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Sichuan Provincial Pharmaceutical Enterprises Import And Export Alliance Held Its Second Sponsor Meeting
2020-05-22

In order to further implement the guiding spirit of the Provincial Party Committee and the Provincial Government on strengthening and regulating the export of epidemic prevention materials, and to promote the effective development of the Sichuan Pharmaceutical Enterprise Import and Export Alliance, the Sichuan Pharmaceutical Enterprise Import and Export Alliance held its second session on the afternoon of May 21, 2020. Sponsor meetings.
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Group to go to sea Sichuan sets up a pharmaceutical enterprise import and export alliance
2020-04-03

On the morning of April 3, the inaugural meeting of the Sichuan Pharmaceutical Enterprises Import and Export Alliance was held in Chengdu. Sichuan Foreign Trade Group, Sichuan Kelun Pharmaceutical, Xinjinshifeng Medical, Mike Biology, Laoken Medical, Tiantian Medical, and Sichuan Branch of the Export-Import Bank of China, as the promoters, jointly signed the alliance agreement, marking the "Sichuan Province The "Import and Export Alliance of Pharmaceutical Enterprises" was formally established.
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The Sichuan Pharmaceutical Enterprises Import and Export Alliance was formally established
2020-04-03

On the morning of April 3, the inaugural meeting of the Sichuan Pharmaceutical Enterprises Import and Export Alliance was successfully held in Chengdu Jinjiang Hotel. Sichuan Foreign Trade Group, Sichuan Kelun Pharmaceutical, Xinjinshifeng Medical, Mike Biology, Laoken Medical, Tiantian Medical, Sichuan Branch of the Export-Import Bank of China, as the initiators, signed the alliance agreement together, marking the "Sichuan Province "Pharmaceutical Enterprise Import and Export Alliance" was formally established, and representatives of key alliance member companies attended the meeting.
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Reform raw material management and encourage technological innovation-the "Regulations" escort the innovation and development of the industry
2020-06-30

The "Regulations on the Supervision and Administration of Cosmetics" (hereinafter referred to as the "Regulations"), which has attracted much attention from the industry, is finally released! Compared with the "Regulations on Cosmetics Hygiene Supervision" promulgated in 1989, the contents of the "Regulations" have many new changes. Among them, the classification and management of new raw materials and the encouragement of technological innovation are undoubtedly a highlight of the "Regulations".
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The heads of the Ministry of Justice, the State Administration of Market Supervision, and the Food and Drug Administration answer reporters’ questions on the Regulations on Supervision and Administration of Cosmetics
2020-06-29

On June 16, 2020, Premier Li Keqiang signed the State Council Order No. 727, promulgating the "Regulations on Supervision and Administration of Cosmetics" (hereinafter referred to as the "Regulations"). The "Regulations" shall come into force on January 1, 2021. A few days ago, the heads of the Ministry of Justice, the State Administration of Market Supervision, and the Food and Drug Administration answered questions from reporters on related issues in the Regulations.
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Notice of the Comprehensive Department of the State Food and Drug Administration on matters concerning the registration of licensed pharmacists in deeply impoverished areas such as "three regions and three states"
2020-06-24

In accordance with the "Notice of the General Office of the Ministry of Human Resources and Social Security on Matters Concerning the Separate Delineation of Vocational Qualification Examination Standards for Nurses in Deeply Poverty Areas such as the "Three Districts and Three States" (for Trial Implementation)" (Human She Ding Fa [2019] No. 77) It is required that those who have registered for the vocational qualification examination for licensed pharmacists in the corresponding cities, districts, and states in the "three districts and three states" and other deeply impoverished areas have not met the national qualification standards, but within the prescribed period of validity of the examination results, all subjects have reached the city, District and state qualified standards, you can apply for a valid local professional qualification certificate. In order to standardize the registration and approval of the professional qualifications of licensed pharmacists in deeply impoverished areas such as the "three districts and three states", and to further strengthen the construction of the team of licensed pharmacists in deeply impoverished areas such as the "three districts and three states", the relevant matters are hereby notified as follows:
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Notice of the Sichuan Provincial Drug Administration on Launching Special Rectification Actions for Drug Online Sales Violations
2020-06-01

