搜索
Search

Popular Searches:Medical Instruments    Pharmaceutical Companies   Medical Appliances

Policies & Regulations

Recommended News

Sichuan

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.
Group

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.
The

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.
Reform

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".
The

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.
Notice

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:
Notice

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:
2020

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.
Notice

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:
The

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.
The

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.
Notice

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.
Current Position:
Homepage
/
/
/
Notice of the Sichuan Provincial Drug Administration on Issuing the Measures for the Daily Supervision and Inspection of Drug Clinical Trial Institutions in Sichuan Province

Notice of the Sichuan Provincial Drug Administration on Issuing the Measures for the Daily Supervision and Inspection of Drug Clinical Trial Institutions in Sichuan Province

Notice of the Sichuan Provincial Drug Administration on Issuing the Measures for the Daily Supervision and Inspection of Drug Clinical Trial Institutions in Sichuan Province

All relevant units:

In order to strengthen the daily supervision and management of drug clinical trial institutions in our province, and to ensure the orderly regulation of drug registration research, in accordance with the "Administrative Measures for Drug Registration" (Order No. 27 of the State Administration for Market Regulation) and other regulations, our bureau organized the formulation of the "Sichuan Province The Measures for Daily Supervision and Inspection of Drug Clinical Trial Institutions are hereby issued to you, please follow and implement them.

Sichuan Provincial Drug Administration

May 14, 2020

Daily Supervision and Inspection Measures for Drug Clinical Trial Institutions in Sichuan Province

Article 1 is to regulate the clinical trials of drugs (including vaccines) in Sichuan Province and their daily supervision and inspection activities, in accordance with the "Drug Administration Law of the People's Republic of China", "The People's Republic of China Vaccine Administration Law", "Drug Registration Management Measures" and "Quality Management of Drug Clinical Trials" Regulations and normative documents such as the "Regulations on the Administration of Drug Clinical Trial Institutions" and the "Measures for Ethical Review of Biomedical Research Involving People" are formulated.

Article 2 The daily supervision and inspection referred to in these Measures refers to the routine inspections that the drug regulatory authority implements territorial management requirements and actively implements the compliance of drug clinical trials conducted by drug clinical trial institutions (hereinafter referred to as "institutions").

Article 3 The Sichuan Provincial Drug Administration (hereinafter referred to as the "Provincial Drug Administration") is responsible for the daily supervision and management of drug clinical trial institutions in the province, formulating related management systems in accordance with the law, organizing daily supervision and inspection work, and investigating and investigating violations of laws and regulations.

Article 4 These measures are only applicable to the daily supervision and inspection of the institutions in Sichuan Province that have been filed in accordance with the regulations.

Article 5 In the fourth quarter of each year, the Provincial Food and Drug Administration formulates a daily supervision and inspection plan for the next year and organizes its implementation. In principle, the filing agency arranges daily supervision and inspection once a year.

Article 6 For newly filed institutions or institutions that have been filed for additional clinical trial specialties or address changes, they shall report to the Provincial Food and Drug Administration in writing within 5 working days after the completion of the filing work, and the Provincial Food and Drug Administration shall report 60 cases after filing. Carry out the first supervision and inspection within working days.

Article 7 The person in charge of the institution, the ethics committee of the hospital where the institution is located, etc. shall report the change to the Provincial Drug Administration within 30 working days after the change.

Article 8 Inspections are mainly on-site inspections. In order to further reduce the impact of supervision on the normal order of clinical research, off-site written reviews can also be combined.

Article 9 Based on the risk assessment of the inspected unit, combined with the previous on-site inspection/verification of drug registration by the National Medical Products Administration and the province, if there is one of the following circumstances, the frequency of daily supervision on-site inspection shall be adjusted to half a year or once every quarter:

(1) In the previous year, the institution had an administrative penalty for drug research violations;

(2) In the previous year, during the registration inspection or other due-cause inspections, it was found that the organization had a situation that required follow-up inspection or urged rectification;

(3) Failure to cooperate, evade, or refuse daily supervision and inspection without reasonable reasons.

