What expectation does food medical instrument have to supervise safely this year

What expectation does food medical instrument have to supervise safely this year
Staff reporter king Yang QiuLan kings of the people Yue is red At the national food pharmaceuticals administration working conference that is held on January 14, national food medicines supervise Liu Yi, Deputy Bureau Director of administration bureau, Zhang Jinli, Wu Zhen have analyzed on food, medical equipment, medicines safe and present situation and existing problem separately, and put forward the supervision action of 2009 to the question. Medicines Israel " Guarantee the safety " Supervise Wu Zhen, Deputy Bureau Director of administration bureau, saying for national food medicines in the centre, 2009, medicines want Israel while supervising " Guarantee the safety " It is the centre, direct against the weak link, strengthen the supervision measure, checking on before strengthening medicines and going on the market from source, from strengthening the supervision of listing medicines in the whole course, improve the medicines standard technically. Face the problem: In our country's current national medicines standard, a considerable amount of standard levels are not high, especially the variety of the national standard rises in the land mark, the question is more outstanding. Several medicines quality incident happening in recent years, and medicine supervises the department and organizes injectable preparation prescription and production technology that is launched to verify, exposing some medicines standards has defects, even potential safety hazard. Main measure: Since 2009, revise and improve 2000 medicines standards every year, promote the listing medicines standard in an all-round way in a planned way, step by step, realize over the next several years " The chemical medicines standard is in line with international standards " , " the traditional Chinese medicine standard is promoted, safer and controllabler " Goal; Make " standard management of medicines ", improve and regard " Chinese pharmacopoeia's " standard as the standard system of national medicines supplemented by core, medicines register the standard. Set up eliminating the mechanism, the too clinical to use again or variety that the new pharmacopoeia has already delete been inaccurate to curative effect of medicines standard, eliminate in accordance with the law. To the long-term variety not produced, possess the assortment of the working condition, have assortment of the serious potential safety hazard and variety of doing research not according to the regulation, will not register again. In 2009, should appraise traditional Chinese medicine injectable preparation again, will improve and improve its quality criteria, the range rationally of the safe risk control. Verify have defect, the intersection of bad reaction and case report more to prescription and production technology, the intersection of selling price and unusually low, the intersection of masses and enterprise and variety concentrated on to report want, strengthen, inspect by random samples. Face the problem: The medicines production and management of our country " A lot of, small, break up, low " ,The industrial structure is unreasonable to strengthen the safe risk of medicines. Main measure: In 2009, should improve the entry threshold, examine and approve and check on strictly, encourage and support innovation, reduce low-levelly and repeat; Encourage realizing the same trade annexes, selects the superior and eliminates the inferior, promote industry's integral level. Revise the standardard management of quality of production of medicines (GMP) ,It strengthen it have about manufacturing enterprise because following check and have because of efforts which flight check. Face the problem: Medicines bad reaction (ADR) at present The level of monitoring and report is also not high, the proportion of the serious ADR report is not high, enterprises have not collected and appeared in the newspaper the consciousness of ADR voluntarily. Main measure: In 2009, should strengthen the bad reaction monitoring of medicines, will make sure to find quickly, report quickly, investigate quickly, deal with quickly, announce quickly; Strengthen the medicines bad reaction and monitor organizational construction; Improve the bad reaction monitoring of the medical organization; Lead enterprises to collect and report the medicines bad reaction voluntarily. The strict market access of food strengthens and supervises national food medicines and supervises Liu Yi, Deputy Bureau Director of administration bureau, saying at ordinary times, 2009, link food security of consumption, health food and cosmetics supervise strict market access, strengthen, supervise, strengthen the safety of safe prewarning system and food construction of emergency ability at ordinary times. Face the problem: Units of food and beverage are in large quantity, in small scale, the foundation is bad, the objective reality of the disparate development remains as before. Main measure: 2009, want, take catering trade and school dining room as the focal point, organize implementation of the food hygiene, quantize differentiated control and assess and then further in the whole country; Choose dining room and the construction site dining room, rural unlicensed business activity of the school to carry on the special renovation pointedly. Serve the meals collectively and school and the intersection of construction site and dining room, home-delivery center, countryside prepare a feast etc. to regard as the key supervised target by oneself, regard food processing, washing sterilizing and the temperature and control of time,etc. that store, transport in the course as key supervision links. Face the problem: In the market of health food, produce and manage health food, violation add the intersection of medicine and composition, false illegally and exaggerate propagate illegally and ordinary food propagate the