Many regulations and regulations in the pharmaceutical industry will be introduced densely this year
Release time: 2011-01-21 & nbsp & nbsp & nbsp Source:
Business Club, January 19th News The 2011 National Food and Drug Supervision Work Conference closed on January 14。Shao Mingli, Director of the National Food and Drug Administration, emphasized in the closing meeting summarizing the speech，It is necessary to unify the whole system's thoughts to the analysis and judgment of the situation in this meeting，We must focus the power of the whole system into the main task of the "Twelfth Five -Year Plan" development，It is necessary to implement the work of the full system until the key work arrangement in 2011。Member of the Party Group of the National Bureau、Deputy Director Wu Yan、Li Jiping、Bian My stake betting appZhenjia My stake betting appseparately deployed in charge of the work。
Member of the Party Group of the National Bureau、Li Donghai, the leader of the Discipline Inspection Team of the Central Commission for Discipline Inspection, conveyed the spirit of the Sixth Plenary Session of the 17th Central Discipline Inspection Commission at the summary meeting。Recent，The State Administration will hold a work conference on the construction of a clean and clean government，Specializing in the deployment of the relevant work of strengthening the construction of party style and clean government。
This year, there will be a number of food and drug regulatory regulations and systems.。This is the "Medical Economic Daily" reporter learned at the 2011 National Food and Drug Supervision Working Conference that Closed on January 14。
"Regulations on the Management of the Quality Management of Medical Devices" has been officially promulgated on January 1 this year，The new version of the drug GMP is also promulgated to implement。At the same time，Drug GSP is actively revised，"Regulations on the Management Regulations on the Registration of Medicinal Supplement Materials" is also being studied and formulated。Li Jiping, deputy director of the National Food and Drug Administration (SFDA), emphasized at the meeting，Administration in accordance with the law is the lifeline of the food and drug supervision system，Requirements that the whole system must be clear、Adhere to and promotes administration according to law without shaking。
It is understood，stake online sports bettingstake online sports bettingTo implement the implementation of the new version of GMP，SFDA will formulate a thorough implementation plan and related supporting documents，Improve inspection method and judgment standard，Highlighting dynamic inspection、Check it by variety，Emphasize software management，Urges enterprises to establish a strict production management system and a perfect quality guarantee system，Firmly establish the quality awareness of the whole process，Fundamental improvement of product quality guarantee。Current，Many pharmaceutical manufacturers are actively preparing for the new version of GMP。
At the same time，To promote the implementation of quality management responsibilities for production enterprises、Standards from the source，This year will formulate and promulgated the "Regulations on the Management Regulations on the Registration of Medicine and Auxiliary Materials"，It is required that manufacturers will conduct quality audit on the original auxiliary materials suppliers，and report to the provincial pharmaceutical regulatory departments for filing。The drug supervision department can supervise and inspect the filing information，Once problems are found，You can trace the roots，Tracking responsibility，Extension supervision。
In terms of equipment supervision，"Regulations on the Management of Quality Management of Medical Devices" has been officially promulgated and implemented，SFDA will be carefully organized and deployed stake betting appand implemented，Organize stake sports betting appthe guidance file for targeted organization。
December 2009，SFDA issued the "Medical Device Production Quality Management Specification (Trial)" and its supporting documents，and take the lead in the field of high -risk products in the fields of implanted medical devices and sterile medical devices.。From this，Medical Device Supervision began to grasp the quality from the source、The transformation from the final product to the entire process supervision。
Drug circulation，The revision of GSP is also actively being carried out。New requirements based on special rectification and promotion of medical reform，On the basis of extensive soliciting opinions，SFDA is accelerating the revised drug GSP，Improve technical requirements and entry thresholds，Guidance Drug business scale、Modernization Development，Standardize the order of drug circulation。
"Measures for the Report and Monitoring Management Measures" that has entered the final stage of the formulation，Soon will soon be introduced。This year SFDA will also study and formulate the "Measures for the Supervision and Management of Drug Research"，Focus on strengthening supervision of clinical research institutions，Standardize the clinical research behavior of drugs，Promote the improvement of the clinical research level of new drugs in my country，To better serve drug research and development innovation。
