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
/
/
/
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

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

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

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.

Q: Please briefly introduce the background of the formulation of the Regulations.

Answer: The Party Central Committee and the State Council attach great importance to product quality supervision. General Secretary Xi Jinping pointed out that we must adhere to the principle of quality first and benefit first, with supply-side structural reforms as the main line, and promote economic development quality changes, efficiency changes, and power changes. Premier Li Keqiang emphasized to strengthen supervision and management, improve quality standards, and safeguard the health, safety and legal rights of the people.

Cosmetics are consumer products that meet people's needs for beauty. They directly affect the human body, and their quality is related to the health of the people. In recent years, my country’s cosmetics industry has developed rapidly, but there are also problems such as low industry development quality and efficiency, insufficient innovation capabilities, low brand recognition, and illegal additions. Over the past 30 years since the implementation of the "Regulations on Cosmetic Hygiene Supervision", it has played an active role in promoting the healthy development of the cosmetics industry and ensuring the quality and safety of cosmetics, but it has not been able to meet the needs of industrial development and supervision practices: First, the legislative concept emphasizes pre-approval and government supervision. Failure to highlight the status of the main body of the enterprise and give full play to the role of the market mechanism; second, the supervision method is relatively extensive and does not reflect the concepts of risk management, precise management, and full-process management; third, the legal responsibility is light. Therefore, it is necessary to comprehensively revise the "Regulations on Cosmetics Hygiene Supervision" and formulate a new "Regulations on Cosmetics Supervision and Administration."

Q: Please briefly introduce the formulation process of the Regulations.

Answer: In June 2015, the former Food and Drug Administration submitted the "Regulations on Cosmetics Supervision and Administration (Revision Draft for Review)" to the State Council. The former Legislative Affairs Office of the State Council and the Ministry of Justice have twice solicited opinions from relevant departments, local people's governments, some enterprises and industry associations, and publicly solicited opinions from the public; held several symposiums to listen to the opinions of enterprises and industry associations; went to Shanghai and Zhejiang on site Research. On this basis, the Ministry of Justice, together with the State Administration for Market Regulation and the Food and Drug Administration, have repeatedly studied and revised the draft submitted for review and formed the "Regulations on the Supervision and Administration of Cosmetics (Draft)." On January 3, 2020, the State Council executive meeting reviewed and approved the draft, and on June 16, 2020, the State Council officially promulgated the "Regulations."

Q: What is the general idea of ​​the Regulations?

Answer: The "Regulations" mainly grasp the following points in the overall thinking: First, deepen the reform of "delegating management and service", optimize the business environment, stimulate market vitality, encourage industry innovation, and promote high-quality development of the industry; second, strengthen corporate The main responsibility for quality and safety, strengthen the management of the whole process of production and operation, and strictly observe the bottom line of quality and safety; the third is to implement classified management in accordance with the principles of risk management, scientifically allocate regulatory resources, establish an efficient regulatory system, and standardize regulatory behavior; fourth is to increase penalties for violations Efforts should be made to apply heavy penalties to lawbreakers, expel serious lawbreakers from the market, and create a good development environment for law-abiding persons.

Q: What are the provisions of the Regulations in optimizing the business environment and promoting industrial innovation?

Answer: Implementing the reform requirements of “delegating control and service”, further optimizing the business environment, and promoting industrial innovation and development is an important purpose of the formulation of the Regulations. To this end, the "Regulations" focused on improving the following systems: First, according to the degree of risk, cosmetics are divided into special cosmetics and ordinary cosmetics, and new cosmetic raw materials are divided into new raw materials with higher risks and other new raw materials, and registration and filing are carried out respectively. Management, implement more scientific supervision of products and raw materials. The second is to simplify the registration and filing procedures and optimize services. Strengthen the construction of cosmetics supervision information, improve the level of online government services, and provide convenience for registration and filing; clarify the data requirements and processing time limits for registration and filing, improve transparency and predictability; simplify the filing procedures, and provide for filing through the online government platform The filing will be completed after the information is submitted to avoid disguised approval in practice. The third is to encourage and support cosmetic research and innovation, protect the legitimate rights and interests of units and individuals in conducting research and innovation, and emphasize the encouragement and support of the research and development of cosmetics that combine my country’s traditional advantage projects and characteristic plant resources.

