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| CSO liberation, completely affect all the pharmaceutical companies! |
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| Author：中国铭铉 企划部 Release Time：2017-9-22 10:05:41 Number Browse：1481 |
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The medical network September 22 general administration of inquiry: the national drug generation record, must bind the production enterprise! But left the way for CSO!
On September 15, the second session of the Chinese drug regulatory science conference held in Beijing, was invited to attend the blue parker in the know on BBS "drugs circulation supervision system reform" : version of the medicine generation of records and record the main body is drug firms, but may authorize a third party as a medicine generation of the company.
The plan will be completed by the end of December, according to the deployment of the previous "2017 health care mission".
▍ national medicine generation for the record, and will be "binding" drug firms
At the meeting, the head of the pharmaceutical supervision division of the state administration of food and drug administration said that the main body registered for the registration of medical representatives was the pharmaceutical production enterprise.
The person in charge is clear: the pharmaceutical enterprise needs to sign labor contract or authorization letter with the drug agent, be responsible for the true accuracy of the information of the drug generation record; It is necessary to carry out necessary training for drug generation, including laws and regulations, professional ethics, professional knowledge of medicine and pharmacy, product related knowledge, etc.
Pharmaceutical enterprises shall not assign drug sales tasks to the drug generation, and shall not fabricate the training situation or intentionally provide other false information in the registration and filing. At the same time, drug generation is not allowed to contact medical personnel in private, not to participate in the unification and so on.
Thus, as the subject of the record, the drug companies have more responsibilities.
▍ drug firms may authorize a third party, as a representative of the medicine
On August 25th, after the Shanghai food and drug administration issued a trial scheme for the registration of medical representatives in Shanghai, the industry was horrified. Because the documents in Shanghai are clear about the drug delivery of drug companies, the company has not said anything about the business enterprise and the professional promotion company (CSO).
But a forthcoming version of the administration is likely to give the CSO a chance to live.
After finished the record Chinese medicine enterprise need to assume responsibility, drug administration and supervision of director added "drug production enterprises authorized other personnel as a representative of the pharmaceutical, medical representatives of labor relations, should comply with the requirements of the enterprise."
▍ CSO relieved, great liberation
To this, the executive vice President of the China pharmaceutical enterprise management association said that "there is a sentence that CSO is relieved!"
Niu zhenggan believes that pharmaceutical manufacturers and pharmaceutical representatives sign labor contracts or authorization books in the practice of the pharmaceutical representatives introduced by the relevant responsible officials of the state administration of drug administration.
In this way, the pharmaceutical producing enterprises can be entirely by their employees as a representative of the pharmaceutical products of the enterprise legal compliance, can also authorize a third party, implement marketing outsourcing (CSO mode), so as to better integrate social resources configuration, improve efficiency and save cost.
With the development of the society progress, industry division of labor is more and more refinement is inevitable, division of professional people do professional thing, thereby improving the efficiency of the society as a whole, including a medical representative of the pharmaceutical industry as a whole should be the same.
In the future, the real CSO (outsourcing of professional marketing) will be developed in the same way that the outsourcing of CRO (r&d outsourcing), CMO (outsourcing) and other fields of expertise will be developed.
At the same time, cyberan notes that the administration of the drug generation overlaps with the right of ownership, and in fact binds the pharmaceutical companies, drug generation and CSO closely together. Even if authorized, but as the subject of the record, pharmaceutical companies must participate in the management of compliance, otherwise, it will be jointly and severally liable if an accident happens.
I believe that there will be a requirement in the administration's plan.
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