Drug filing platform to enter the trial phase of information or start uploading.

Pharma Network September 29th All pharmaceutical companies and pharmaceutical representatives note that the preparation of a long-term pharmaceutical representative filing system came the latest progress - the filing platform into the trial stage of the pharmaceutical representative filing system ushered in the latest progress recently, the industry news, on Friday, the Chinese Pharmaceutical Society issued the "notice on the development of pharmaceutical representative filing platform use work" shows that the State Drug Administration will be officially issued in the near future "pharmaceutical representative filing management measures (trial)", the Chinese Pharmaceutical Society and maintenance of the National Drug Administration commissioned by the
From the current information, the construction of the pharmaceutical representative filing platform has been completed, is now in the pharmaceutical representative filing platform trial stage, drug listing license holders can use the account number can log in to the operating interface, the relevant trial opinions can also be further reflected to the Chinese Pharmaceutical Society.
June 5, 2020, the State Drug Administration issued the Measures for the Administration of the Filing of Pharmaceutical Representatives (Trial) (Draft for Comments) to solicit opinions on the measures for the administration of the filing of pharmaceutical representatives. The term "pharmaceutical representative" as used in the
Measures refers to professionals who, on behalf of drug market license holders, engage in drug information transmission, communication and feedback within the territory of the People's Republic of China, whose main duties include: academic promotion, technical advice, assistance to medical personnel in rational drug use, collection and feedback on the clinical use of drugs and information on adverse drug reactions.
medical representatives can carry out academic promotion and other activities through the following forms: over a period of 4 years, whether the first mention of the second consultation, pharmaceutical representatives filing system experienced about 4 years.
, according to Cypress Blue, the filing system for pharmaceutical representatives was first proposed in 2017.
On February 9, 2017, the General Office of the State Council issued "Several Opinions on Further Reforming and Perfecting the Policy on the Production and Circulation of Drugs" calling for the rectification of outstanding problems in the field of drug circulation, such as illegal channels for the purchase and sale of drugs, commercial bribery, price fraud, price monopoly and illegal and illegal violations such as counterfeiting and false infraction.
this request, the document proposes that the food and drug regulatory departments should strengthen the management of pharmaceutical representatives, establish a registration and filing system for pharmaceutical representatives, and make the information available in a timely manner.
medical representatives can only engage in academic promotion, technical advice and other activities, may not undertake the task of drug sales, and their misreponsitable behavior is recorded in the personal credit record.
10 months later, on December 9, 2017, the General Office of the General Administration of Raw Food and Drug Administration and the Office of the former State Health and Planning Commission made public for the first time the Measures for the Administration of the Registration and Filing of Pharmaceutical Representatives (Trial) (Draft for Comments) and solicited opinions.
The first edition of the draft for comments stipulates that medical representatives should be college students (including higher vocational) and above in life sciences, medicine and health, chemical and chemical industries, and if not college (including higher vocational) or above, they should have more than two years of experience in the field of medicine.
three and a half years later, another version of the pharmaceutical representative filing management measures again open for comments, this time, relatively relaxed requirements of the pharmaceutical representative filing system management measures will be formally implemented, worthy of industry attention.
Pharmaceutical enterprises and pharmaceutical representatives are bound by the opinion that drug market license holders as the main responsible person should set post requirements for pharmaceutical representatives - medical representatives should be set academic qualifications and work experience requirements, and pre-job training, set job competency requirements and training subjects (training subjects should include laws and regulations, professional ethics education, medical pharmacy expertise, product-related knowledge, etc.), truthfully record the training situation, to ensure that pharmaceutical representatives meet the requirements of job ability, in line with the relevant regulations.
drug market license holder shall, in accordance with the provisions of these Measures, file a record of the pharmaceutical representative employed or authorized, and enter, change, confirm or cancel the information of his pharmaceutical representative in accordance with the provisions of the filing platform.
after filing, the licensed holder of the drug shall publish on the Company's website the information of the pharmaceutical representative employed or authorized (filing number, company name and code, name, gender, photo, the type of drug responsible for promotion and the therapeutic field, and the date of the start and end of the labor contract).
Under the filing system, the opinion draft stipulates that drug market license holders shall not have the following circumstances: At the same time, medical institutions may not allow unfiliated personnel to carry out academic promotion and other related activities against medical personnel of medical institutions;
does this affect geometry? Regarding the possible impact of the landing of the pharmaceutical representative filing system, a domestic pharmaceutical executive with experience in the work of multinational pharmaceutical companies said to Saibailan that the impact can not be generalized, for some more formal pharmaceutical enterprises, the impact will be smaller, because many enterprises themselves are already in accordance with the relevant compliance requirements of the filing system in carrying out daily work However, for some less compliant pharmaceutical companies, may have some impact, such as some non-compliant CSO companies may not be prepared, due to some non-compliant operations, pharmaceutical companies may not be willing to report the relevant information directly, so that their subsequent in-house promotion may be limited.
, however, what must be seen is how binding the policy is, and how it is implemented by companies.
the above-mentioned people believe that the implementation of the pharmaceutical representative filing system is a trend, do a good job of filing, strengthen management is the general trend, many European and American countries are also so implemented.
In addition, the filing system for the formalization of the practice of pharmaceutical representatives has a certain positive significance, in the actual promotion process, some hospitals a stick killed, directly prohibited medical representatives admitted to hospital, with the implementation of the filing system, may also have a certain impact on this extreme provisions.
On the pharmaceutical representative filing system, Seberan special author Joe Go further told Seberan that the role of the pharmaceutical representative filing system in addition to pre-standard, may also be reflected in the after-the-fact, especially when some pharmaceutical companies pharmaceutical representatives in the hospital promotion problems.
, the turnover rate of medicine representative of this profession is relatively large, whether the filing information can be changed in a timely manner is a matter of concern.
, is in the pharmaceutical representative filing database establishment and information collection stage, follow-up, whether it will derive other management methods is worthy of the concerns of pharmaceutical companies and pharmaceutical representatives.
From a positive point of view, the pharmaceutical representative filing system enhances the formality of the profession, in the context of the hospital clean-up, can improve the hospital representative's practice dignity, to provide a basis for their legal compliance practice, as for non-compliant pharmaceutical representatives and pharmaceutical companies, even if there is no pharmaceutical representative filing system, the elimination of gold sales, commercial bribery policy is also being introduced.
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