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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.
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.
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Notice of the State Food and Drug Administration on Issuing the Regulations on the Administration of Pharmaceutical Processing and Export (for Trial Implementation)

Notice of the State Food and Drug Administration on Issuing the Regulations on the Administration of Pharmaceutical Processing and Export (for Trial Implementation)

Notice of the State Food and Drug Administration on Issuing the Regulations on the Administration of Pharmaceutical Processing and Export (for Trial Implementation)

The Drug Administration of all provinces, autonomous regions, and municipalities directly under the Central Government:

In accordance with the provisions of Article 15 and Article 148 of the "Administrative Measures for Drug Registration", in order to further standardize the administration of drug processing and export, our bureau has formulated the "Regulations on the Administration of Drug Processing and Export (Trial)", which is hereby issued. Complied.

State Food and Drug Administration

July 29, 2003

Pharmaceutical Processing and Export Management Regulations (Trial)

1. In order to standardize the administration of pharmaceutical processing and export, these regulations are formulated in accordance with the provisions of Article 15 and Article 148 of the "Administrative Measures for Drug Registration".

2. The processing and export of pharmaceuticals means that domestic pharmaceutical manufacturers accept the entrustment of overseas pharmaceutical manufacturers in accordance with the law to use domestic or overseas raw materials, excipients, naked packaging preparations or packaging materials, etc., in accordance with their prescriptions, production processes, and quality standards. And packaging and labeling requirements, the process of producing or packaging medicines and exporting them to specific countries or regions. Among them, the export method of processing and exporting raw materials, excipients, naked packaging preparations and packaging materials produced overseas is called processing on orders.

3. The contract signed by both parties of the pharmaceutical processing and export trade shall abide by Chinese laws and regulations and shall not infringe the rights and interests of others. The domestic drug production enterprise that accepts the commission shall strictly follow the production process and quality standards stipulated in the contract, and the commissioning party shall be fully responsible for the quality of the drug.

4. The domestic drug production enterprise that accepts the entrustment shall fill in the "Application Form for Export of Drug Processing" (Annex 1), submit an application to the local provincial drug regulatory authority, and submit the following materials:

(1) The business registration certificate of the foreign pharmaceutical manufacturer in the country where it is located;

(2) A copy of the processing export entrustment agreement or contract;

(3) For processing with supplied materials, a copy of the registration manual for processing with supplied materials approved by the competent national foreign economic and trade department must be submitted;

(4) A copy of the "Drug Production License" of the domestic drug manufacturer that accepts the commission;

(5) The prescription, production process and quality standards of the drug;

(6) The styles of packaging, labels and instructions to be exported;

(7) The number of raw materials or naked packaging preparations to be used and the manufacturer and its address;

(8) When the entrusted domestic drug manufacturer applies for processing export again, it shall explain the export status of the drug approved for processing export last time, and attach relevant copies of invoices, waybills, etc.

5. The provincial drug supervision and administration department will review the application materials, and if they meet the requirements, they will be approved for processing and export, and the "Drug Processing Export Approval Document" (Annex 2) will be issued, and the approval document will be reported to the State Food and Drug Administration for the record.

Six. Raw materials, naked packaging preparations, auxiliary materials and packaging materials required for processing with supplied materials do not need to go through import registration procedures and the "Imported Drug Clearance Form", nor do they need to undergo port quality inspection. The entrusted domestic pharmaceutical production enterprise may directly apply to the customs for the import of materials in accordance with relevant regulations.

Seven. Processing and export must be declared one by one according to the contract period, and the processing and export must be completed within the prescribed time limit. The actual quantity of export preparations processed with supplied materials must be consistent with the quantity of imported raw materials and naked packaging preparations, and the export situation shall be written off by the provincial drug supervision and administration department that originally approved the processing and export after the export is completed.

8. The packaging, labels and instructions of processed and exported drugs must not be all in Chinese, and they must not be printed with the drug approval number or "Imported Drug Registration Certificate" or "Medicine Product Registration Certificate". For medicines exported to Hong Kong, Macau, and Taiwan, the packaging, labels and instructions can use traditional Chinese.

Nine. Raw materials processed with supplied materials and naked packaging preparations and other materials shall not be transferred or used to produce drugs for domestic sale.

10. Preventive biological products shall not accept the entrustment of overseas pharmaceutical manufacturers for processing and export.

Attachment: 1. Application form for export of pharmaceutical processing

2. Pharmaceutical processing export approval

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