Heavy weight, drug filing system to start again!

Introduction: On June 5, the State Drug Administration issued the Measures for the Administration of the Record of Pharmaceutical Representatives (Trial) (Draft for Comments)June 5, the State Drug Administration again issued the "Pharmaceutical Representative For-Record Management Measures (Trial) (Draft for Comments)", a total of 18 drafts for comments, as of June 19, and the state drug regulatory agency last solicited opinions on the record-keeping system of pharmaceutical representatives at the end of 2017compared to the 2017 draft, there are many changes in this year's draft:, there is a change in the definition of pharmaceutical representatives
the 2017 edition of the paper refers to the pharmaceutical licensing holders (companies holding drug approval numbers, the same below) in the People's Republic of China engaged in drug information transmission, communication, feedback professionalsImported drug distributors may act on behalf of overseas drug listing license holders responsible for the registration and record-keeping of pharmaceutical representativesPharmaceutical sales personnel do not belong to the pharmaceutical representative and shall not be included in the management of these Measuresthe 2020 edition is reduced to: The term "pharmaceutical representative" as mentioned in these Measures refers to professionals who are engaged in the transmission, communication and feedback of pharmaceutical information on behalf of the holder of the drug market license in the People's Republic of Chinathe author believes that the definition behind the simplification is broader, agents, CSO in the traditional sense, belongs to the pharmaceutical sales staff, but will now also be summarized as pharmaceutical representativesThat means that sales are a matter for distributors, and doctors communicate and communicate, can only be a role of medical representatives, will promote the return to academia, divestment of the sales partin the duties of the pharmaceutical representative, the 2017 and 2020 editions are no different, are academic promotion, technical advice, to assist medical personnel to rational use of drugs, collection, feedback on the clinical use of drugs and adverse drug reactioninformationmedical representatives may conduct academic promotion and other forms of activities are no different:(i) communicate with medical personnel in person with medical institutions,(2) hold academic conferences and lectures,(iii) provide academic materials,(4) communicate through the Internet or teleconferences, and other forms agreed by(5) medical institutions, remove professional restrictions, focusing on pre-job training
the 2017 edition of the pharmaceutical representative professional requirements, or for medicine, life sciences and other related professional, or non-medical medicine majors, but college or above has 2 years of experience in the field of medicinethe 2020 edition does not agree on a professional or working life, but requires pharmaceutical companies to have requirements for representative academic qualifications and work experience and to conduct pre-job training3Pharmaceutical companies must make public the information for the filing of pharmaceutical substitutes
the 2020 edition of the added content is that, after the state drug regulatory agency designated the drug generation platform for the record, pharmaceutical companies must also be in the official website or industry association (no company official website) to the pharmaceutical representative of the enterprise to open, the 2017 version of the content for the record information to be verified with medical institutionsclearly, the 2020 edition will reduce the workload of medical institutions, but for companies, especially competitors, it is time to keep a close eye on their competitors4Drug generation does not back sales tasks, not all parties, donations, sponsorships for individuals and business departments
2020 edition and 2017 edition are very consistent is that pharmaceutical representatives can not undertake sales tasks, collection and processing of purchase and sale bills, may not be unified, induced doctors to use drugs, exaggerated or misleading efficacy, conceal ingenuity of the drug known adverse reaction information or conceal the adverse reaction information of doctors, at the same time prohibited to provide donations to hospitaldepartments and individualsThe Measures for the Administration of the Record of Medical Representatives (Trial)(Draft for Comments)Article 1 To regulate the conduct of pharmaceutical representatives and promote the healthy and orderly development of the pharmaceutical industry, according to the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of the Review and Approval System to Encourage Innovation of Pharmaceutical Medical Devices (No42 of the Office of the State Council and the Opinions of the General Office of the State Council on Further Reform ingesting and improving the policy on the use of pharmaceutical production and circulation(No13)Article 2 of the The term "pharmaceutical representative" as mentioned in these Measures refers to a professional who represents the holder of a drug market license in the territory of the People's Republic of China in the transmission, communication and feedback of drug information, and its main duties include: academic promotion, technical consultation, assistance to medical personnel to rational use of drugs, collection and feedback on the clinical use of drugs and information on adverse drug reactions article 3 Medical representatives may carry out academic promotion and other activities through the following forms: (1) communicating with medical personnel in person with medical institutions, (2) holding academic conferences and lectures, providing academic materials (3), (4) communicating through the Internet or teleconferences; and (5) other forms agreed by medical institutions Article 4 The holder of a drug listing license shall sign a labor contract or authorization letter with the pharmaceutical representative, set the educational qualifications and work experience requirements for the pharmaceutical representative, conduct pre-job training, set the post capacity requirements and training subjects, record the training situation truthfully, and ensure that the pharmaceutical representative meets the requirements of the post ability and conforms to the relevant regulations of the profession training subjects shall include laws and regulations, professional ethics education, medical