinese Pharmacopoeia "preparation requirements, closely around the 'scientific development' of the distinctive theme, and strive to achieve 'collection standard level and quantity synchronization Especially from the standard level, the "Chinese Pharmacopoeia" as the core of the national drug standard system to be more perfect and sound, the level of drug quality control to be substantially increased, more stringent; chemical and biological products standards To achieve the same goal with the international advanced level of development; Chinese medicine standards to me, leading the international development. From the quantitative point of view, the collection of species must fully cover the "national essential drugs directory" and "national basic medical insurance, work injury insurance and Maternity insurance drugs directory "to meet the people of the next period a period of growing health needs and drug safety needs.
On the standard level and international standards, there are relevant experts revealed that the 2015 version of the Pharmacopoeia is mainly reflected in the following aspects: a comprehensive tracking convergence - chemical drugs, biological products and international advanced level to achieve full integration; local lead development - Chinese medicine standards To achieve the goal of leading the international advanced level; international exchanges and cooperation - adhere to the standard, the standard, the succession of the strategy, the main chemical products, biological products, the main reference, The tracking type, participation type, create the type of the Trinity, separate and progress, comprehensive convergence, focusing on breakthrough ideas.
In addition, the pharmacopoeia load will be significantly increased, including: the national standard is divided into common standards (Chinese Pharmacopoeia and ministerial standards) and personality standards (registration standards), straighten out the relationship; unified the same species, the same dosage form , The same route of administration of the standard, to solve the standard deviation caused by the difference caused by the inequality of the problem.
Guangdong Provincial Institute of Drug Testing Xie Zhijie said, 2015 version of the Pharmacopoeia will be fully formed by the market-led, government guidance, business entities, policy support standards to form a new mechanism. This means that the government will change the situation in the past to arrange everything, focusing on "the development of rules, evaluation criteria, arbitration standards, supervision and implementation", while the main business status highlights, to achieve "by the spectator to the participants, from passive to active development "The conversion, must be" production marketing and technical research both "adjustment.
Attention to inheritance innovation
For the inheritance and innovation of the standard of Pharmacopoeia, Chen Zhu stressed that in particular, we should attach importance to inheriting the traditional culture of traditional Chinese medicine, consolidate and expand the important achievements made in the standardization of traditional Chinese medicine and realize the equal emphasis on modern medicine and traditional medicine. To strengthen the independent intellectual property rights of drug standards research, to encourage independent innovation, promote the rapid transformation of pharmaceutical innovation into productive forces. To actively protect the medicinal resources, promote the sustainable development of the cause of medicine. In addition, in the preparation also in accordance with the initiative to promote simple and practical ideas, to encourage the use of fast check equipment and means to enhance the practicality of the drug standards and operability.
"The goal of a Chinese medicine standard is to lead the development direction and level of international traditional medicine and natural medicine standards, and to strengthen safety and quality controllability," he said at the same time. First, the relevant groundbreaking work, including standardized safety research, mechanism (modification, efficiency, attenuation), harmful residue limits, methods, etc .; the second is to improve the quality standards of Pieces, Including the increase of suitable area zoning and harvesting period, the exclusive activity of multi-component comprehensive determination method (a multi-evaluation, a test multiple, fingerprint, DNA molecular identification and bar code, bio-determination), attention to sustainable development of resources and green science Development, development of Pieces control extract, etc .; Third, the development of the national standard Pieces of Chinese medicine, and pharmacopoeia standard supporting the use of the same directory, the former focus on the standard, which focuses on the specification of the process.
In addition, the importance of national medicine has become one of the highlights of the 2015 version of the Pharmacopoeia. January 22 to 24, 2011, the State Pharmacopoeia Commission held in Guangzhou, the tenth session of the Codex Committee of National Medicine Professional Committee of the first meeting, highlighting its importance. In addition, the 1950 version of the Pharmacopoeia preparation outline of the standardization of national medicine work has been put forward a clear task and objectives, that is, "focus on the study of drug quality to solve the weak links and weak varieties", clearly focus on the collection of commonly used, Mongolian, Selection principle.
December 23, 2010, the establishment of the tenth Pharmacopoeia Commission and the 60th anniversary of the Chinese Pharmacopoeia held in Beijing, marking the 2015 version of "Chinese Pharmacopoeia" preparation work kicked off. The meeting stressed that the "load standards and the number of simultaneous increase," the goal will lead the industry to a higher level of quality.