In order to further standardize drug online sales activities, severely crack down on illegal drug online sales, and effectively guarantee the safety of public medication, according to the "Notice on Launching Special Rectification Actions for Drugs Online Sales" (Drug Administration Comprehensive Drug Guan (2020) No. 35) requires that from now to October this year, special rectification of illegal drug online sales will be carried out across the province. The relevant matters are hereby notified as follows:
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2020 Medical Device "Clear Network" Action Work Plan
2020-05-29

In order to strengthen the supervision of online medical device sales, thoroughly implement the "four strictest" requirements for drug safety, fully implement the "Measures for the Supervision and Administration of Medical Device Online Sales" and "Administrative Measures for Internet Drug Information Services", and further strengthen medical device online transaction services The management responsibility of the third-party platform (hereinafter referred to as the third-party platform) and the main responsibility of the medical device online sales enterprise (hereinafter referred to as the online sales enterprise), regulate the order of medical device online marketing, severely punish all kinds of violations of laws and regulations, and ensure the safety of the masses in the use of equipment. To save the actual situation, formulate this plan.
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Notice of the Comprehensive Department of the State Drug Administration on Doing a Good Job in the Supervision and Administration of Drug Exports During the Period of Epidemic Prevention and Control
2020-04-03

The Drug Administration of all provinces, autonomous regions, and municipalities directly under the Central Government, and the Drug Administration of Xinjiang Production and Construction Corps:
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The General Administration of Market Supervision announced the "Measures for the Administration of Drug Registration" and "Measures for the Supervision and Administration of Drug Production"
2020-03-30

On March 30, the State Administration for Market Regulation announced the "Administrative Measures for Drug Registration" by Order No. 27 of the General Administration and the "Administrative Measures for the Supervision and Administration of Drug Production" by Order 28. The two regulations will be officially implemented on July 1, 2020.
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The State Food and Drug Administration issued 5 standards including the "Basic Data Set for Drug Marketing Authorization Holders and Manufacturers"
2020-03-11

On March 6, 2020, the National Food and Drug Administration issued the "Basic Traceability Data Set for Drug Marketing Authorization Holders and Manufacturers", "The Traceability Basic Data Set for Drug Dealers", "The Traceability Basic Data Set for Drug Use Units", and "Drug Traceability to Consumers" Inquire about 5 standards including Basic Data Set, Basic Technical Requirements for Drug Traceability Data Exchange. In addition to the previously issued "Guidelines for the Construction of Drug Information Traceability System", "Drug Traceability Code Coding Requirements", "Basic Technical Requirements for Drug Traceability Systems", "Vaccine Traceability Basic Data Set", and "Vaccine Traceability Data Exchange Basic Technical Requirements", etc. Standards. So far, the 10 drug traceability standards compiled by the State Drug Administration have all been released and implemented.
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Notice of the Comprehensive Department of the State Food and Drug Administration on Carrying out the Special Inspection Work of Nationally Organized Drug Centralized Procurement and Use
2020-03-10

In order to further implement the decision and deployment of the Party Central Committee and the State Council on the state-organized centralized procurement and use of drugs, strengthen the quality supervision of the centralized procurement and use of selected drugs, and effectively ensure the safety of the people's medication. The State Food and Drug Administration has decided to conduct special inspections on selected drugs for the centralized procurement and use of drugs organized by the state. The relevant matters are hereby notified as follows:
The

The Sichuan Pharmaceutical Enterprises Import and Export Alliance held a communication and coordination meeting
2020-03-27

On March 26, the Sichuan Pharmaceutical Enterprises Import and Export Union held a preparatory work meeting. The principals of the seven alliance sponsor units including Sichuan Foreign Trade Group, Sichuan Kelun Pharmaceutical, and Chengdu Xinjinshifeng attended the meeting.
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Notice of the Sichuan Provincial Drug Administration on Launching Special Rectification Actions for Drug Online Sales Violations

Notice of the Sichuan Provincial Drug Administration on Launching Special Rectification Actions for Drug Online Sales Violations

Notice of the Sichuan Provincial Drug Administration on Launching Special Rectification Actions for Drug Online Sales Violations

All municipal (prefecture) market supervision administrations, relevant departments, inspection branches and directly affiliated units of the provincial bureaus:

