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 Comprehensive Department of the State Drug Administration on Issuing the Evaluation Standards for the First Drug Import Port

Notice of the Comprehensive Department of the State Drug Administration on Issuing the Evaluation Standards for the First Drug Import Port

Notice of the Comprehensive Department of the State Drug Administration on Issuing the Evaluation Standards for the First Drug Import Port

Each port (border port) drug supervision and management department:

According to the "Notice of the General Office of the General Office of the General Administration of Food and Drug Administration on Issuing the Appraisal and Assessment Program for the Establishment of Additional Ports Allowed for Drug Imports" (Food and Drug Administration (2015) No. 134), the General Office of the General Administration of Food and Drug Administration The Notice on the Implementation of Evaluation and Assessment Implementation Plan for the Establishment of Additional Drug Import Ports (Food and Drug Administration and Drug Huaguan [2016] No. 150) and other relevant regulations were issued. The State Drug Administration organized the drafting of the "First Drug Import Port Evaluation Standard". To be issued. The port drug supervision and administration department may submit the first drug import port application to the State Drug Administration based on drug import requirements.

National Food and Drug Administration

December 30, 2019

The first drug import port evaluation standard

1. The application for adding the first import port of drugs (excluding medicinal materials) should match the demand. Where a free trade zone has been established in the region or the local government has set up a biomedical industry park, there is a clear plan involving the biomedical industry, and the biomedical enterprises in the region have proposed a clear first-time drug import demand.

2. The port drug inspection agency applying for the first import of drugs should have no less than 3 domestic and foreign experts who can understand and master the latest foreign drug technical standards (such as the World Health Organization, the United States Pharmacopoeia, European EDQM experts, etc., domestic Pharmacopoeia committee members, International GMP inspectors, etc.).

3. The port drug inspection agency applying for the first import of drugs should have research experience in scientific research projects related to national standards. Have research work experience in international drug standards (foreign pharmacopoeia standards) and at least 50 domestic drug standards research work experience (including national pharmacopoeia standards and national drug registration standards).

4. The port drug inspection agency applying for the first import of drugs has participated in the proficiency verification and comparison test organized by domestic authoritative institutions (China National Accreditation Service for Conformity Assessment, China Food and Drug Control Institute, etc.) at least 10 times in the past three years, and participated in international authoritative institutions (World Health Organization, International Pharmaceutical Federation, European Medicines Quality Agency, etc.) organized proficiency testing tests at least 2 times, and all should be satisfactory.

5. The inspection and testing capabilities of the port drug inspection agency applying for the first import of drugs should meet the requirements of drug port inspection and have the ability to cover all items included in the domestic and foreign pharmacopoeia standards. In the past five years, the number of domestic and foreign standards that involved full inspection of various drug inspection tasks was not less than 100, of which the number of imported drug standards was not less than 30 (including port inspection of imported drugs, supervision and sampling, and drug standard review work).

6. The port drug inspection agency applying for the first import of drugs should have independent scientific research capabilities, and the agency should have undertaken relevant research projects at or above the provincial and ministerial level.

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