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Since May 28, the relevant state departments have announced the "Administrative Measures for Drug Inspection (Trial)" (hereinafter referred to as the "Measures"), which clearly requires that in order to further regulate drug inspection behavior and promote drug regulatory work to adapt to the new situation as soon as possible, all provinces The drug supervision and administration department shall, in accordance with the requirements of these "Measures" and in light of the actual situation of the administrative region, formulate implementation rules, refine work requirements, and organize inspections of drug production, operation and use.
After that, all parts of the country have begun to actively publish relevant policies.
.
Especially in the recent past, many provinces in China have successively issued plans for supervision and inspection of the drug market
.
For example, on November 8, the Shanxi Provincial Drug Administration issued the "Implementation Rules for Drug Inspection and Administration of Shanxi Province (Trial)" (Draft for Comment) (hereinafter referred to as "Rules") to regulate drug inspection behavior
.
The "Detailed Rules" apply to the inspection, investigation, evidence collection, and disposal of Shanxi Province's drug production, operation and use by the drug supervision and management departments at all levels in Shanxi Province, and the scope of implementation covers the entire retail pharmacy field
.
In addition, according to the "Detailed Rules" Shanxi Province has also given specific inspection frequencies for various drug dealers, such as compliance inspections for vaccine distribution companies not less than once a year, regional wholesale companies of narcotic drugs and first-class psychotropic drugs, and Compliance inspections of pharmaceutical precursor chemical raw materials wholesale companies are inspected no less than once every six months.
.
.
In addition to Shanxi Province, the Inner Mongolia Autonomous Region Drug Inspection Administration recently issued the "Implementation Rules for the Inner Mongolia Autonomous Region Drug Inspection Management Measures (Trial)" ( Hereinafter referred to as the "Detailed Rules"), the region's drug inspection work has also been regulated in terms of inspection agencies and personnel, licensing inspections, routine inspections, cause-related inspections, use and disposal of inspection results
.
It also clarified the departments (units) and personnel responsible for various inspection items
.
In addition, in October, the Fujian Provincial Drug Administration also officially issued the "Fujian Province Drugs Post-marketing Change Management Implementation Rules (Trial)" (hereinafter referred to as the "Implementation Rules")
.
The "Implementation Rules" includes five parts: general rules, registration management matters change filing procedures, drug production site change management, change filing supervision and management, and supplementary provisions.
It clarifies the application scope, handling procedures, and production site changes Processing path and other content
.
Generally speaking, drug safety is a project of people's livelihood and popular support
.
From the current point of view, the "Detailed Rules" issued by various regions are of positive significance to further standardize and guide drug changes after marketing
.
According to the current industry trends, the industry expects that in order to ensure drug safety, more and more provinces and cities will also issue relevant drug management regulations in the future, with stricter standards, stricter supervision, stricter penalties, and more serious questions.
Responsibility to do a good job in drug safety
.
In this context, for pharmaceutical companies, it is not only necessary to continuously strengthen attention to standardization and strengthen management in the production process, to ensure that the company is more efficient and safe in the daily production management process, but also to ensure compliance and development in the market, sales and circulation, etc.
.
After that, all parts of the country have begun to actively publish relevant policies.
.
Especially in the recent past, many provinces in China have successively issued plans for supervision and inspection of the drug market
.
For example, on November 8, the Shanxi Provincial Drug Administration issued the "Implementation Rules for Drug Inspection and Administration of Shanxi Province (Trial)" (Draft for Comment) (hereinafter referred to as "Rules") to regulate drug inspection behavior
.
The "Detailed Rules" apply to the inspection, investigation, evidence collection, and disposal of Shanxi Province's drug production, operation and use by the drug supervision and management departments at all levels in Shanxi Province, and the scope of implementation covers the entire retail pharmacy field
.
In addition, according to the "Detailed Rules" Shanxi Province has also given specific inspection frequencies for various drug dealers, such as compliance inspections for vaccine distribution companies not less than once a year, regional wholesale companies of narcotic drugs and first-class psychotropic drugs, and Compliance inspections of pharmaceutical precursor chemical raw materials wholesale companies are inspected no less than once every six months.
.
.
In addition to Shanxi Province, the Inner Mongolia Autonomous Region Drug Inspection Administration recently issued the "Implementation Rules for the Inner Mongolia Autonomous Region Drug Inspection Management Measures (Trial)" ( Hereinafter referred to as the "Detailed Rules"), the region's drug inspection work has also been regulated in terms of inspection agencies and personnel, licensing inspections, routine inspections, cause-related inspections, use and disposal of inspection results
.
It also clarified the departments (units) and personnel responsible for various inspection items
.
In addition, in October, the Fujian Provincial Drug Administration also officially issued the "Fujian Province Drugs Post-marketing Change Management Implementation Rules (Trial)" (hereinafter referred to as the "Implementation Rules")
.
The "Implementation Rules" includes five parts: general rules, registration management matters change filing procedures, drug production site change management, change filing supervision and management, and supplementary provisions.
It clarifies the application scope, handling procedures, and production site changes Processing path and other content
.
Generally speaking, drug safety is a project of people's livelihood and popular support
.
From the current point of view, the "Detailed Rules" issued by various regions are of positive significance to further standardize and guide drug changes after marketing
.
According to the current industry trends, the industry expects that in order to ensure drug safety, more and more provinces and cities will also issue relevant drug management regulations in the future, with stricter standards, stricter supervision, stricter penalties, and more serious questions.
Responsibility to do a good job in drug safety
.
In this context, for pharmaceutical companies, it is not only necessary to continuously strengthen attention to standardization and strengthen management in the production process, to ensure that the company is more efficient and safe in the daily production management process, but also to ensure compliance and development in the market, sales and circulation, etc.
.