In order to further standardize drug online sales activities, severely crack down on illegal drug online sales, and effectively guarantee the safety of public medication, according to the "Notice on Launching Special Rectification Actions for Drugs Online Sales" (Drug Administration Comprehensive Drug Guan (2020) No. 35) requires that from now to October this year, special rectification of illegal drug online sales will be carried out across the province. The relevant matters are hereby notified as follows:

1. Work goals

Guided by Xi Jinping’s thoughts on socialism with Chinese characteristics in the new era, with the implementation of the "Drug Administration Law" and the "Four Strict" requirements of drug supervision as the main line, in accordance with the "online and offline principle", through in-depth development of drug online sales Special rectification of violations of laws and regulations, strict investigation and punishment of violations of laws and regulations, supervision of drug online sales as an emerging business format to continue to operate in compliance, maintain the order of drug online sales, adhere to the bottom line of drug quality and safety, and promote high-quality development of the industry.

2. Key points of remediation

(1) Selling fake and inferior drugs through the Internet;

(2) Engaging in online drug sales without obtaining the qualification for drug production and operation;

(3) Selling vaccines, blood products, narcotic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs, pharmaceutical precursor chemicals, and other drugs subject to special management through the Internet;

(4) Selling drugs without drug approval documents through the Internet;

(5) Illegal sales of medical institution preparations through the Internet;

(6) Selling prescription drugs without conducting prescription review and dispensing according to regulations;

(7) The third-party platform fails to strictly perform the qualification review obligations, and does not manage the business activities that occur on the platform;

(8) Do not possess the "Internet Drug Information Service Qualification Certificate" to provide drug network information services;

(9) Other illegal activities of online drug sales.

3. Organizational leadership

(1) The Provincial Drug Administration has established a special rectification leading group for drug online sales, responsible for the overall deployment of special rectification actions across the province, and investigate and deal with violations of laws and regulations in accordance with the law. The leader in charge serves as the team leader, and the main persons in charge of the Drug Circulation Supervision Office, the Drug Production Supervision Office, the Administrative Approval Office, and the inspection branches of the districts serve as members. among them:

The Drug Circulation Supervision Office is responsible for the special rectification and lead work, using the national drug network transaction monitoring system and other channels to collect clues on drug network sales violations and timely transfer according to the division of responsibilities at all levels.

The Administrative Approval Office strengthened the management of administrative licenses and strictly reviewed and issued the "Internet Drug Information Service Qualification Certificate."

Drug Production Supervision Office, Drug Circulation Supervision Office, and district inspection sub-bureaus, combined with daily supervision and inspection, supervise and inspect drug manufacturers, drug wholesale companies, and third-party platforms according to their duties, and investigate and deal with violations of laws and regulations.

(2) The municipal (prefecture) market supervision bureaus are responsible for supervising and inspecting pharmaceutical retail enterprises and other units within their jurisdiction, and investigating and punishing clues that violate laws and regulations.

4. Work measures

(1) Carry out business registration and master basic information.

Drug regulatory authorities at all levels shall supervise and urge drug network sales enterprises within their jurisdiction to register and master the basic information. Third-party platforms, production, and wholesale companies that carry out online drug sales should fill in the "Sichuan Province Drug Online Sales Enterprise Registration Form" (Attached Table 1), and report to the Drug Circulation Supervision Division of the Provincial Drug Administration for registration before June 12. The municipal (prefecture) market supervision bureaus should arrange for the registration of retail pharmacies that carry out online sales of drugs, and form a summary table (Attached Table 2) and submit it to the provincial bureau before June 19. The provincial bureau will collect the list of enterprises that have obtained the qualification certificate for Internet drug information services in the whole province and distribute it to each city (state) separately.

(2) Carry out self-examination and verification and strengthen supervision measures.

Drug regulatory authorities at all levels should supervise and urge enterprises to conduct self-inspection and self-inspection according to the key points of rectification, to conduct immediate investigations and reforms, and make improvements while investigating to ensure that investigations and rectifications are in place. It is necessary to organically integrate the special rectification task of online drug sales with annual supervision and inspection, carry out special rectification in the supervision and inspection, and strengthen the effect of supervision and inspection with the in-depth special rectification, and standardize the behavior of drug online sales. Comprehensive use of administrative interviews, administrative penalties and other means to urge third-party platforms and drug online sales companies to fulfill their statutory responsibilities and obligations, and strictly implement a traceability system for transaction records.

(3) Strengthen case investigation and crack down on illegal acts.

