The logic behind the new drug registration method: can the drug agent undertake the sales target?
Last Update: 2020-06-19
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< br / >< br / > < br / > < br / > < br / / > in fact, the "strictest" administrative measures for the registration and filing of medical representatives (Trial) (Draft for comments) was issued on December 22, 2017, and the new administrative measures for the registration and filing of medical representatives (trial) has been issued for more than two years since the last consultationIn the past two years, the situation of pharmaceutical industry has changed: < br / > < br / > < br / > < br / / > the pharmaceutical management department has reformed from CFDA to nmpaThe separate management of food and < br / > medicine < br / > not only highlights the importance of the state to the medical equipment, but also reflects the deepening of "release management service" and enables professional people to do professional things< br / > < br / > < br / > < br / > at the same time, < br / > at the same time, < br / > pharmaceutical < br / > in the aspect of < br / > pharmaceutical < br / >, various policies such as generic drug consistency evaluation, volume purchase (expanding varieties, expanding cities, expanding batches, expanding dosage forms (injections), and expanding fields (devices)) are also in full swing< br / > < br / > < br / > < br / >In the frequently exposed cases of drug purchase and sale corruption, the state has repeatedly ordered and repeatedly applied, but in essence it is difficult to correct the industry's "potential rules"9 ministries and 10 ministries and commissions have repeatedly issued documents to strictly check the financial situation of pharmaceutical enterprises, such as false and false reports of drug purchase and sale, false and increased "three virtual" invoices< br / > < br / > < br / > < br / / > in terms of medical insurance, the National Medical Insurance Bureau was established in 2018After the "three powers centralization", the "soul bargaining" and other measures have boundless powerThe DRG trial of medical insurance payment is a busy transformation of hospital pharmaceutical enterprises< br / > < br / >< br / > < br / >It is particularly necessary to point out that in the very important field of medicine, medical representatives are often the representatives of "derogatory words" for many historical reasons, and even form the so-called "medical representative problem"Therefore, how to define the professional identity and behavior of medical representatives has become an important issue of government and societyIt is imperative to reform the industry standard of medical representative management, and the management method of medical representative is coming outIt is believed that in the near future, the method will be implemented rapidly< br / > < br / >? < br / > < br / >Through comparison, it is found that there are some differences between the management methods of registration and filing of medical representatives in 2017 and 2020< br / > < br / >In 2017, the general office of the State Food and Drug Administration and the general office of the state health and Family Planning Commission jointly issued the document, while in 2020, the issuing unit is the National Drug Administration (nmpa)< br / > < br / >In 2017, it is called the "administrative measures for the registration and filing of medical representatives", and by 2020, it will become the administrative measures for the registration and filing of medical representativesThe change from "registration and filing" to "Filing" is only two words short, but it can still send some signals that the overall attitude is more relaxed than beforeThis point will be described in detail later< br / > < br / >There are 20 articles and 3029 words in 2017 edition; there are 18 articles and 2203 words in 2020 edition, with more than 800 words missing as a wholeWhat does this mean? The reason behind this is that the national level is more recognized for the profession of pharmaceutical representativesIf the measures of two years ago were strictly implemented, there would be no pharmaceutical representatives in the industry, and pharmaceutical enterprises would not be able to carry out the marketing of innovative products, which is obviously inconsistent with the concept of a strong pharmaceutical country and a strong R & D and innovation country advocated by the state< br / > < br / >Besides, there are more than 8 million college graduates this yearTherefore, compared with 2017, the 2020 version obviously relaxed many requirements, of course, the core is still the same< br / > < br / >? < br / > < br / > < br / > < br / / > in the second article of the method, the expression of "total imported drugs < br / > agent < br / > agent can be responsible for the record management of the registration of pharmaceutical representatives on behalf of the holders of overseas drug marketing license" is missing in the 2020 version, and the expression of "pharmaceutical salesperson does not belong to the pharmaceutical representative and is not included in the management of this method" is also missing We see that the same record of pharmaceutical representatives refers to the holders of drug marketing licenses, which is unchanged The new method that the general agent of imported drugs can act as an agent for the holders of overseas drug listing licenses to be responsible for the registration and filing management of drug representatives is removed < br / > < br / > < br / > < br / > But for CSO agencies that act as agents for overseas drugs, the actual standard may be stricter Because the state only recognizes the holders of the drug listing license, which is a constant theme The follow-up accountability companies are not in China, and in fact, there is no way to pursue accountability < br / > < br / > Can CSO companies of our domestic pharmaceutical