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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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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"

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"

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"

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 quality and safety of medicines are closely related to the health of the people. General Secretary Xi Jinping emphasized that the responsibility for drug safety is more important than Mount Tai, and requires that the supervision of drug quality and safety be strengthened in accordance with the "four strictest". Premier Li Keqiang called for the establishment of the strictest drug safety supervision system. The Party Central Committee and the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices" (Ting Zi [2017] No. 42) and other important documents to make major reform arrangements for the drug review and approval system. In June 2019, the Standing Committee of the National People's Congress deliberated and passed the Vaccine Management Law; in August, it deliberated and passed the newly revised Drug Management Law. In accordance with the latest requirements of the two laws, the State Food and Drug Administration has stepped up the revision and drafting of supporting regulations such as the Measures for the Administration of Drug Registration and the Measures for the Supervision and Administration of Drug Production, and submitted the revised drafts of the two regulations for review on November 29 The draft is submitted to the State Administration for Market Regulation for review.

The Party Group of the State Administration for Market Regulation and the Party Group of the State Food and Drug Administration earnestly implement the decisions and deployments of the Party Central Committee and the State Council on drug and vaccine regulatory reforms, adhere to the rule of law to build consensus on reforms, promote various reforms and innovations in the drug sector on the track of the rule of law, and implement new formulations The latest requirements of the “Vaccine Administration Law” and the newly revised “Drug Administration Law”, in accordance with the “Legislative Law”, “Regulations on the Procedure of Regulations” and “Regulations on the Procedure of Regulations of the State Administration for Market Regulation”, the drafts of the two regulations were submitted for review. Reviewed and revised. In the process of drafting and review, adhere to the requirements of scientific legislation, democratic legislation, and law-based legislation, and extensively listen to opinions and suggestions. In view of the key and difficult issues in the revision, experts are specially organized to evaluate and fully conduct research and demonstration. On January 15, the first administrative meeting of the General Administration of China in 2020 reviewed and approved the above two regulations.

The basic ideas followed in the drafting and revision process: First, adhere to the "four strictest." Strict drug registration management and drug production supervision, strengthen supervision of the whole process, strictly prevent and control drug quality and safety risks, and firmly maintain the bottom line of public safety. The second is to deepen reform and innovation. Fully implement the marketing authorization holder management system, encourage drug innovation, continue to optimize the drug registration review and approval system and the drug production license system, and build a scientific and efficient review and approval process. The third is to highlight the problem orientation. Adhere to the people-centered approach, learn from the practical experience of international supervision, and combine with domestic supervision practices to focus on solving outstanding problems in drug registration and drug production supervision. The clinically urgently needed drugs, drugs for children, drugs for rare diseases, drugs for major infectious diseases, and diseases Vaccines urgently needed for prevention and control and innovative vaccines are clearly included in the scope of accelerated listing and registration. Put forward clear requirements for continuous compliance in drug production. The fourth is to strengthen the implementation of responsibilities. Strictly implement the main responsibility and supervisory responsibility of enterprises, refine the obligations of drug development, registration, and production, and clarify the division of powers and supervision and inspection requirements of the supervisory department.

The main contents of the amendments include: First, fully implement the drug marketing authorization holder system. It is clear that the applicant is an enterprise or drug research and development institution that can bear corresponding responsibilities, and requires the establishment of a drug quality assurance system, management of the entire life cycle of the drug, post-marketing research, and responsibility for the safety, effectiveness and quality of the listed drug. The second is to optimize the review and approval workflow. Do a good job in the connection of drug registration acceptance, review, verification and inspection, change the original review, verification and inspection from "series" to "parallel", establish breakthrough therapeutic drugs, conditional approval, and priority review The four accelerated channels for approval and special approval have clarified the review time limit, and improved the efficiency of drug registration and the expectation of the registration time limit. In accordance with the principles of risk management, the requirements of “delegation, management and service” were implemented, and classified management of changes was implemented. The third is to implement full life cycle management requirements. Strengthen drug development, registration and post-marketing supervision. Increase the supervision of drug non-clinical research institutions, drug clinical trial institutions and relevant requirements for drug safety credit files. Pay attention to the organic connection between registration and production license, implement the regulatory requirements of drug production quality management, clarify inspection procedures and follow-up measures for inspection results. Actively promote social co-governance, require public review conclusions and basis, and accept social supervision. The fourth is to strengthen accountability. Refine penalties, severely crack down on data fraud and other violations of laws and regulations, and create a good environment that encourages innovation.

As the core supporting regulations in the field of drug supervision, the revision of the two regulations will lay a legal foundation for strengthening drug quality and safety risk control, standardizing and strengthening drug supervision, and ensuring drug safety, effectiveness and quality control. In the next step, the State Food and Drug Administration will promptly formulate supporting documents to ensure that various regulations are implemented, effectively improve the quality of drugs, and ensure that drugs are safe, effective, and accessible.

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