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    Home > Medical News > Medical World News > Wave Eye Detective 2020 Sip will be the former Secretary-General of the National Pharmacopeia Commission Zhang Wei: the new version of the Pharmacopeia on drugs.

    Wave Eye Detective 2020 Sip will be the former Secretary-General of the National Pharmacopeia Commission Zhang Wei: the new version of the Pharmacopeia on drugs.

    • Last Update: 2020-09-10
    • Source: Internet
    • Author: User
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    On August 12, the Health Industry Capital Summit kicked off at the Boao Forum for Asia Hotel in Hainan, with the opening of the 2020 China Health Industry Ecological Conference.
    the summit was organized by Zhongkang Information, CITIC Securities and Guosheng Securities.
    held a six-day conference on the theme of "Day by Day - A New Era of Health Management for the Full Life Cycle".
    As the conference's in-depth cooperative media, Sina Pharmaceuticals (micro-signal: sinayiyao) full special report, special topics, micro-blogs, WeChat synchronous pictures, for the attention of the guests of this industry event to bring a visual feast in person, we will be the first time to package the conference dry goods hard goods presented to the audience.
    China Pharmacopeia is the basic legal basis to be followed in the supervision of drug research and production, focusing on solving outstanding problems of drug quality and safety, is an important part of the national drug standards, at this opening meeting, zhang Wei, former Secretary-General of the National Pharmacopeia Commission, introduced the impact of 2020 Chinese Pharmacopoeia on the pharmaceutical and health industry.
    , the following is the former Secretary-General of the National Pharmacopeia Commission Zhang Wei's speech: When it comes to pharmacopeia has to talk about drug standards, the standard is technical provisions.
    drug standards are developed from the drug's own research and development, biological nature, including the source process, etc. , used to test the quality of the drug and determine whether the quality requirements are met.
    Pharmacopeia is an official collection of these provisions, the general pharmacopeia are developed by the national drug regulatory authorities, as well as regional pharmacopeia, as well as the national pharmacopeia, as well as the World Health Organization Pharmacopeia, which is the participation of all countries in the development of a pharmacopeia standard collection.
    pharmacopeia has a history of thousands of years in China, when it was herbology.
    Pharmacopeia is a herbal, pharmacological evolution, pharmacopeia's biggest characteristics, in the past is the traditional folk medical classics, its characteristics are normative, relationship issues may be the law.
    in the Qin Dynasty, the development of Chinese medicine is very good, there have been a lot of drug books are mainly folk, these to be famous is the East Han herb, when received more than 300 kinds of medicine.
    At that time, it was believed that the initial local scale of the herb of the god farmers, to the North and South Dynasties when the pharmacologists in the herb of the god farmers made a herb economic book, this includes more than 700 kinds of drugs, including the medicinal nature of the drug have, is quite standardized, with the prototype of the pharmacopeia.
    During the Tang Dynasty, China's social strength was strong, the overall development of medicine, a Su Jing people on the book court led more than 20 people to compile the God's agricultural herbs, spent three years, collected more than 800 kinds of medicine, now the pharmaceutical historians think that the first step in China's history by the government to compile and promulgate the drug books.
    We see different historical dynasties, and finally Li Zhizhen is a medical work of medical doctors, this is also the collection of books from previous generations, this is actually compared with quality control, identification and measurement and usage usage.
    And then look at the development of modern pharmacopeia in the West, and in the 15th century, with the capture of printing, a European pharmacopoeia, and then there were cities where we saw that we were eight hundred years earlier than these pharmacopeias.
    Modern pharmacopeia was the first modern pharmacopeia in the United States in the 19th century, in 1820, and then Japan, now about 40 countries around the world have their own national pharmacopeia, there are many countries do not have their own pharmacopeia, there are some international pharmacopeia, international pharmacopeia more guidance to the world including developing countries.
    as a whole, the national standards a total of nearly 18,000 standards, this is the drug standard system, of course, Chinese medicine harvest more than 20205,000 kinds, basically covering about 80% of the national health insurance directory.
    national standard system includes national standards, regional standards and social standards, enterprise standards four.
    Due to historical reasons, the current also retained the local pharmaceutical standards of Chinese medicine tablets, and now many pharmaceutical industry societies have set up a social group standards advisory committee or professional committee, committed to the introduction of some social standards, this is also a very active point, in fact, a supplement to the national drug standards, and even many standards are forward-looking.
    enterprise standards, this time the law also mentions that many categories of enterprises have internal standards or factory standards, enterprise standards should be more stringent than national standards, so as to ensure that products meet the requirements of national standards, these standards are interdependent relationship.