With international standards
"2015 version of the general goal of the Pharmacopoeia in the species to achieve full coverage, in terms of quality to achieve an effective upgrade." National Pharmacopoeia Commission official responsible person said.
In the 60th anniversary of the Chinese Pharmacopoeia, Minister of Health Chen Zhu stressed that "we must accurately grasp the 2015 edition of" Chinese Pharmacopoeia "preparation requirements, closely around the 'scientific development' of the distinctive theme, and strive to achieve 'collection standard level and quantity synchronization Especially from the standard level, the "Chinese Pharmacopoeia" as the core of the national drug standard system to be more perfect and sound, the level of drug quality control to be substantially increased, more stringent; chemical and biological products standards To achieve the same goal with the international advanced level of development; Chinese medicine standards to me, leading the international development. From the quantitative point of view, the collection of species must fully cover the "national essential drugs directory" and "national basic medical insurance, work injury insurance and Maternity insurance drugs directory "to meet the people of the next period a period of growing health needs and drug safety needs.
On the standard level and international standards, there are relevant experts revealed that the 2015 version of the Pharmacopoeia is mainly reflected in the following aspects: a comprehensive tracking convergence - chemical drugs, biological products and international advanced level to achieve full integration; local lead development - Chinese medicine standards To achieve the goal of leading the international advanced level; international exchanges and cooperation - adhere to the standard, the standard, the succession of the strategy, the main chemical products, biological products, the main reference, The tracking type, participation type, create the type of the Trinity, separate and progress, comprehensive convergence, focusing on breakthrough ideas.
In addition, the pharmacopoeia load will be significantly increased, including: the national standard is divided into common standards (Chinese Pharmacopoeia and ministerial standards) and personality standards (registration standards), straighten out the relationship; unified the same species, the same dosage form , The same route of administration of the standard, to solve the standard deviation caused by the difference caused by the inequality of the problem.
Guangdong Provincial Institute of Drug Testing Xie Zhijie said, 2015 version of the Pharmacopoeia will be fully formed by the market-led, government guidance, business entities, policy support standards to form a new mechanism. This means that the government will change the situation in the past to arrange everything, focusing on "the development of rules, evaluation criteria, arbitration standards, supervision and implementation", while the main business status highlights, to achieve "by the spectator to the participants, from passive to active development "The conversion, must be" production marketing and technical research both "adjustment.
Attention to inheritance innovation
For the inheritance and innovation of the standard of Pharmacopoeia, Chen Zhu stressed that in particular, we should attach importance to inheriting the traditional culture of traditional Chinese medicine, consolidate and expand the important achievements made in the standardization of traditional Chinese medicine and realize the equal emphasis on modern medicine and traditional medicine. To strengthen the independent intellectual property rights of drug standards research, to encourage independent innovation, promote the rapid transformation of pharmaceutical innovation into productive forces. To actively protect the medicinal resources, promote the sustainable development of the cause of medicine. In addition, in the preparation also in accordance with the initiative to promote simple and practical ideas, to encourage the use of fast check equipment and means to enhance the practicality of the drug standards and operability.
"The goal of a Chinese medicine standard is to lead the development direction and level of international traditional medicine and natural medicine standards, and to strengthen safety and quality controllability," he said at the same time. First, the relevant groundbreaking work, including standardized safety research, mechanism (modification, efficiency, attenuation), harmful residue limits, methods, etc .; the second is to improve the quality standards of Pieces, Including the increase of suitable area zoning and harvesting period, the exclusive activity of multi-component comprehensive determination method (a multi-evaluation, a test multiple, fingerprint, DNA molecular identification and bar code, bio-determination), attention to sustainable development of resources and green science Development, development of Pieces control extract, etc .; Third, the development of the national standard Pieces of Chinese medicine, and pharmacopoeia standard supporting the use of the same directory, the former focus on the standard, which focuses on the specification of the process.
In addition, the importance of national medicine has become one of the highlights of the 2015 version of the Pharmacopoeia. January 22 to 24, 2011, the State Pharmacopoeia Commission held in Guangzhou, the tenth session of the Codex Committee of National Medicine Professional Committee of the first meeting, highlighting its importance. In addition, the 1950 version of the Pharmacopoeia preparation outline of the standardization of national medicine work has been put forward a clear task and objectives, that is, "focus on the study of drug quality to solve the weak links and weak varieties", clearly focus on the collection of commonly used, Mongolian, Selection principle.