"Administrative Measures for Drug Standards" My stake betting appwill start research and stake sports betting appformulation，Clear Drug Standard Formulation、Amendment、Published、Implementation procedures。
In addition，SFDA will also accelerate the "Regulations on the Supervision and Management of Health Food"、The "Regulations on the Supervision and Administration of Medical Devices"，Do a good job of renovation and preparation of supporting rules and standardized documents of the above two regulations。(Wang Dan)
Member of the Party Group of the National Bureau、Li Donghai, the leader of the Discipline Inspection Team of the Central Commission for Discipline Inspection, conveyed the spirit of the Sixth Plenary Session of the 17th Central Discipline Inspection Commission at the summary meeting。Recent，The State Administration will hold a work conference on the construction of a clean and clean government，Specializing in the deployment of the relevant work of strengthening the construction of party style and clean government。
This year, there will be a number of food and drug regulatory regulations and systems.。This is the "Medical Economic Daily" reporter learned at the 2011 National Food and Drug Supervision Working Conference that Closed on January 14。
"Regulations on the Management of the Quality Management of Medical Devices" has been officially promulgated on January 1 this year，The new version of the drug GMP is also promulgated to implement。At the same time，Drug GSP is actively revised，"Regulations on the Management Regulations on the Registration of Medicinal Supplement Materials" is also being studied and formulated。Li Jiping, deputy director of the National Food and Drug Administration (SFDA), emphasized at the meeting，Administration in accordance with the law is the lifeline of the food and drug supervision system，Requirements that the whole system must be clear、Adhere to and promotes administration according to law without shaking。
It is understood，stake online sports bettingstake online sports bettingTo implement the implementation of the new version of GMP，SFDA will formulate a thorough implementation plan and related supporting documents，Improve inspection method and judgment standard，Highlighting dynamic inspection、Check it by variety，Emphasize software management，Urges enterprises to establish a strict production management system and a perfect quality guarantee system，Firmly establish the quality awareness of the whole process，Fundamental improvement of product quality guarantee。Current，Many pharmaceutical manufacturers are actively preparing for the new version of GMP。
At the same time，To promote the implementation of quality management responsibilities for production enterprises、Standards from the source，This year will formulate and promulgated the "Regulations on the Management Regulations on the Registration of Medicine and Auxiliary Materials"，It is required that manufacturers will conduct quality audit on the original auxiliary materials suppliers，and report to the provincial pharmaceutical regulatory departments for filing。The drug supervision department can supervise and inspect the filing information，Once problems are found，You can trace the roots，Tracking responsibility，Extension supervision。
In terms of equipment supervision，"Regulations on the Management of Quality Management of Medical Devices" has been officially promulgated and implemented，SFDA will be carefully organized and deployed stake betting appand implemented，Organize stake sports betting appthe guidance file for targeted organization。
December 2009，SFDA issued the "Medical Device Production Quality Management Specification (Trial)" and its supporting documents，and take the lead in the field of high -risk products in the fields of implanted medical devices and sterile medical devices.。From this，Medical Device Supervision began to grasp the quality from the source、The transformation from the final product to the entire process supervision。
Drug circulation，The revision of GSP is also actively being carried out。New requirements based on special rectification and promotion of medical reform，On the basis of extensive soliciting opinions，SFDA is accelerating the revised drug GSP，Improve technical requirements and entry thresholds，Guidance Drug business scale、Modernization Development，Standardize the order of drug circulation。
"Measures for the Report and Monitoring Management Measures" that has entered the final stage of the formulation，Soon will soon be introduced。This year SFDA will also study and formulate the "Measures for the Supervision and Management of Drug Research"，Focus on strengthening supervision of clinical research institutions，Standardize the clinical research behavior of drugs，Promote the improvement of the clinical research level of new drugs in my country，To better serve drug research and development innovation。
"Administrative Measures for Drug Standards" My stake betting appwill start research and stake sports betting appformulation，Clear Drug Standard Formulation、Amendment、Published、Implementation procedures。
In addition，SFDA will also accelerate the "Regulations on the Supervision and Management of Health Food"、The "Regulations on the Supervision and Administration of Medical Devices"，Do a good job of renovation and preparation of supporting rules and standardized documents of the above two regulations。(Wang Dan)
