The Chinese vaccine supervisory system passes WHO assessment Will supply the international market

The Chinese vaccine supervisory system passes WHO assessment Will supply the international market
Chinese vaccine is opened to the host of gate of the world: Good evening, welcome to watch Economy 30 Minutes. We pay close attention to vaccine today. On March 1, 2011, World Health Organization announces in Beijing, the Chinese vaccine supervisory system passed its assessment. This means, the vaccine quality that China produces is reliable, its security and validity have been approved by international standard; China is domestic vaccine is qualified to apply for the pre- authentication of WHO, enter vaccine of the United Nations and purchase the plan, supply the international market. China may become one of the main supply countries of vaccine of par in the world during the following one two years. Bell adds more than the supervisory system of vaccine of doctor's World Health Organization: World Health Organization announces cheerfully, Chinese vaccine enterprises, from today, can apply to authorize to World Health Organization in advance on the vaccine that oneself produces. On March 1, 2011, World Health Organization announces, China authorizes through the national vaccine supervisory system formally. Assess as the supervisory system of this vaccine and the group leader of leading group of management system of quality, Wu Zhen is very excited so far. Wu Zhen's national food medicines supervise Wu Zhen, Deputy Bureau Director of administration bureau: This is that this is a very good news for supervision of our medicines to us, doubly encouraged. Wu Zhen, national food medicines supervise the Deputy Bureau Director of administration bureau, is engaged in the supervision of medicines for more than 30 years, he tells reporters, mean vaccine of China has supervised and already reached the world level through the assessment of World Health Organization, vaccine of China has obtained the chance that World Health Organization purchases at this point too. Yin Wei the Northeast Beijing department revitalizes general manager of Co., Ltd. Yin WeiDong of the biologicals: Go abroad, realize our Chinese vaccine serves world children. There is a more important meaning at the same time, our Chinese child can use vaccine the same as international standard, there are important meanings too. The evaluation system is approved by world, enterprises can move towards world, it is undoubtedly exciting to expand this on the market, but since March 1 through assessing to now, the reporter knows, only the few enterprises of part set about applying to authorize to World Health Organization in advance. Wu Zhen: Can only say that only some enterprises begin to be starting now, more possibility is after this, everybody knows progressively, apply for vaccine of World Health Organization and authorize the work. Reporter: Then till now, there is about one month, how many enterprises have already begun to apply for the pre- authentication of World Health Organization? Wu Zhen: This proportion is not big at present. Reporter: We hear such a statement, talk about the control evaluation system actually through WHO, one seem very much American thing actually, its symbolic meaning is greater than the actual meaning, how do you think about this kind of statement? Wu Zhen: At the request of World Health Organization, vaccine of a country should realize World Health Organization purchase in world, must evaluate supervisory system of this national vaccine, should talk so, the intersection of we and the intersection of vaccine and manufacturing enterprise, want, finish the intersection of World Health Organization and authentication of vaccine in an all-round way, this job will go if this job there should be a section of way, how long this road is, depend on the detailed conditions of each enterprise of ours. Wu Zhen tells reporters, not merely just showing the country will accord with the international standard to the supervision of vaccine through assessing, also put forward higher requirement for vaccine enterprises, mean higher product quality, need enterprises to continue increasing input, improve the level of production constantly, way in front is very long. Yin Wei the Northeast Beijing department revitalizes general manager of Co., Ltd. Yin WeiDong of the biologicals: We general budgetary estimate, grow the intersection of group and enterprise all these in the we, if all pass, it takes a few dozen and hundred million for the mere hardware to put, this is fund input; The second is time; Third I am regarded as the most difficult one, it is a change of a idea, the change of this idea, I think it is the most important too, it is the most difficult too. Host: The fact proves vaccine inoculation is considered to prevent the most effective method of infective disease. But vaccine is a double-edged sword, by the look of principle, vaccine is the deactivation in fact or reduces the toxic virus. Once vaccine quality does not pass, large-scale healthy people catch disease and even die. Then how to guarantee vaccine safety of our country? All the time, vaccine has inoculated widely and beneath mention, any news related to it will cause the enormous great waves. December 3 of 2009, national Bureau of Drugs Supervision releases the announcement and claims, Limited Company of the bio-pharmaceuticals and Jiangsu prolong and explain 7 batches that the Limited Company of biotechnology produced from July of 2008 to October in the good fortune of Hebei, altogether the persons of 215,800 have problems with the vaccine quality of rabies. Among March of 2010, Shanxi vaccine incident will happen, several dozen children are injured. At one time, compatriots strike torror at the topic of and vaccine. Then this national vaccine supervises the passing smoothly of evaluation system, whether mean vaccine of China is safe absolutely? Reporter: To the public, perhaps we care even more it is results and its security of vaccine, then can pass to control evaluation system smoothly