The Food and Drug Administration publishes technical guidelines for the research of listed Chinese medicine change
2021-07-05 03:03:27
The State Food and Drug Administration has recently issued the “Technical Guiding Principles for the Study of Changed Listed Chinese Medicines (I)†and pointed out that if quality standards have low controllability for drug quality and it is difficult to assess the impact of changes, quality and quality standards research work should be conducted. , Improve the quality standards for the controllability of drug quality.
It is reported that the guiding principles are mainly used to guide applicants to carry out changes in the production, quality control, and use of listed TCM preparations. The applicant shall carry out corresponding technical research work based on the impact of its changes on the safety, effectiveness and controllability of the drug. After completing the relevant work, the applicant shall submit a supplementary application to the drug regulatory department. A change request that requires a clinical trial study should have its clinical trial study performed after approval.
The guiding principles currently mainly cover the following items: change of drug specifications or packaging specifications, change of excipients in drug prescriptions that already have medicinal requirements, change of production process, change of drug expiration or storage conditions, change of packaging materials and containers of drugs, change of drug production sites Wait. For other changes, corresponding work should be carried out in accordance with the basic principles of this guiding principle according to their specific conditions.
The guiding principle divides the changes mentioned into three categories according to the degree of influence of changes on the basis of medicinal substances or absorption and use of drugs: Type I changes are minor changes, and changes do not cause changes in the basis of medicinal substances; Type II The change is a moderate change, and the change has an impact on the basis of the drug substance or the absorption and utilization of the drug, but the change is not significant; the class III change is a major change, and the change will cause a significant change in the drug substance basis, or the drug The absorption and utilization may have a significant impact. (Source: Legal Network reporter Hu Jianhui)
The specific contents of the "Technical Guiding Principles for Research on Change of Listed Chinese Medicines (I)" are listed below:
The State Food and Drug Administration issues and publishes the "Technical Guiding Principles for Research on Change of Listed Chinese Medicines (I)"
Posted on November 28, 2011
In order to scientifically regulate and guide the research work of listed Chinese medicine changes, and ensure the quality of research, the State Food and Drug Administration has organized the “Technical Guiding Principles for the Study of Changed Listed Chinese Medicines (I)†and issued them on a few days ago.
"Guiding Principles (1)" Basic principles and requirements for research on changes in listed Chinese medicines, changes in drug specifications or packaging specifications, changes in excipients in pharmaceutical prescriptions that already have medicinal requirements, changes in production processes, changes in drug expiration or storage conditions, and changes in drugs The packaging materials and containers were clearly defined.
It is reported that the guiding principles are mainly used to guide applicants to carry out changes in the production, quality control, and use of listed TCM preparations. The applicant shall carry out corresponding technical research work based on the impact of its changes on the safety, effectiveness and controllability of the drug. After completing the relevant work, the applicant shall submit a supplementary application to the drug regulatory department. A change request that requires a clinical trial study should have its clinical trial study performed after approval.
The guiding principles currently mainly cover the following items: change of drug specifications or packaging specifications, change of excipients in drug prescriptions that already have medicinal requirements, change of production process, change of drug expiration or storage conditions, change of packaging materials and containers of drugs, change of drug production sites Wait. For other changes, corresponding work should be carried out in accordance with the basic principles of this guiding principle according to their specific conditions.
The guiding principle divides the changes mentioned into three categories according to the degree of influence of changes on the basis of medicinal substances or absorption and use of drugs: Type I changes are minor changes, and changes do not cause changes in the basis of medicinal substances; Type II The change is a moderate change, and the change has an impact on the basis of the drug substance or the absorption and utilization of the drug, but the change is not significant; the class III change is a major change, and the change will cause a significant change in the drug substance basis, or the drug The absorption and utilization may have a significant impact. (Source: Legal Network reporter Hu Jianhui)
The specific contents of the "Technical Guiding Principles for Research on Change of Listed Chinese Medicines (I)" are listed below:
The State Food and Drug Administration issues and publishes the "Technical Guiding Principles for Research on Change of Listed Chinese Medicines (I)"
Posted on November 28, 2011
In order to scientifically regulate and guide the research work of listed Chinese medicine changes, and ensure the quality of research, the State Food and Drug Administration has organized the “Technical Guiding Principles for the Study of Changed Listed Chinese Medicines (I)†and issued them on a few days ago.
"Guiding Principles (1)" Basic principles and requirements for research on changes in listed Chinese medicines, changes in drug specifications or packaging specifications, changes in excipients in pharmaceutical prescriptions that already have medicinal requirements, changes in production processes, changes in drug expiration or storage conditions, and changes in drugs The packaging materials and containers were clearly defined.
In this category, you will find test tube and stand in many various sizes and variations. For laboratory work, Test tubes and Test tube racks is an essential element of all labs. Test tube racks allow the test tube to be securely held upright so that nothing can run out while filling the tubes.
Measuring cup is another one of the basic consumable container in lab. Except Test tube racks, Yingmed also supply other lab device holder like Stand base, Lab Jack, Pipette Stand and Laboratary Clamp in this category. If you can not find the one you need, please contact our customer services for more details.
Test Tube And Stand,Test Tube Rack,Test Tube Holder,Test Tube Stand
NINGBO YINGMED MEDICAL INSTRUMENTS CO.,LTD , https://www.chinayingmed.com