Why did the second edition of the "Pharmaceutical Representative Filing Measures" not involve the Health and Care Commission?

Guide: Why did the issuing unit not have the National Health and Care Commission?The new version of the filing management measures issued by the State Drug Administration, which relates to the issue of MAH's registration and filing of medical representatives, and does not involve the contents of how medical institutions regulate and manage the conduct of medical representativesThe core of the new management method ofis MAH, which is essentially the responsibility of MAH for the full life cycle of drugs in the new Drug Administration Lawalthough the medical representative's academic qualifications, professional and work experience requirements have been eliminated, the requirements for medical representatives will be higher and more comprehensive in the context of market competitionthe medical representative is engaged in academic promotion of personnel, pharmaceutical sales staff do not belong to the pharmaceutical representative-sentence incidentJune 5, 2020, the Comprehensive Division of the State Drug Administration issued the Measures for the Administration of the Record of Pharmaceutical Representatives (Trial) (draft for comments) to solicit opinions from the communityThe request period is until 19 June 2020this is the second time in two and a half years since the former State Administration of Food and Drug Administration and the State Health and Care Commission issued the Measures for the Administration of the Record of Pharmaceutical Representatives (Trial) (Draft for Comments) in December 2017What's the difference betweenthe new management approach?compared with the previous edition, the second version of the management method has made a lot of major changesinformation, table finishing, Yin DaniWhy did the messaging unit not have the National Health and Care Commission?first, we note that the only agency issuing the document is one agency of the State Drug Administrationpharmaceutical representative is engaged in the academic promotion of medicine, the hospital is one of its main activities In recent years, the medical representatives "full hospital fly" often and the field of pharmaceutical purchase and sale and medical services in a variety of improper wind, the national and local health committee has repeatedly issued documents to regulate the activities of medical representatives in hospitals So why is there no participation of the National Health and Care Commission in the issuing unit? After reading through the management measures, it can be found that the content of the document is how the drug market license holder (MAH) to carry out the registration of pharmaceutical representatives For medical institutions, only mention the need to check the corresponding information on the filing platform, not to allow the non-recorded personnel to enter, and does not involve how medical institutions to regulate and manage the behavior of medical representatives, so the distribution unit did not have the health care committee involved in the rational What is at the heart of the Second Edition Management Approach? at the heart of this edition of the Measures for the Filing of Pharmaceutical Representatives mah Article 2 of the Management Measures clearly states: "Pharmaceutical representatives refer to professionals who represent the holders of drug marketing licenses (enterprises holding drug approval numbers, the same as below) who are engaged in the transmission, communication and feedback of pharmaceutical information within the territory of the People's Republic of China." Article 4 requires MAH "to sign a labor contract or power of attorney with a pharmaceutical representative" In other words, MAH is the employer or authorized party of the pharmaceutical representative, for which the medical representative works The follow-up provisions further state that the record management of medical representatives is completed by MAH August 26, 2019, the 12th session of the Standing Committee of the 13th National People's Congress voted to adopt the amendment to the Drug Administration Law of the People's Republic of China, which came into effect on December 1, 2019 A major fundamental reform measure in the newly revised Drug Administration Act is the full implementation of the drug market licensing system Under the new Drug Administration Law, drug registration applicants become MAH when they obtain a drug registration certificate and are responsible for the safety, effectiveness and quality control of drugs during the life cycle of drug development, production, operation and use This also includes, of course, academic promotion activities carried out by medical representatives Therefore, the essence of the new edition of the Measures for the Record Management of Pharmaceutical Representatives is to implement the part related to the promotion of drugs in the new Drug Administration Law, which is related to MAH's responsibility for the full life cycle of drugs Is the threshold for medical representatives low? many people have noted that the management approach to eliminate the previous medical representatives of the academic qualifications, professional and work experience requirements, changed to MAH "should be the medical representative set academic qualifications and work experience requirements, and pre-job training." Does this mean that the threshold for medical representation is low? not As mentioned earlier, the core of this version of the management approach is the implementation of MAH's responsibility, so the choice of talent to serve as a medical representative in this position, how to carry out training, so that they can be competent for this job, MAH as the responsible person need to consider the content, without the need for the national level to make hard and fast provisions medical representatives engaged in a very strong professional academic promotion work, need to communicate with medical personnel, hold academic conferences, lectures, provide academic materials, etc , it is difficult to imagine that a non-medical related background of the big layman can do a good job Mah for their own interests, will inevitably choose better talent Therefore, although the provisions at the regulatory level are abolished, in fact, in the face of fierce market competition, the requirements for medical representatives are only higher and more comprehensive