    Speaking of the value of the pharmacopeia role, some people think it is the ceiling, some people think it is the floor, debate all kinds of rhetoric, I think it is very simple to see where to stand, for China, our standard role is mainly more of a guiding role, because we all know that our country a lot of standards, and our past medical development basic research is relatively weak, good and bad, not only standards are not the same, there is a problem of standard implementation.
    Our more standards are two roles, a guard against the security bottom line, at least a threshold, this threshold has a guiding role, in fact, is the leading role, just said the community standards also played a leading role.
    We officially have to have some role, one is some standard technical provisions, in accordance with these technical provisions, of course, the standard has some extension, that is, to the source of production, raw materials supplies and even the control of the entire production process, these have a certain concept, and later, is the use of the process after the market in the use of quality factors, to establish some standards, forming a standard management system, including production online testing.
    is the leading role, our country now a lot of industries are also how small scattered situation.
    , products to go out to sea to the world standard first, the core enterprise is a killer, the previous period we fight price, now spell quality and performance.
    Again, it should be a bridge to the international community, because the industry said that the standards of the world or super-class enterprises, in addition, every year held a conference, which introduced a white paper, specifically for value, the purpose of this white paper is to promote the importance of appeal to all sectors of society, including the Government.
    Mainly includes a pharmacy to develop open and transparent procedures, all pharmacy standards are based on scientific relying on data, big data analysis information, we pharmacies need the accumulation of basic data in these industries, there is a response to public health needs, after this outbreak, the pharmacopeia in various countries are hot discussion, the market drug standards are perfect, how to connect with these products.
    This central standard management issues, continuous evaluation and improvement to form a new standard, and then drive the extension of standards, there is an emphasis on global cooperation, pharmaceutical production and sales globalization, a while ago we also said that the drug research and development perspective synchronously listed, so the drug regulatory requirements and drug standards must also be coordinated must correspond, because Exporters in particular want to use one, one is to ensure the availability of drugs, we think this standard no one production is also a problem, and another is for the user's education, our standard is a double-edged sword, can play a catalyst for trade exchanges, but also may be some enterprises as a monopoly tool, to do a good job of this balance.
    is the drug standard rod what use, said to go or evaluation of the quality of a tool.
    We are different research methods, the industry often do this, speech such a few are standard methods, we should look at the quality in addition to standards in addition to more attention to quality issues, quality of the implementation of standards, some strict loose wide, the other is accuracy, accuracy trend analysis, we are now concerned about in addition to the original research, the future is more challenging time, the quality of production to maintain.
    In fact, now a lot of quality through testing out, now further enterprises how to do, now quality management, from clinical efficacy CMC to GMM, one is gradually deepening, one is gradually the front end to develop.
    affect the quality of many links, research and development, production, flow will have an impact.
    the biggest change in the drug management law independent listing licensing system, there are many standards before the market, GMP, GCP and so on.
    this concern is safe and effective, quality control, especially generic drugs, after the market there are many standards, GMP, GOP.
    after the listing of the evaluation of the main focus on such points, mainly the quality of effective research.
    our standards are established around the entire life cycle of a period of research and development, growth, maturity, decline.
    the relationship between standards and innovation is contradictory, the coordination of standards should be personalized, the two should cooperate with each other to promote each other, after all, standards are innovative mechanisms, but also to improve the effectiveness of the mechanism.
    the new version of the Chinese Pharmacopoeia, the real implementation of December 30 this year, there are several months of transition period, the main varieties included, there are some new testing methods, in addition, around the safety of the effectiveness of the requirements to improve, there is coordination of international standards.
    the construction of this standard system of architectural management style varieties of these have been a comprehensive review and revision, in addition to the concept throughout the life cycle, as well as pay attention to the production process and source control, the whole process of standard system construction.
    For the construction of the standard system is very important, advanced technology safety standards the biggest change is that the Chinese medicine industry has some reactions, think that improved, in fact, this accumulation of a lot of data, this time or carefully put in the guiding principles of everyone reference implementation, this actually guide the industry we should all participate in the accumulation of data, of course, we are still in accordance with the international unified requirements, formula conversion and risk assessment, on this industry there are some doubts, I want to adhere to because after all is the bottom line of security.
    One is a new admissibility, this quality emphasizes why the new evaluation to do so, mainly safety standards, one is its functional standards, effectiveness said, this is a long term, the current indicators more also have a close relationship of efficacy, chemical concern, this is international standard coordination, we have done a lot of work on drug standards coordination.
    Syn up, from a standard system to establish the concept of building, we strengthen the whole cycle and pay attention to the whole process, and then a solid foundation for Chinese medicine, including scientific formulation, in fact, this is a standardized cultivation, the source of governance has a very important lead.
    note: There are deletions in the original text.
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