"Measures for the Supervision and Management Measures for the Multiple Supervision and Management of Cosmetics Production and Management of Cosmetics and Medical Devices of Ningxia Hui Autonomous Region" policy interpretation

1. Revised the background

In 2019, our bureau formulated and issued the "Measures for the Method of Supervision and Management of the Risk Horgeous Supervision and Management of Cosmetics and Management and Management of Medical Devices in Ningxia Hui Autonomous Region (Trial). It played an important role. Since 2019, the "Drug Administration Law of the People's Republic of China" and "Regulations on the Supervision and Administration of Medical Devices" have been revised one after another. The "Regulations on the Supervision and Administration of Cosmetics" on June 16, 2020. On January 1, 2020, Ningxia Drug Smart Supervision Platform was launched and operated online. In order to connect with the current laws and regulations, at the same time better meet the needs of the current drug safety supervision, and combine the actual conditions of the drug supervision of our district, amending it on the basis of the "Measures" and extensively solicited from various aspects, and revised it Essence

2. Revision basis

1. "Pharmaceutical Management Law of the People's Republic of China"

2. "The People's Republic of China Vaccine Management Law"

3. "Regulations on the Supervision and Administration of Medical Devices"

4. "Cosmetics Supervision and Administration Regulations"

Third, the main content of revision

According to the abolition of laws and regulations and the actual situation of the drug supervision of our district, Article 1, 9, 10, 11, Article 16, and Article 17 of the Measures "Measures" And Annex 1 "Static Risk Speed ​​Form" was modified. The main modification content is as follows:

1. In accordance with the situation of abolition of laws and regulations, amended the "Regulations on the" Cosmetics Sanitation Supervision "" to the "Cosmetics Supervision and Management Regulations" in accordance with the "Cosmetics Health Supervision Regulations"

2. According to the type 9 of the administrative penalties of the "Administrative Penalty Law of the People's Republic of China" in 2021, Article 9 of the Measures "violates the laws and regulations of cosmetics of cosmetics and medical device cosmetics and regulations of the" Measures ", which is revised to warn administrative punishment to "Cosmetic safety laws and regulations violated drugs and medical device cosmetics, and they were warned and reported to criticize administrative penalties." "Modified to" violate drugs and medical devices of cosmetics safety laws and regulations, subject to administrative penalties such as temporarily detained permits, reducing qualification levels, revoking licenses, restricting production and operation activities, ordering production and suspension of business, ordering closure, and restricting employment. "

3. In accordance with the relevant provisions of the "Regulations on the Supervision and Administration of the People's Republic of China", "Regulations on the Supervision and Administration of Medical Devices", and "Regulations on the Supervision and Administration of Cosmetics", combined with the actual situation of supervision and inspection, the first paragraph 1 "found in the inspection process to find more than 3 production during the inspection process. The general items of business quality management do not meet the requirements and cannot be rectified according to the time limit. "The modification was modified to" find that there are 10 general defects within 10 general defects during the inspection ". Article 10 Paragraph 1 "The main defects of production and operation quality management specifications during the inspection process are found during the inspection process and cannot be rectified in time" to "found more than 10 general defects and main defects during the inspection process" during the inspection process. ; The second, "The production and sales of inferior drugs, medical devices that do not meet technical requirements, fake and inferior cosmetics" are modified to "produce and sell inferior drugs, unpaid first medical devices, ordinary cosmetics that have not been recorded"; third "If the quality accident of cosmetics in the cosmetics of major pharmaceuticals and medical devices has not been treated and reported in time", it is modified to "have not been treated and reported in time in time."

