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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.
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.
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 Office of the Sichuan Provincial Drug Administration on Issuing the Implementation Plan for the Quality Supervision and Sampling Inspection of Sichuan Pharmaceutical Packaging Materials in 2020
2020-05-11

Municipal (prefecture) Market Supervision Administration, Provincial Food and Drug Inspection and Testing Institute:  
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:
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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

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

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

Drug Administration Comprehensive Drug Administration (2020) No. 31

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:

In order to implement the decision and deployment of the Party Central Committee and the State Council, strengthen the supervision and management of drug export quality during the epidemic prevention and control period, promote the facilitation of drug export, promote the high-quality development of China's pharmaceutical industry, and effectively maintain the image of manufacturing in China, the relevant requirements for strengthening drug export supervision and management are hereby notified as follows :

1. Strictly regulate the management of drug export certification

The provincial drug regulatory authorities shall comply with the "Drug Administration Law" and other laws and regulations and the former Food and Drug Administration's "Notice on Matters Concerning the Export of EU API Documents" (SFDA [2013] No. 10) and the State Food and Drug Administration The "Notice on the Administration of the Issuance of Pharmaceutical Export Sales Certificates" (Guoyao Jian Yao Guan [2018] No. 43) and other relevant regulations strictly regulate the export of EU APIs, certificates of export sales of drugs, anabolic preparations and peptide hormone exports Issuance and management of drug export certificates such as permits. Relevant drug regulatory authorities must comprehensively investigate the status of the certificate. For those who do not meet the certification conditions and requirements, and fail to comply with my country's Good Manufacturing Practice (GMP), the relevant drug export certificate shall be cancelled in accordance with the law. Do a good job in daily supervision after the State Food and Drug Administration has issued an import and export permit for narcotic drugs and psychotropic drugs.

2. Continue to strengthen drug production supervision

All provincial drug regulatory authorities should strengthen the supervision of drug marketing license holders and drug manufacturers in their administrative regions, urge the holders and drug manufacturers to organize production in strict accordance with drug laws and regulations and drug GMP, and urge companies to ensure that they export drugs The quality meets the requirements of the importing country, strengthens the legal awareness, strictly fulfills the contractual agreement, and properly responds to various risks. We must severely crack down on all types of violations of laws and regulations in the pharmaceutical production process, and take special measures. For violations involving supervision of other departments, they shall be promptly transferred to relevant departments for handling and notification; for suspected crimes, they shall be promptly transferred to public security organs.

3. Strictly implement the responsibilities of all parties

Drug marketing license holders and drug manufacturers who are responsible for drug quality and safety in accordance with the law shall strictly abide by the provisions of China's drug laws and regulations, and organize production in accordance with the technical standards of the importing country to ensure that their exported drugs meet the standards of the importing country (region) or Contract requirements. Under the leadership of the local party committee and government, the drug regulatory agencies at all levels should strengthen unified leadership, strengthen information reporting, and work closely with relevant departments according to their responsibilities, strive to form a good situation of multi-departmental joint management and social governance, and comprehensively promote drugs Standardized export management and healthy development.

Fourth, do a good job in resuming work and production related services

All provincial drug regulatory agencies shall, in accordance with the relevant arrangements of the Party Central Committee and the State Council, do a good job in the resumption of work and production of drug manufacturers during the epidemic prevention and control period. Do a good job in the management of drug export certification documents in accordance with their duties, improve internal processing procedures, reduce the processing time limit, promote online acceptance and certification, and make drug export certification data information public, and continue to facilitate the export of enterprises. It is necessary to organize investigations and coordinate to solve the problems and difficulties faced by enterprises in exporting drugs, report to the local people's government when necessary, and promptly notify relevant departments to study and solve them.

All provincial drug regulatory agencies should further improve their political positions, timely convey the spirit of this notice to drug export companies and industry associations in their administrative regions, strive to supervise and manage drug exports during the epidemic prevention and control period, and actively support the international community. Fight the epidemic.

National Food and Drug Administration

April 3, 2020

Previous: 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"
Next: 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"
Previous: 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"
Next: 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"

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