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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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Reform raw material management and encourage technological innovation-the "Regulations" escort the innovation and development of the industry

Reform raw material management and encourage technological innovation-the "Regulations" escort the innovation and development of the industry

Reform raw material management and encourage technological innovation-the "Regulations" escort the innovation and development of the industry

The "Regulations on the Supervision and Administration of Cosmetics" (hereinafter referred to as the "Regulations"), which has attracted much attention from the industry, has finally been issued! Compared with the "Regulations on Cosmetics Hygiene Supervision" issued in 1989, the contents of the "Regulations" have undergone many new changes. The classification and management of raw materials and the encouragement of technological innovation are undoubtedly a highlight of the "Regulations".

1. The "Regulations" implement classified management of cosmetic raw materials, especially new raw materials, and set a monitoring period for new raw materials

(1) Implement classified management of cosmetic raw materials according to risk differences. Many contents of the "Regulations" involve the management of raw materials, dividing cosmetic raw materials into new raw materials and used raw materials, including clear classification management of cosmetic raw materials according to the degree of risk, and registration or filing of new raw materials according to the degree of risk Management, the drug regulatory department of the State Council formulates a list of prohibited raw materials. The "Regulations" clearly stated that new cosmetic raw materials with antiseptic, sunscreen, coloring, hair dyeing, spot-removing and whitening functions can only be used after registration by the State Council's drug regulatory authority; other new cosmetic materials should be filed with the State Council's drug regulatory authority before use. The recorder of new cosmetic raw materials shall complete the record after submitting the record materials stipulated in these Regulations through the online government service platform of the drug regulatory department of the State Council.

The above-mentioned contents of the "Regulations" refine new cosmetic raw materials based on risk differences and implement classified management, that is, register and manage high-risk raw materials such as preservatives, sunscreens, colorants, hair dyes, and freckle whitening agents. Other ordinary new raw materials with relatively low risks no longer require administrative approval and are changed to record management. The recorder can use it after completing the record online.

(2) Set up a monitoring period for new raw materials. The "Regulations" does not leave the record management of ordinary new raw materials all alone. In addition to clearly stipulating the information requirements to be submitted when applying for the registration or filing of new cosmetic raw materials in Article 12, it also specifically stipulates in Article 14 , Within 3 years after the registered and filed new cosmetic raw materials are put into use, the registrant and filer of the new raw materials shall report the use and safety of the new raw materials to the drug regulatory department of the State Council every year. For new cosmetic raw materials that have safety problems, the drug regulatory department under the State Council shall deregister or cancel the record. New cosmetic raw materials that have not had any safety issues after the three-year period expires will be included in the list of used cosmetic raw materials formulated by the drug regulatory department of the State Council.

Ensuring the safety of use is the bottom line of the management of cosmetic raw materials (including new raw materials). The measure of setting up a monitoring period for new raw materials can be understood as implementing classification management of new cosmetic raw materials and simplifying the use procedures of common new raw materials. At the same time, new raw material registrants and recorders must pay close attention to the safety of their use after the new raw materials are on the market, and implement relevant regulations. The main responsibility of the enterprise is to ensure the safe use of new raw materials. In fact, to ensure the safe use of new raw materials is also to ensure the self-interest of related companies and promote their long-term development.

2. "Regulations" emphasize the safety of raw materials

Raw materials are the basis of cosmetics and the source of the entire life cycle of cosmetics. Generally speaking, cosmetics are a mixture of various raw materials processed and prepared in accordance with the formula ratio, and most of this preparation is a physical mixing process, with few chemical reactions involved. Therefore, the safety and function of raw materials directly affect the safety and performance of finished cosmetics.

(1) Emphasize the use of raw materials up to standards and compliance. The "Regulations" emphasizes that the raw materials used in the production of cosmetics should comply with mandatory national standards and technical specifications, and that expired, discarded, or recycled cosmetic raw materials must not be used. In the "Regulations" Chapter IV Supervision and Management, it is proposed that in accordance with the development of scientific research, when there is a change in the knowledge of the safety of cosmetics and its raw materials or problems are found, the relevant registrant and filing party may be ordered to conduct a safety reassessment. Really pay attention to the safety of raw materials and products with a developmental vision, thoroughly implement the concept of scientific supervision, and ensure the safety of cosmetics.