Q: What are the provisions in the Regulations to ensure the quality and safety of cosmetics?

Answer: The overall safety risk of cosmetics is not high, but it directly affects the human body and affects the health of the people. Safety issues cannot be ignored. In order to strengthen the quality management of cosmetics, the "Regulations" focused on improving the following systems: First, the implementation of the main responsibility of the enterprise. It is clear that the registrant and the filing person are responsible for the quality, safety and efficacy claims of cosmetics. The second is to require registrants and recorders to conduct safety assessments on cosmetics and new raw materials. The third is to strengthen the management of production and operation processes. Enterprises are required to organize production in accordance with cosmetics production quality management standards; refine the quality management requirements for production and operation links such as the use of raw materials and packaging materials, incoming inspection and factory inspection, product release, storage and transportation; standardize cosmetics labels and advertising. The fourth is to strengthen the quality and safety control of cosmetics after they are on the market. Registrants and record holders are required to carry out adverse reaction monitoring, timely evaluation and reporting; timely recall of cosmetics that have problems that may endanger human health; implement a safety reassessment system for cosmetics and raw materials.

Q: What are the provisions of the Regulations to improve regulatory measures?

 Answer: The current "Regulations on Cosmetics Hygiene Supervision" was formulated in 1989, and the relevant supervision methods are relatively extensive and do not reflect the concepts of risk management, precise management, and full-process management. The "Regulations" improve the following supervision measures, and strive to improve the scientific, effective, and standardized supervision: First, establish a cosmetics risk monitoring and evaluation system to provide a basis for scientific supervision. The second is to strengthen the standardization of law enforcement and standardize law enforcement measures and procedures. The third is to enrich the supervision methods, stipulate the supervision measures such as sampling inspection, responsibility interview, emergency control, and report rewards, and authorize the drug regulatory department of the State Council to formulate supplementary inspection items and inspection methods. The fourth is to strengthen information disclosure and credit punishment, publish regulatory information in a timely manner, establish credit files, and implement joint punishments on producers and operators with severely bad credit records.

Q: What improvements have been made in terms of legal liability in the Regulations?

Answer: The current "Regulations on Cosmetics Hygiene Supervision" stipulates that the legal liability is relatively light. In recent years, with the rapid development of my country’s cosmetics industry, illegal additions and other illegal phenomena have become more prominent. In order to protect public health and create a good market environment for law-abiding people, it is necessary to increase penalties and severely crack down on illegal activities. The "Regulations" first is to refine the circumstances under which administrative penalties are imposed. According to the nature, circumstances, and degree of harm of the illegal act, strict legal responsibilities are set up. The second is to intensify penalties, comprehensively use confiscation, fines, order to suspend production and business, revoke licenses, market and industry bans, and other penal measures to substantially increase the amount of fines. The third is to add a "punishment to a person" provision, imposing fines on the legal representative or the main person in charge, the directly responsible person in charge, and other directly responsible persons of the unit that seriously violates the law, and it is forbidden to engage in cosmetics production and business activities for a certain period of time until life.

Q: Regarding the situation where the efficacy of cosmetics is arbitrarily exaggerated, what are the regulations in the Regulations?

Answer: The problem of false claims about the efficacy of cosmetics is more prominent, misleading consumers and disrupting market order. To address this issue, the "Regulations" declared the efficacy of cosmetics to establish a management model that focuses on corporate self-discipline and social supervision, and at the same time government departments strengthen supervision during and after the event. The first is to stipulate that the cosmetics registrant or recorder is responsible for the claims of cosmetics. The second is to stipulate that the efficacy claims of cosmetics should have sufficient scientific basis, and the summary of the basis should be disclosed and social supervision should be accepted. Third, it is forbidden for cosmetics labels to express or imply that they have a medical effect. It is forbidden to mark false or misleading contents. Cosmetics advertisements must not deceive or mislead consumers with false or misleading contents. Fourth, corresponding penalties are stipulated in the chapter on legal liability.

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