Administration of medical network on February 27 - publish important information: in 2017, to check 138 varieties of clinical usage and high risk!
On February 24, the national drug sampling work conference held in chengdu, the state food and drug administration and party member and deputy director of the wu to attend the meeting and delivered a speech.
Wu stressed that in 2017, the drug sampling to six things:
Arrange one: 2017 of 138 varieties of clinical usage and high risk for quality checking and exploratory research;
Second: the formation of national sampling plan, sampling plan, sampling observation of cities provinces work a chess game, improve the efficiency of sampling;
Third: the sampling substandard medicines, risk control products in time, the first time according to the risk and take off the shelves, storage and recall measures.
Administration of its 4: weekly issue of drug sampling information announcement, and the drug sampling information around the unified management, grasping the sampling information posted by the provincial bureau, in administration of synchronous release site, around the unqualified drug information into a unified database, available to the public for inquiry, accept the supervision of the masses.
Five: to always check out the unqualified drugs in tracking sampling, related businesses included in the track inspection, always sampling found serious quality risks and issues, as the inspection object, to ensure the rectification in place.
Its six: strengthen inspection personnel team construction, improve the innovative ability of test method.
▍ 138 clinical varieties are those?
Drugs sampling density increasing, unqualified drugs from the shelves and recall every week to send notification and tracking check drug firms, administration of deployment of drug sampling 2017, impenetrable and unprecedented. Six sides, forming a net, once the drug quality problems, immediately surfaced, well known.
Published in it, wu, director of clinical usage and high risk "of 138 varieties of sampling observation of quality" for human. So, what is 138 specific varieties? Have your own? I'm afraid these questions most industry attention.
May be due to raid, administration was given in the notification list, but has been administration "point," medicines, in theory, more likely to be the key spot check.
So, the administration of blue parker will be sampling announcement varieties since 2016 to arrange, to remind the related drug firms, perhaps these varieties in 138; If not, also cannot treat STH lightly, after all, in 2017 for sampling and for all the drug companies.
▍ these varieties are the key to check the risk is bigger
Attached: strengthen the risk prevention and control, adhere to the problem leads to build a new pattern of "big sampling"
On February 24, the national drug sampling work conference held in chengdu, the study and implement the national food and drug supervision and administration work conference spirit, comprehensive summarize 2016 drug sampling inspection work, the deployment of 2017 drug sampling key tasks. The state food and drug administration and party member and deputy director of the wu to attend the meeting and delivered a speech.
Conference pointed out that over the past year, the whole system in strict accordance with the "four most strict requirements," the creative thinking to reform steadily promoting drug sampling work, in checking pertinence, timeliness, information openness problem disposal normative has obviously improved, and the linkage of the inspection and monitoring work obviously enhanced, play an important role in the drug administration.
It is around the regulatory focus, strengthen sampling inspection, expand coverage for sampling, continue to maintain a complete coverage of essential medicines varieties checking.
The second is to carry out the problem oriented, found to further improve the ability of the risk and problem. In 2016 the national drug sampling conducted research, such as "price cost down breed" through the exploratory study, found some companies do STH without authorization changes process illegal production, quality management system has defects such as material quality risk and problems.
3 it is inspection check linkage, sampling inspection results to the efficient conversion of supervision results. According to the problems found during the inspection, administration organization or deployment ShengJu flight check. In an illegal drug prevention and control of production rules, played an important role in the quality risk.
Four is service in regulation, the enterprise to carry out the principal responsibility initiative to increase. In 2016, the administration sent 471 production enterprises, 586 "drug quality prompt letter", to guide enterprises trying to identify the quality risk, eliminate hidden dangers, continuously improve product quality.
5 it is constantly promoting informatization construction, sampling process management level of ascension. Through "national drug sampling information system", implements the drug sampling from sampling to verify the disposal of the whole process of network management, can real-time submitted online. "National drug sampling data platform" and "national drug sampling information query the database to achieve reunification of the big drug sampling data collection and management and convenient inquiry and supervision from all walks of life.
Wu stressed that in 2017, to a solid drug sampling work from six aspects:
To elaborate organization, national drug sampling task. Arranged in 2017 of 138 varieties of clinical usage and high risk for quality checking and exploratory research. In the sampling process, increase the management and use directly to consumers at the end of the sampling proportion, the inspection, the exploratory research, major issues submitted, verification treatment of new specific requirements are also put forward.
Second, we must integrate sampling resources, make overall drug sampling. National sampling plan, provincial sampling plan, sampling observation of cities work a chess game, improve the sampling efficiency.
Third, we need to hunt down heavy, completes the unqualified drug treatment and investigation. For sampling substandard medicines, risk control products in time, the first time according to the risk and take off the shelves, storage and recall measures.
Fourth, we need to promote social work, to do a good job of sampling information release. Administration of weekly issue of drug sampling information announcement, and the drug sampling information around the unified management, grasping the sampling information posted by the provincial bureau, in administration of synchronous release site, around the unqualified drug information into a unified database, available to the public for inquiry, accept the supervision of the masses.
Five to encourage innovation, the management of drug sampling. To innovate checking train of thought, to further increase the linkage of the inspection work, and explore the inspector on the working mechanism of sampling to always found problems in the sampling inspection, to the rectification of the enterprise to carry out the situation to carry out the "look back", to always check out the unqualified drugs in tracking sampling, related businesses included in the track inspection, always sampling found serious quality risks and issues, as the inspection object, to ensure the rectification in place.
Six to continuously enhance the level of inspection and found the problem ability. Explore the achievements of inspection method, inspection results into regulatory means. Strengthen inspection personnel team construction, improve the innovative ability of test method. Inspection institutions should further perfect its own quality management system, to ensure the integrity of survey data, reliable, and traceable.
The provinces, autonomous regions and municipalities directly under the relevant person in charge of the food and drug administration, undertake the task of national drug sampling, head of the pharmaceutical inspection institutions, administration, head of the relevant departments and directly affiliated institutions. |