4. In accordance with the relevant provisions of the "Regulations on the Supervision and Administration of the People's Republic of China", "Regulations on the Supervision and Administration of Medical Device", and the Regulations on the Supervision and Administration of Cosmetics, amend the "production and sales of fake drugs" to "production and sales of fakes" The second category of medicine, the second category of medical device registration certificates, the third category of medical devices, and the special cosmetics that have not been registered "; the fourth item" provides false certification materials in the process of administrative approval and certification or adopts other deception, bribery, etc. The modification of the unfair means obtained the license or the approval document "is modified to" provides false certificates, data, data, samples, or other deception methods during the process of administrative approval and certification. Refusing, obstructing law enforcement officers of the drug supervision and management department to conduct supervision and inspection, drawing, and requesting relevant information in accordance with the law, or refusing to cooperate with law enforcement officers to conduct case investigations in accordance with the law, "revised to" refuse, evade the drug supervision and management department law enforcement officers to conduct supervision and inspection, draw test, and draw inspection, and Seek relevant information or refuse to cooperate with law enforcement officers to conduct case investigations in accordance with the law. "

5. According to the operation of the Ningxia Drug Smart Supervision Platform and the configuration of the system module, Article 14 "If the risk score changes, the regulatory authorities shall be a risk within 10 working days after determining the risk score change. If the score is adjusted to meet the conditions of risk level adjustment, the risk level is adjusted "to be modified to" changes in risk scores, and the regulatory authorities should pass Ningxia Drugs within 15 working days after determining the change in risk scores. The smart supervision platform adjusts the risk score to meet the conditions of risk level adjustment, and adjust the risk level. " The operator risk level evaluation form (see Annex 2), establish and gradually improve the corporate risk file to achieve one enterprise and one file. "The" Drug Supervision and Administration Department should make a quantitative evaluation in accordance with these Measures, relying on Ningxia Drug Smart Supervision The platform risk hierarchical module is established and gradually improved the corporate risk file. 6. According to the actual situation of the drug regulatory authorities at all levels, Article 16, paragraph 2 "December 2nd, the drug supervision and management department determines the cosmetic production and operators of the drug medical device according to these Measures. Annual risk level. "Modified to" December of each year, the drug supervision and management department determines the annual risk level of the cosmetics production and operator of the drug medical device according to these measures. "Article 17" can increase supervision and sampling batches, supervision and inspection frequency, etc. to increase supervision. "Modified to" improve or increase the batch of supervision and inspection and the frequency of supervision and inspection to improve the effectiveness of supervision. "

7. In accordance with the "Cosmetics Supervision and Administration Regulations", Annex 1 "Static Risk Risk Score Form for Cosmetics Production Enterprises in Ningxia Hui Autonomous Region" was modified "Production Products Contains Special Uses Cosmetic Enterprises" Skin care cosmetics, children's skin care cosmetics, toothpaste). "; Acne cosmetics and special groups, and special parts of the use of cosmetics "are modified to" only produce ordinary cosmetics, and do not produce acne cosmetics, enterprises that use cosmetics for special parts, and special parts. " The two items of the "Static Risk Risk Score Form for Cosmetics Management Enterprises in Ningxia Hui Autonomous Region" were merged into one "cosmetics business enterprise", and the static risk score was not adjusted.

After the revised "Ningxia Hui Autonomous Region Drug Medical Device Cosmetic Production and Management Risk Horbing Supervision and Management Measures", there are 18 articles, including formulation, basis, static score determination, dynamic score determination, score adjustment rating, and results.

The first to fourth is the purpose and basis for formulating the measures, the definition of risk grading management, and the scope of application and responsibilities.

Article 5 to 8 of the composition of risk scores and how to divide the risk level, clarify the determination method of static risk scores and dynamic risk scores.

Article 9 to 12 of what behavior of how much risk scores are given in accordance with the severity of the circumstances, and the same violations of the same violation of laws and regulations meet the two or more situations. Essence

Article 13 It stipulates different measures that can take different risk -level drug regulatory departments.

Article 14 to 17 stipulates that the scores of the pharmaceutical regulatory department, the responsibility, the evaluation of quantitative evaluation, and the combination of reasonable regulatory measures are used.

Article 18 stipulates the time limit of implementation.

The attachment is the static risk score table of the cosmetics of the pharmaceutical medical device, which can determine the static risk of the production and operation enterprise and the use unit of the cosmetics and use of the drug medical device according to this table.

Source: Ningxia Drug Administration

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