State Drug Administration issued 7 technical guidance principles to standardize the safety re -evaluation of traditional Chinese medicine injection
Release time: 2010-10-22 & nbsp & nbsp & nbsp Source:
The website of the State Food and Drug Administration announced on the 21st that 7 technical principles such as the "Principles of the Safety Re -Evaluation of Traditional Chinese Medicine Injection Evaluation of Production Process Stake Sports Betting(Trial)stake online sports betting" announced on the 21st，Evaluation work with standards and guidance of the safety of traditional Chinese medicine injections。
These 7 technical principles include "Principles of the Safety Re -Evaluation of Chinese Medicine Injection Evaluation of Production Process (Trial)", "Principles of the Safety Re -Evaluation of Chinese Medicine Injection Evaluation Evaluation Evaluation," Clinical Research Evaluation Technical Principles (Trial) "" "Principles of the Safety Re -Evaluation of Chinese Medicine Injection Evaluations (Trial)", "Technical Principles of Enterprise Risk Control Capability of Chinese Medicine Injection Evaluation (Trial)"。
Where，"Technical Principles of the Safety Re -Evaluation of Chinese Medicine Injection Evaluation (Trial)" for the raw materials of Chinese medicine injections，Effective measures should be taken to ensure the stability of the quality of raw materials。At the same basis of fixed medicinal materials、Medicinal parts、Place of origin、Harvest period、Processing of origin、Storage conditions, etc.，Establish a relatively stable medicinal material base，Quality control of the entire process of medicinal materials，Use standardized planting medicinal materials as possible。with unmanned stake online sports bettingcultivation medicinal materials，Measures stake online sports bettingand methods of stable quality of wild medicinal materials should be clearly guaranteed。
Production process，Traditional Chinese medicine injections shall strictly follow the process parameters specified in the process rules、Craft details and related quality control requirements for production，and strengthen material balance and deviation management，Ensure that the quality of different batches of products is stable and uniform。
In addition，"Technical Principles of Enterprise Risk Control Capability Evaluation of Traditional Chinese Medicine Injection (Trial)" clearly pointed out，The risk management information provided by the enterprise should be enough to explain the specific situation of the relevant risk management work。Whether it can effectively control risks is the general principle of evaluating risk control capabilities。
According to the "Technical Principles of Enterprise Risk Control of Chinese Medicine Injection Risk Control (Trial)"，Evaluation of enterprises in terms of varieties of risk management includes active collection reports、Evaluation of stake betting appSuspicious Reporting ability，Evaluation of adverse reactions/event My stake betting appanalysis and evaluation ability，Group、Evaluation of emergency investigation and processing capabilities such as death adverse reactions/events，Evaluation of security research capabilities after launching，Evaluation of the ability to combing varieties and minimize risk。
Pay group、Evaluation requirements for emergency investigation and processing capabilities such as death adverse reactions/events，Enterprises should know the emergency incident and report the first time，At the same time, it should be temporarily controlled medicine、Investigation flow、Recall medicine、Test drugs、Investigation at the scene of the incident、Evaluation of the work ability of the event，It should also be different according to the degree of emergency events，Take different disposal measures。
These 7 technical principles include "Principles of the Safety Re -Evaluation of Chinese Medicine Injection Evaluation of Production Process (Trial)", "Principles of the Safety Re -Evaluation of Chinese Medicine Injection Evaluation Evaluation Evaluation," Clinical Research Evaluation Technical Principles (Trial) "" "Principles of the Safety Re -Evaluation of Chinese Medicine Injection Evaluations (Trial)", "Technical Principles of Enterprise Risk Control Capability of Chinese Medicine Injection Evaluation (Trial)"。
Where，"Technical Principles of the Safety Re -Evaluation of Chinese Medicine Injection Evaluation (Trial)" for the raw materials of Chinese medicine injections，Effective measures should be taken to ensure the stability of the quality of raw materials。At the same basis of fixed medicinal materials、Medicinal parts、Place of origin、Harvest period、Processing of origin、Storage conditions, etc.，Establish a relatively stable medicinal material base，Quality control of the entire process of medicinal materials，Use standardized planting medicinal materials as possible。with unmanned stake online sports bettingcultivation medicinal materials，Measures stake online sports bettingand methods of stable quality of wild medicinal materials should be clearly guaranteed。
Production process，Traditional Chinese medicine injections shall strictly follow the process parameters specified in the process rules、Craft details and related quality control requirements for production，and strengthen material balance and deviation management，Ensure that the quality of different batches of products is stable and uniform。
In addition，"Technical Principles of Enterprise Risk Control Capability Evaluation of Traditional Chinese Medicine Injection (Trial)" clearly pointed out，The risk management information provided by the enterprise should be enough to explain the specific situation of the relevant risk management work。Whether it can effectively control risks is the general principle of evaluating risk control capabilities。
According to the "Technical Principles of Enterprise Risk Control of Chinese Medicine Injection Risk Control (Trial)"，Evaluation of enterprises in terms of varieties of risk management includes active collection reports、Evaluation of stake betting appSuspicious Reporting ability，Evaluation of adverse reactions/event My stake betting appanalysis and evaluation ability，Group、Evaluation of emergency investigation and processing capabilities such as death adverse reactions/events，Evaluation of security research capabilities after launching，Evaluation of the ability to combing varieties and minimize risk。
Pay group、Evaluation requirements for emergency investigation and processing capabilities such as death adverse reactions/events，Enterprises should know the emergency incident and report the first time，At the same time, it should be temporarily controlled medicine、Investigation flow、Recall medicine、Test drugs、Investigation at the scene of the incident、Evaluation of the work ability of the event，It should also be different according to the degree of emergency events，Take different disposal measures。