Article 10 Under any of the following circumstances, daily supervision and on-site inspections in the current year or next year may be exempted, but the institution shall submit a compliance report in accordance with the "Standards for Daily Supervision and Inspection of Drug Clinical Trial Institutions", with supporting materials meeting the exemption requirements :

(1) This year, it has received two or more (including two) on-site registration inspections or due-for-factory inspections by the Drug Administration at the provincial level and above, and no authenticity or other serious violations have been found;

(2) For two consecutive years of daily supervision and inspection, the Provincial Food and Drug Administration did not propose a time limit for rectification.

Article 11 To improve inspection efficiency, on-site inspections are generally notified to the organization in advance. However, a certain percentage of on-site inspections without prior notice are also implemented to facilitate accurate grasp of the true situation of drug clinical trial projects and daily management of institutions.

Article 12 The on-site inspection team implements the leader responsibility system and consists of 2 or more inspectors. The inspection time is generally 1 day. According to work needs, it can be extended appropriately.

Article 13 On-site supervision and inspection procedures are as follows:

(一) The first meeting. Issue the "Notice of Daily Supervision and Inspection of Drug Clinical Trial Institutions" to the inspected unit, and specify the inspection cooperation requirements and inspection work discipline of the institution. In principle, the person in charge of the organization, the person in charge of the organization office, the quality management personnel of the organization and the ethics committee should attend the kick-off meeting.

(2) On-site inspection. According to the "Standards for Daily Supervision and Inspection of Drug Clinical Trial Institutions" and "Standards for Supervision and Inspection of Drug Clinical Trial Institutions after Filing", the inspection team conducts inspections in the form of communication, data review, and on-site inspection, and can obtain and fix relevant evidence material. Institutions should actively cooperate.

(3) The last meeting. Before the end of the inspection, the inspection team formed an inspection opinion and held another meeting on the spot to notify the inspected institution of the inspection situation and preliminary handling opinions. The person in charge of the inspected institution shall sign the inspection opinion form. If there is any objection to the content of the inspection opinion form, it should be raised on the spot and a written explanation shall be made on the inspection opinion form. In principle, the person in charge of the organization should attend the wrap-up meeting.

Article 14 If the on-site inspection team believes that the organization has minor violations that should be warned, the inspection team shall promptly submit warning suggestions to the Provincial Drug Administration, submit evidence of violations, warning reasons, and rectification deadlines, etc., after the inspection is completed. After verification, the Provincial Drug Administration will send a letter ordering the agency to make rectification. The warning letter should be copied to the State Drug Administration, Provincial Health Commission or Provincial Administration of Traditional Chinese Medicine. If the institution fails to make timely rectification as required or the rectification still does not meet the requirements, it shall be transferred to the investigation procedure.

Article 15 If the on-site inspection team believes that the organization has violations of laws and regulations that should be investigated and dealt with beyond warnings, it shall promptly report to the Provincial Food and Drug Administration on the spot, and transfer to the investigation procedure or report to the relevant department for disposal procedures.

Article 16 Institutions shall report the development of drug clinical trials for the current year to the Provincial Drug Administration in writing before December 31 of each year. The report should also comprehensively sort out various inspections based on varieties and institutions carried out by the drug regulatory department, and truthfully report the corrective measures and implementation status for those that require corrections.

Article 17 The Provincial Drug Administration shall establish daily supervision files of the institution, which include the filing status of the institution, the results of routine supervision and inspection, the rectification status, the investigation and punishment of violations of laws and regulations, and bad records. Bad records, etc., will be recorded in the "Credit File and Filing Platform of Drug Clinical Trial Institutions" of the State Drug Administration in a timely manner.

Article 18 If this regulation conflicts or is inconsistent with the follow-up regulations of the State Drug Administration, the regulations shall be implemented.

Article 19 These Measures shall be implemented from July 1, 2020.

Attachment: 1. Daily supervision and inspection work standard of drug clinical trial institutions in Sichuan Province

2. The first supervision and inspection work standard after the registration of the drug clinical trial institution in Sichuan Province

Chuan Drug Administration (2020) No. 84 (Annex)

 

COPYRIGHT © 2020  Sichuan Pharmaceutical Enterprises Import And Export Alliance  All rights reserved

ADD:No. 168, Jianghan Road, Qingyang District, Chengdu City, Sichuan Province     TEL:028-86283398     Email:IEASPE@163.com     Website:www.IEASPE.com

Powered by www.300.cn     蜀ICP备202048596号