Chinese medicine tablets do not meet the drug standards belong to the "not affected by safety, effectiveness"

On September 8, the Anhui Provincial Drug Administration issued a notice on soliciting opinions on "the guidance (draft for comments) on the non-compliance of Chinese medicine tablets with drug standards and does not affect the determination of safety and effectiveness".
notice of the new drug management law, the Chinese medicine tablets "special punishment" provisions "does not affect the safety, effectiveness" has been defined.
I. The scope of "Chinese medicine tablets that do not meet the drug standards and do not affect safety and effectiveness" as mentioned in this Opinion refers to "other drugs that do not meet the drug standards" as stipulated in Article 98, paragraph 3, paragraph 7, of the Drug Administration Law of the People's Republic of China, excluding items 1 to 6.
II, "other drugs that do not meet the drug standards", excluding toxic herbs, traits are limited to the shape, size, surface color three aspects, inspection items are limited to water, ash, debris impurities three aspects.
Article 117 Of the New Drug Administration Law, the production or sale of inferior drugs shall confiscate the drugs and illegal proceeds illegally produced or sold, and shall be punished with a fine of 10 times or less than 20 times the value of the drugs illegally produced or sold; If the amount is less than 100,000 yuan, the value of the illegally retailed drugs shall be less than 10,000 yuan, and if the circumstances are serious, the company shall be ordered to stop production and rectify the drug approval documents, the drug production license, the drug business license or the medical institution's preparation license.
chinese medicine tablets produced and sold do not meet the drug standards and do not affect safety and effectiveness, they shall be ordered to make corrections within a specified period of time and given a warning;
July 28, the Fujian Provincial Drug Administration released a public table of information on administrative penalties, which deserves the attention of people in the Chinese medicine industry.
(see the implementation of the new drug administration law, fined more than 1.1 million!) Fujian Tianrui Pharmaceutical Co., Ltd. sales of melon(manufacturer: Anhui Yijiantang Chinese medicine tablets Technology Co., Ltd.; dosage form: Chinese medicine drink tablets; packaging specifications: 0.5 kg / package; batch number: 180101), by Quanzhou City Food and Drug Inspection Institute, "the nature" does not meet the "Chinese Pharmacopoeia (2015 edition)" a provision, the test conclusion is not in accordance with the provisions.
11 times (less than 100,000, according to 100,000) and 1.1 million under the new Drug Administration Act.
the nature is not qualified, the reason is the use of immature melon fruit processing, does not apply to the new drug management law, Article 117, paragraph 2 of the "exemption" clause: "the production and sale of Chinese medicine tablets do not meet the drug standards, does not affect the safety and effectiveness, ordered to correct within a time limit, give a warning;
" Chinese medicine tablets are not qualified for many reasons, which belong to the "not yet affect the safety, effectiveness", the urgent need for norms, Anhui Bureau issued this "guidance" is very timely.
The following is the original text: In order to implement General Secretary Xi Jinping's "four most stringent" requirements on drug safety, safeguard the legitimate rights and interests of enterprises in accordance with the law, strictly regulate law enforcement, in accordance with the Administrative Punishment Law of the People's Republic of China, the Drug Administration Law of the People's Republic of China and other relevant laws and regulations and standards, our Bureau has drafted "Chinese medicine tablets do not meet drug standards, does not affect the safety, effectiveness of the guidance (draft for comments)," is now open for comments.
comments and suggestions, please return them to our Bureau in writing or by e-mail by September 16, 2020.
Contact: 0551-62999232; ZIP Code: 230051; Address: Area B 12-14F, 509 Maanshan Road, Hefei City; E-mail: zcfgc2017@126.com.
Guidance on the determination that "Chinese medicine tablets do not meet drug standards and do not affect safety and effectiveness" (draft for comments) In order to implement General Secretary Xi Jinping's "four most stringent" requirements on drug safety, safeguard the legitimate rights and interests of enterprises in accordance with the law, strictly regulate law enforcement, and in accordance with the provisions and standards of relevant laws and regulations such as the Administrative Penalty Law of the People's Republic of China and the Drug Administration Law of the People's Republic of China, Does not meet the drug standards, does not affect the safety and effectiveness of the application, put forward the following guidance: First, the scope of "Chinese medicine tablets do not meet the drug standards, does not affect the safety and effectiveness" refers to the "other drugs that do not meet the drug standards" stipulated in Article 98, paragraph 3, paragraph 7, of the Drug Administration Law of the People's Republic of China, excluding items 1 to 6.
II, "other drugs that do not meet the drug standards", excluding toxic herbs, traits are limited to the shape, size, surface color three aspects, inspection items are limited to water, ash, debris impurities three aspects.
As follows: 1. Shape: No significant difference between the visual appearance shape and the standard shape, or no significant difference after soft observation; 2. Size: drinks that need to be sliced, 5-10mm in length, no more than 10% of the standard value; 10-15mm, no more than 20% of the standard value, 1-2mm thick and thin, no more than 10% of the standard value, 2-4mm thick and thin, no more than 20% of the standard value, drinks that need to be sliced, The diameter standard is 2-3mm, not more than 10% of the standard value, the diameter standard is 5-10mm, not more than 20% of the standard value, the drink tablets that need to be cut are 8-12mm squares, not more than 20% of the standard value, 3. Surface color: No significant difference was observed with the naked eye; 4. Moisture: moisture standard below 13% (including 13%), not more than 10% of standard value, moisture standard above 13%, no more than 20% of standard value, 5. Ash: gray standard at 2% between -5%, not more than 10% of the standard value, more than 5% of the gray standard, not more than 20% of the standard value, 6. Pyrethr impurities: the standard of pharmaceutical crumb impurities within 3%, the actual content of confetti impurities does not exceed 5%.
3. Before applying Article 117, paragraph 2, of the Drug Administration Law of the People's Republic of China to make a decision on administrative punishment, the case handling department of the provincial bureau shall organize the relevant experts to make written judgments and explain the reasons in the light of the Report on the Non-conformity of Chinese Medicine Tablets and the relevant drug standards.
Fourth, chinese medicine tablets produced and sold by Chinese medicine tablets production enterprises do not meet the drug standards, does not affect the safety and effectiveness, and there is evidence that the violation of the law is minor and timely correction, did not cause harmful consequences, whether to pay a fine penalty, the case handling agency in accordance with the Administrative Penalty Law of the People's Republic of China, Article 27, paragraph 2, combined with the case, comprehensive investigation and judgment.
, Anhui Province, September 2020