pharmacy expertise, product-related knowledge and so on drug licensing holders may entrust social institutions with training and be responsible for the authenticity of the training records Article 5 The holder of a drug listing license shall file the information of the pharmaceutical representative on the filing platform designated by the state drug regulatory department filing platform may check and check the information of the pharmaceutical representative, make public the information of the drug listing license holder or the pharmaceutical representative for breach of trust and violation of the law, issue notice announcements, policies and regulations, and provide public inquiries the filing platform is entrusted by the State Drug Administration to build and maintain the China Pharmaceutical Society Article 6 The holder of a drug listing license shall, in accordance with the provisions of these Measures, record the pharmaceutical representatives employed or authorized, and enter, change, confirm or cancel the medical representative information of his or her in accordance with the provisions of the filing platform Article 7 The holder of a drug listing license shall submit the following filing information on the filing platform: (1) the name of the drug market license holder and the unified social credit code; (2) the name, sex and photograph of the pharmaceutical representative; (3) type and number of identity documents, professional and educational qualifications, (4) date of start and end of the labor contract or authorization; (5) the pharmaceutical representative is responsible for promoting the drug category and treatment field, etc.; (6) the the authenticity of the drug listing information; after submitting the filing information, the filing platform automatically generates the record for the record Article 8 The holder of a drug listing license shall publish information on the pharmaceutical representative employed or authorized on the website of the Company If the Company does not have a website, it shall be published on the website of the relevant trade association article 9 The holder of a drug listing license shall make public the following information: (1) the record number of the pharmaceutical representative; (2) the name of the holder of the drug listing license, the unified social credit code, the name, sex and photo of the pharmaceutical representative (3), the type of drug and the treatment area for which the (4) the pharmaceutical representative is responsible for the promotion, etc.; and the start and end date of the (5) the labor contract or authorization Article 10 If the record information of the pharmaceutical representative changes, the holder of the drug listing license shall complete the change of the filing information within 30 working days and change the information published on the website simultaneously the holder of the drug market license shall cancel the filing information of the pharmaceutical representative who ceases to engage in the relevant work or ceases to be authorized Article 11 If a drug marketing license holder is revoked, revoked or cancels the Drug Production License, he shall cancel the information of the pharmaceutical representative for which he has filed within 30 working days after the administrative organ has made an administrative penalty or administrative decision Article 12 The activities of medical representatives in medical institutions shall be carried out in public and the relevant provisions of the health and health departments shall be observed After obtaining the consent of the medical institution, it may carry out academic promotion and other activities with its medical personnel article 13 The holder of a drug listing license shall not: (1) encourage or imply that the pharmaceutical representative engages in illegal and illegal acts; (2) assign the pharmaceutical representative the task of drug sales, require the pharmaceutical representative to collect and process the purchase and sale of bills; (3) require the pharmaceutical representative or other personnel to count the quantity of prescriptions of medicines issued by the physician; and (4) provide false information in the filing article 14 Medical representatives shall not have the following circumstances: (1) carry out academic promotion and other activities without the consent of medical institutions; (2) undertake drug sales tasks, collect and process purchase and sale bills; (3) participate in the counting of the number of prescriptions of drugs issued by individual doctors; (4) directly provide donation sispent on medical institutions; (5) misleading doctors about the use of drugs, exaggerating or concealing information about adverse drug use, and concealing information about adverse drug use the holder of a drug listing license shall strictly perform the management responsibilities of the pharmaceutical representative employed or authorized, and it is strictly prohibited for the pharmaceutical representative to have the above-mentioned circumstances For pharmaceutical representatives who have the above-mentioned circumstances, the holder of the drug listing license shall correct them in a timely manner; if the circumstances are serious, they shall be suspended from carrying out academic promotion and other activities, and shall provide on-the-job training Article 15 If the holder or pharmaceutical representative of a drug market license gives property or other improper interests to the person in charge of a medical institution, a pharmaceutical purchaser, a physician or pharmacist who uses his medicine, he shall conduct an investigation and deal with the relevant laws and regulations of the Drug Administration Law of the People's Republic of China and the Anti-Unfair Competition Law of the People's Republic of China Article 16 Medical institutions shall not allow unfiled personnel to carry out academic promotion and other related activities on medical personnel of this medical institution; Article 17 Social institutions such as trade (learning) associations shall actively play the role of industry supervision and self-discipline, and social institutions such as industry (learning) associations shall be encouraged to formulate industry norms and their codes of conduct in accordance with these Measures, and establish supervision mechanisms, credit rating management mechanisms and joint incentives and punishment measures article 18 of the , these Measures shall come into effect from the month of 2020 attached: Medical representative filing information sheet (style)