companies do the filing of pharmaceutical representatives? It can be judged by documents From the method, it can be seen that in the 2020 version of the draft for medical representatives to file for trial implementation, there are 11 references to authorization That is to say, when our drug marketing license holder authorizes to CSO, as long as CSO can reach a consensus with the drug marketing license holder, the drug marketing license holder can undertake, So the pharmaceutical representatives authorized to CSO, to achieve all behavior compliance, in theory, can, of course, this means that all responsibility risk compliance is in the drug listing license holders < br / > < br / >? A question mark is needed As everyone concerned knows, in May this year, nine ministries and commissions issued a severe crackdown on CSO's false invoice notice I believe that CSO will become more and more difficult It is reasonable for enterprises to build their own teams, but it does not mean that it will disappear < br / > < br / > < br / > < br / > the essence of medical representatives lies in the return of value < br / > < br / > < br / > < br / > from the perspective of practice content and qualification, we can see the third provision of 2017 version, which stipulates that medical representatives can communicate with medical personnel through the following forms, and also stipulate that before engaging in academic promotion and other activities, The application (or invitation for out of hospital activities) shall be submitted by the drug marketing license holder to the medical institution, and can only be carried out with the approval of the medical institution < br / > < br / > On the one hand, the 2020 edition recognizes the necessity for medical representatives to carry out academic activities There is no doubt that the government recognizes the academic value of medical representatives On the other hand, the 2017 version of the method changed the provision that medical representatives can communicate with medical personnel in the following forms into the provision that medical representatives in 2020 can carry out academic promotion and other activities in the following forms, from the prescribed main body to carry out academic activities Again, the government hopes to regulate the behavior of medical representatives and transfer academic value It also further proves that the government has relaxed the conditions to allow medical representatives to do academic promotion It shows that the real medical representatives are mainly academic, mainly technical, and assist the medical staff in rational drug use < br / > < br / >, The decision-making power of education, major and work experience of medical representatives shall be handed over to pharmaceutical enterprises This shows that in the future, as long as you have experienced pre job training and have registered for record, and your ability and post can match, in line with the relevant provisions of the industry, you can be engaged in medical representatives As for how to evaluate the ability and position, the decision-making power is still in the pharmaceutical enterprises, < br / > < br / > < br / > < br / / /, but it does not mean that the pharmaceutical representatives do not need to have the academic qualifications of these majors or have relaxed requirements for the majors they have learned? Maybe not yet It is clearly stated in the document that the requirements for education and work experience of medical representatives should be set According to the current industry situation, pharmaceutical companies will only be more and more strict in screening pharmaceutical representatives For those who are interested in entering the pharmaceutical industry, as long as the enterprise meets the requirements of education background, working experience and specialty of the enterprise and passes the pre job training, then the state agrees you to become a pharmaceutical representative At the same time, we find that the 2020 version of the method proposes that the holders of pharmaceutical marketing license can entrust social institutions to carry out training, And be responsible for the authenticity of training records In fact, the essence is to make it clear that medical representatives need to be more and more professional, and only after training can they take up their posts, which is a basic threshold < br / > < br / > Through this provision, we can easily find that the demand for medical representatives in the future will actually be higher and higher, because the policy forces pharmaceutical companies to select high-quality medical practitioners, and we also predict that the number of medical representatives will not expand as savagely as before, because the industry is highly intensive, and our employees will only be more and more demanding, according to the 120 million population of you in Japan, Only 50000-60000 medical representatives can be calculated At present, we are conservative between 2-3 million How many medical representatives do 1.4 billion need? < br / > < br / > The 2020 version highlights the primary position and the first record holder of the drug listing license The first person responsible for the record of all the drug representatives is the drug listing license holder At the same time, it increases the certificate of the authenticity of the record information of the drug listing license holder, which is equivalent to a commitment made by the drug listing license holder on the platform According to the 2020 version of the measures, there is a clear Commission Department for the filing of pharmaceutical representatives, and the State Drug Administration entrusts the China Pharmaceutical Association to build and maintain it In the future, the release, documents, regulations and publicity of all recorded information will be issued through the China Pharmaceutical Association
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