(2) Penalty clauses are specifically set for raw materials. The fifth chapter of the "Regulations" legal liability clarifies corresponding penalties for illegal situations such as the use of prohibited raw materials, unregistered or filed new raw materials, raw materials that do not meet national mandatory standards, technical specifications, and expired raw materials.

The "Regulations" pay more attention to the management of cosmetic raw materials, directly address the key and difficult points of cosmetics safety supervision, and have a very positive significance for effectively improving supervision efficiency, plugging supervision loopholes from the source, and ensuring the safety of cosmetics.

3. The "Regulations" clearly proposes to encourage innovation and meet industry development needs

(1) Classification management of new raw materials is conducive to innovation. According to the composition characteristics of cosmetics, in the current relatively mature preparation process, the innovation of cosmetics mainly depends on the innovation of raw materials, especially the development and innovation of functional raw materials and raw materials that contribute to the improvement of cosmetic formulations. Previously, in accordance with the requirements of the "Regulations on Hygiene Supervision of Cosmetics," my country implemented overall registration management for new cosmetic raw materials. Because there is no classification management, and the review criteria are not refined in conjunction with the characteristics of cosmetic raw materials, companies applying for a new raw material, even if it is only a high molecular polymer with no transdermal ability or edible ordinary vegetable oil, often need to be supplemented multiple times. According to the data, it takes several years on average to declare new raw materials, and only a handful of new cosmetic raw materials have been approved in China in the past 10 years. On the one hand, the enthusiasm of enterprises to declare new raw materials is affected. On the other hand, new raw materials that have been proven to have good performance and are widely used in the world cannot be used in Chinese cosmetics. This has also increased the number of Chinese cosmetics. The gap with foreign companies in terms of technology and innovation.

Cosmetics is a fashion industry, and the fast product update cycle is an outstanding feature of the industry. This feature of the industry requires companies to continuously introduce new products to the market. The classification management of new raw materials will undoubtedly play a very important role in improving the overall performance and quality of cosmetics.

(2) Encourage technological innovation at the same time. The "Regulations" encourages cosmetics companies to innovate not only in the management of new raw materials, but the "Regulations" clearly stated in the general provisions: "The state encourages and supports the development of cosmetics research and innovation to meet consumer needs. National protection units and The legitimate rights and interests of individuals to carry out cosmetic research and innovation."

A highlight of the "Regulations" is to encourage innovation, which is good for the healthy development of the entire industry. The development of a country is inseparable from science and technology, and the development of an industry, especially the cosmetics industry as a fashion industry, is inseparable from the overall emphasis on science and technology and the improvement of corporate innovation capabilities. An enterprise that does not have technical strength but only uses "story-writing" to attract consumers will not do it for long. Only innovation-driven development will have a better future.

The reason why the future is worth looking forward to must be her beauty. Let us not forget our original intention, and set off when the "Regulations" is promulgated, and jointly welcome the new future of the healthy development of my country's cosmetics industry!

About the author: Xu Liang, male, professor-level senior engineer. He is currently a member of the Cosmetic Standards Expert Committee of the State Food and Drug Administration, a cosmetic technology review expert, a distinguished professor of the Advanced Research Institute of the State Food and Drug Administration, and the chairman of the Cosmetic Expert Committee of the Beijing Municipal Food and Drug Administration. He graduated from Beijing Technology and Business University with a bachelor's degree in daily chemical industry. He has been engaged in the research of cosmetics and its raw materials for more than 30 years. Published more than 70 papers, participated in the compilation of many books such as "Cosmetics Safety and Management Regulations" and "Cosmetics Supervision Practices", and participated in China's "Regulations on the Acceptance of Cosmetic Administrative Licensing Application" and "Key Points of Cosmetic Technology Review" and other cosmetic regulations The drafting, revision and verification of the (Xu Liang, Beijing Institute of Daily Use Chemistry)

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