intersection of health care and function, exist still without licences. Cosmetics raw materials use the norm incompletely, add and forbid medicines, exaggerates falsely and propagates to mislead the behavior of public consumption to remain incessant after repeated prohibition in violation of rules and regulations. Main measure: Discuss and make the cosmetics and annotate the standardard management of labels and hygiene of manufacturing enterprise and permit management, discuss and make health food, cosmetics production and management and supervise the guideline, revise " hygiene norm of manufacturing enterprise of the cosmetics ", increase the requirement for the respect of managing for cosmetics raw materials specification, professional apparatus and reporting, sale of operation, bad reaction information gathering etc.; While exploring the management idea of endangering chemistry incorporates the production process to the cosmetics and supervises. Launch the whole country and renovate non- medicines and pretend to be the special action of medicines, classify and renovate " The food, sterilizing products, health food, cosmetics, health product, not having code products " 6 kinds of non- medicines products, attack the illegal activities that non- medicines pass off as medicines sternly. The medical equipment builds and supervises Zhang Jinli, Deputy Bureau Director of administration bureau, talking for food medicines of key country with regulation system and standard, in 2009, the medical equipment will supervise and regard improving regulation system and standard to build as the focal point, advance technological surveillance and technology of the medical equipment to examine and comment the construction of system thoroughly, tamp the supervision foundation, the intensification is supervised safely. Face the problem: By the end of 2008, there are 13141 manufacturing enterprises of medical equipment in all in the whole country. On the whole, it is unreasonable to produce the operating structure, the question with unstandard order is still outstanding. Main measure: In 2009, will start planting into risky medical equipment code and information-based pilot work partly, explore the whole monitor method of the trends. Issue " standardard management of quality of production of the medical equipment " as soon as possible, strengthen the supervision and management which is designed the overall quality system of developing, producing, installing, selling and serving etc.. Discuss and make " test and buy the product management of medical equipment and confirm the standard ", the order of standardizing the medical equipment and managing the market. Strengthen the bad incident of the medical equipment to monitor and appraise the work again. Face the problem: At present, our country has 169 national standards of medical equipment in all, 585 sector standards, but the standard system is incomplete, the standard mechanism of management is not smooth, the organization is imperfect, management is unstandard, standard such problems as the quantity is insufficient remain as before. Main measure: Set-up The standardized committee of national medical equipment, the ones that solved and formed because of system problem at present, to professional each department acting on its own of Technical Committee, situation that management does one's best; Strengthen the base correctly? ��'s bath It is at a disturbance of Bodhisattvas to ull up that the persons who narrow Yao is jealous Decayed tooth �� worried to fall from the sky or outer space while being fervent �� the intersection of �� and Lue herd chivalrous chirp stir broken the intersection of Yan and ins and outs Hu �� Yao in great numbers is jealous to receive Peng Luo =The arm spread iron chains were fresh to invite dysentery that �� fled in small jar Shang Ren Pu step on the intersection of Jia and Qiang, swallow, flee the intersection of shelf and �� fly to the intersection of uncut jade and Fu? 6 kinds of products and 93 standard ones make revision. Face the problem: Medical equipment technological the intersection of surveillance and construction start late based on a weak economy, total arrangement and developing direction of check organization need further clarifying, measuring ability needs further improving. Main measure: Improve the total arrangement of check organization of medical equipment; Through macro adjustments and controls and state finance project support, plug a gap and examine the project, promote and measure ability. At present, apply until Beijing, Shanghai 9 national-level medical equipment expanded to upgrade offer yuan of treasury bond financial support with apparatus in laboratory of monitoring center already, apply for the apparatus of monitoring center of 23 pieces of provincial medical equipment and allocate the funds of nearly 250 million yuan, still apply for the local related fund of nearly 300 million yuan. Face the problem: The registered work of the medical equipment technology exists and examines and comments strength weakly yet at present, question of examine and comment, examine and approve yardstick and does not unify ing etc.. Main measure: Do a good job of " whether medical equipment register technology check guideline " write, work, try, release, examine the guideline to 10 technology by 6 again, examine and comment the guidance of examination and approval to the first kind, class II variety in order to strengthen; Make " standardard management of the quality of clinical trial "; Research and supervision of special variety of norm, set up medical instrument and make the products up and examine and comment and examine and approve the mechanism; Accelerate advancing the medical equipment to classify and name the work. Set up and employ the database, it is thinning and supplementing and improving " classified catalogue of medical equipment ", set about discussing and making " naming rule of the medical equipment ".

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