Drug administration law 2019 in the eyes of pharmaceutical makers

Recently, with the approval of the new revised Drug Administration Law in 2019, major news media have entered the atmosphere of discussion again! The newly revised Drug Administration Law not only summarizes the achievements of drug industry reform in the past few years, but also constantly makes specific adjustments to adapt to China's current national conditions For example, it gives a further clear explanation for the most common concerns of the people, such as "definition of fake drugs", "drug shortage", "high drug price", "four strictest" So, how do pharmaceutical industry practitioners view the new revised Drug Administration Law 2019? What's closer to us? Please look at my heart 1 No mention of "GMP / GSP" Certification & remember "4 strictest"! The newly revised Drug Administration Law clearly points out that it will take "four strictest" as the core: namely "the strictest standard", "the strictest supervision", "the strictest punishment", "the strictest accountability"; at the same time, it does not mention "GMP / GSP" certification There is no mention of certification and explicit cancellation, which is a different concept, and further details are needed In fact, no matter how to implement, the adjustment of this aspect is inevitable, which is the trend of the industry development to a certain stage! But don't think this is the end of the final exam, on the contrary, it will be the beginning of the test at any time, and will be more strict and more serious! Flight inspection is bound to become a routine, punishment is bound to be more severe! Therefore, for the pharmaceutical industry, especially the GMP / GSP system, the overnight pit can not be left, and the standardization and authenticity must further increase the investment in management costs! (the picture comes from the official website of the drug administration) 2 "Definition of fake drugs" should be viewed objectively, and we should try not to step on it in minefields! The amendment clearly stipulates that fake drugs include "drugs with ingredients inconsistent with those specified in the national drug standards, drugs with non-conforming ingredients or drugs with other kinds of ingredients, deteriorated drugs, and drugs with indications or functions beyond the specified scope" It has to be said that the definition of fake drugs in the newly revised Drug Administration Law is more scientific and more in line with the objective state of drugs; but do not think that this is the rationalization of Lu Yong's purchase of Indian anti-cancer drugs in the movie I am not the God of drugs! At the same time, the amendment stipulates that "those who import a small amount of drugs that have been legally marketed abroad without approval may be given a mitigated punishment if the circumstances are relatively minor; those who do not cause personal injury or delay treatment may be exempted from punishment" Does that mean that I can buy a small amount of it on behalf of others? The author thinks that "drug purchasing on behalf of others" is a minefield with fluke psychology Don't step on it! In recent years, we are always surrounded by a wide range of smart shopping agents, drugs, food, cosmetics are even more severely affected! For the purchasing industry, the author has been very distrustful of it! First of all, there must be an output of benefits from purchasing on behalf of others Naturally, purchasing agents hope that the output of benefits tends to be more self oriented, and the reliability of the purchase funds is bound to be reduced! Furthermore, for drugs, who can guarantee that drugs from purchasing sources are legal? How to judge whether it is harmful to human body when purchasing drugs on behalf of others? How to determine whether the treatment is delayed? A lot of evidence is hard to collect, so the author thinks that the newly revised Drug Administration Law does not leave a gap for purchasing agents, but requires more strict behaviors! (the picture comes from the official website of Drug Administration) 3 We should pay attention to this channel when selling drugs online! Be careful when purchasing drugs on behalf of others! Pay attention to network sales! The amendment stipulates that: "the holders of drug listing licenses and drug distributors shall abide by the relevant provisions of this Law on drug distribution when selling drugs through the Internet Vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and other drugs under special state control shall not be sold on the Internet " The main battlefield of domestic drug sales is hospitals The purchase of drugs by hospitals has almost become the support point for the survival of many pharmaceutical enterprises! In fact, in recent years, online drug sales have become more and more popular, and many pharmaceutical enterprises have begun to enter this channel, trying to occupy the new commanding point of drug circulation in the future, especially those small and medium-sized enterprises with certain strength, for the new circulation channels in the future, they must be more sensitive and dare to try to innovate, otherwise the strength gradient has gradually become clear in China Under the environment of, it is difficult to fly over qualitatively Furthermore, there are still various restrictions on the current environmental network sales of drugs, and special drugs can not enter the channel, but it does not mean that this road will not be opened in the future Once the channel is mature, the pharmaceutical enterprises that have not been arranged in advance will be left a big step in the highly developed information today! Pharmaceutical companies are traditional industries, not fake! However, if we can't keep up with the pace of the times, it is a concrete manifestation of the lack of innovation consciousness! (source of information: the official website of the National People's Congress) 4 Review and approval & innovative drugs & children's medicine When it comes to innovation, the general provisions of the drug administration law clearly stipulate that the State encourages research and development of new drugs, and that children's medicine is the key direction to encourage innovation As a drug practitioner, a front-line personnel, the author is more concerned about how to carry out the work of industry personnel in the future? And to what kind of guidance as the right direction! To encourage innovation is the country's overall requirement for all walks of life in recent years! The innovation of the pharmaceutical industry mainly focuses on the development of new drugs In 2018, the number of innovative drugs increased by 75% compared with 2016 In 2018, a total of 48 new drugs were approved, including 18 new anti-cancer drugs, an increase of 157% compared with 2017 The author has made statistics on the application of new drugs in China before In 2018, the number of applications for new drugs in China was nearly 100, while in the first half of 2019, the number of applications was significantly higher than the same period in 2018, and the statistical number was the first application variety, and the supplementary application and other varieties were not included in the statistical scope It can be seen that the development of new drugs in China has been fully "popularized"! Behind the achievements of new drug development, it is absolutely inseparable from the overtime work of review and approval, and also inseparable from the scientific guidance of drug reviewers for the new drug application process More responsible review and approval make the new drug development process not only exciting in quantity, but also escort in quality! For children's drugs, the amendment emphasizes that "the state will take effective measures to encourage the development and innovation of children's drugs, support the development of new varieties, dosage forms and specifications of children's drugs that meet the physiological characteristics of children, and give priority to the review and approval of children's drugs" The state's encouragement and innovation of children's medicine has been mentioned more than once, and many development platforms for children's medicine have been set up, but until now, new varieties of children's medicine are still a big problem for children in China! The enthusiasm of drug R & D enterprises is not enough, children's drug R & D experience is not enough, clinical trials are difficult, and so on.. I believe that the development of children's drugs will still be difficult in the future, but with the popularization of science and the continuous improvement of people's knowledge level, the steady improvement of all aspects of children's drug development is an inevitable trend, but we should be patient about it (source of information: Official Website of the National People's Congress) 5 The author feels that the newly revised Drug Administration Law of 2019 is by no means thorough in one word and one comment While we understand it, we also need to see the effect of the specific implementation, which more reflects the development of China's drug industry! As practitioners in the pharmaceutical industry, we do not need to recite the drug administration law, but we need to understand that this learning process is very helpful for the construction of our pharmaceutical system! As the system continues to be built, you will find that the pharmaceutical industry is still very meaningful and interesting! Statement: this opinion only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.