Adopt a combination of online clue collection and offline investigation and disposal, strengthen "offline" in-depth investigation of illegal clues discovered through "online" monitoring, mass reporting, etc., and seriously investigate and deal with illegal drug online sales. Conduct and publicly investigate and deal with the situation in accordance with the law; if the product involved in the case is found to flow to other areas, it should be reported to the local supervisory department in time to trace the source; if clues to a major illegal case are found, it should be reported to the higher-level supervisory department in time. It is necessary to investigate and deal with a number of typical cases to form an effective deterrent and effectively maintain the order of drug online sales.

5. Work arrangement

  The special rectification was carried out in three stages:

(1) Mobilization and deployment phase: April to June 2020. The Provincial Food and Drug Administration issued a work notice to conduct extensive mobilization and deployment and policy publicity for special rectification. In accordance with the special rectification requirements, the enterprise actively carried out self-examination and carried out in-depth rectification. Pharmaceutical production and operation companies and third-party platforms that carry out pharmaceutical online sales must implement the main responsibility for quality management, improve systems, strengthen management, and strictly self-discipline in accordance with relevant legal requirements.

(2) Centralized renovation phase: May to September 2020. In contrast to the key tasks of rectification, a combination of "online" clue collection and "offline" investigation and disposal was adopted to carry out centralized rectification of illegal drug online sales. The State Food and Drug Administration will transfer monitoring clues to relevant provinces through the national drug network transaction monitoring system, and the Provincial Food and Drug Administration will collect clues and organize investigations and disposals according to their duties. Drug regulatory authorities at all levels should combine this special rectification with the annual inspection plan and daily work, and make overall arrangements for inspection tasks.

(3) Summary and improvement stage: October 2020. Drug regulatory authorities at all levels should summarize inspections in a timely manner, summarize the staged effects and experience of special rectification, find existing problems, continue to maintain a high-pressure situation of cracking down on illegal drug online sales, and consolidate the results of special rectification.

Six, job requirements

(1) Strengthen organizational leadership. Drug regulatory agencies at all levels should improve their ideological understanding, adhere to the people-centered regulatory concept, adhere to the standardization of drug online sales and ensure drug quality and safety, based on local reality, detailed work arrangements, meticulous organization, and effective special rectification Standardize drug online sales and improve drug safety assurance.

(2) Strengthen communication and coordination. Drug regulatory departments at all levels should establish and improve a drug online sales complaint reporting system to guide and strengthen social co-governance. It is necessary to strengthen inter-departmental coordinated supervision and joint disciplinary action, so that offenders "break the law in one place, and restrict the punishment." In the process of investigating cases, involving other regions and departments, it is necessary to proactively contact, communicate in a timely manner, strengthen cooperation, and form a joint force to jointly combat violations of laws and regulations. Involving cross-province and cross-regions, we must establish a "game of chess" to ensure the smooth progress of the investigation; suspected crimes must be promptly transferred to the public security organs in accordance with the procedures; for website closure or blocking matters, communication with the industry and information departments must be strengthened.

(3) Strengthen and discuss guidance. Drug regulatory authorities at all levels must give full play to the role of the media, collect and dispose of online public opinion information in a timely manner, increase exposure to illegal online drug sales, publish typical cases, deter criminals, and warn and educate the public. It is necessary to combine various safe drug publicity activities, use newspapers, magazines, radio and television, websites, WeChat official accounts and other news media and various media to carry out online drug safety knowledge publicity, and create a good public opinion atmosphere for the development of special rectification.

Each city (prefecture) market supervision bureau and each inspection branch shall summarize the rectification situation in a timely manner, and sort out the number of enterprises in the jurisdiction, the development of this special rectification, existing problems, work suggestions, etc. before October 20, 2020, and summarize them. Work summary, fill in the special rectification work statistical table (Annex 2) and submit it to the Drug Circulation Supervision Department of the Provincial Drug Administration.

Contact: Li Ya, Tel: 028-86785790, Email: 907239794@qq.com.

Attachment: 1. Registration Form of Sichuan Pharmaceutical Network Sales Enterprise

2. Summary table of online drug sales companies

3. Statistical table for special rectification of illegal drug online sales

Chuan Drug Administration (2020) No. 88 (Annex)

Sichuan Provincial Drug Administration

June 1, 2020

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