this time, whether can benefit Volkswagen common people of China? Wu Zhen's national food medicines supervise Wu Zhen, Deputy Bureau Director of administration bureau: Should certainly all right, Chinese vaccine it assesses this to be whether one World Health Organization adopt one way generally in the whole world, presume the supervision and management of the whole vaccine as seven major plates, this seven major plates include, the vaccine supervision system of the country, including the permission before vaccine is listed, supervision after vaccine is listed, criticize the system issued, the monitoring of the vaccine bad reaction after vaccine production, clinical experiment of vaccine,etc., resolve these seven blocks into 183 indexes in detail, necessary plurality, through could authorize, adopt, second inside the 183 index, still presume 88 key indexes in 183 indexes. What is named the key index? The key index is an important factor, 88 indexes must be all passed, one can't drop, it so long as have by each through,then reject one ticket, pass country evaluation systems whole, so is so strict. In 1987, in order to guarantee the vaccine that the mechanism of the United Nations was purchased from different channels was safe, World Health Organization has put out " The pre- certification system of vaccine " . If since then, the vaccine products of an enterprise have wanted to enter the United Nations and purchase the catalogue, the ones that must pass WHO " Authorize in advance " ,And enterprises want to apply to authorize to WHO in advance, there is an important precondition, that is: The vaccine supervisory system of this country must pass World Health Organization Approval. Wu Zhen: Unless vaccine standard be raised continuously we during these years, already to what extent is it,Chinese vaccine standard now basically with? ��, prostitute of Yao, entangle Qiang shoulder, rank extensive to imitate 5 ridicule �� of �� ancient drinking vessel the intersection of Guo and the intersection of Li and letter �� amine, enemy of sheath, while being mediocre at the � Poor if you can't take off decayed tooth ��, knock at would like to stare at ��ƪ� s fragrants flurried steal street bits stir-fry before stewing bits of �� of boat last Luo E �� after woulding like to �� Gui protein Shu of �� 1 Guos flurried after woulding like to �������� large bamboo or straw hat with a conical crown and broad brims flurried Poor benevolence sheath billows misty Lang ���֯� Shuo Heavy curtain the intersection of scandium and poor the intersection of decayed tooth and ���� steal, criticize sb's faults frankly � of Du beak distant the intersection of �� and one torr of fish hawks and all of a sudden Actinium � offers as a gift �� ���� sheath steals Fu magnetic �� �� of sheath bridge of ���� Mie play �� Mie ��� persimmons loose wish whether ��� send �� fine �� let out � call out ����� persimmons flurried last Liang ���� a �� happy to would like emperor flurried Peng of �� 1 orangutan after woulding like to �� of bridge of Mou Bits forge the intersection of Liang and the intersection of �� and detailed the intersection of Chu and the intersection of institute and the intersection of large bamboo or straw hat with a conical crown and broad brim and the intersection of ���� and the intersection of quarrel and Huan bare Cha ���� Sun haze �� all to make mow �� residence? Then how on earth is the security of vaccine guaranteed? The reporter comes Chinese food medicines assay the research institute, is responsible for examining the vaccine that every a number of enterprises produce out there, allow, list, sell just after being qualified, we can say there the intersection of vaccine and a line of defence of end that quality safety check on. Wang JunZhi, Chinese food medicines assay the biologicals of research institute and assay the chief expert, he tells reporters, criticizing issuing the system and is not merely in line with international standards of China, here frequently, the standard of the security presumed is even higher than international average level. Chinese food medicines of Wang JunZhi assay the biologicals of research institute and assay the chief expert Wang JunZhi: The standard that vaccine examines is integrated with world, in some projects, in the project of specific security, it is real we require it is stricter than in the world, we for example first vaccine flowing, for example we " First flows " Vaccine,the security one index, it is endotoxic,generally in the world, in the world those is for imported medicine, vaccine imported, 100 units, but we reach 10 units definitely, we think not up to standard if exceeds 10 units. As to the security of Chinese vaccine, World Health Organization is very confident too. It represents Lan RuiMing that blue Rui bright World Health Organization stationed in China: Chinese vaccine supervisory system, has met the requirement of World Health Organization, this means, guarantee vaccine that China produces possesses reliable quality. Reporter: What piece last system is smooth through,can vouch for not telling by wing Bureau of Drugs Supervision Deputy Bureau Director you, our vaccine is safe later. Wu Zhen: We all know, the products are produced out by the product quality, do not supervise out, there are a set of good supervision systems, it is very important that it is safe and effective to guarantee ordinary people, but likewise an important one is to carry out each item of medicines in the production process for producing enterprise strictly, every system and standard of production of medicines require, guarantee the products from the source, in that case, combine with the effective supervisory system, we dare to vouch for talking and resting assured in this medicines. Reporter: In fact we are afraid the safe problem of vaccine is not so good as the question that say it is actually a sense of responsibility, then in what disappearance of this kind of sense of responsibility of keeping a lookout of great intensity does this set of ours control the system? Wu Zhen: It is not enough yet for us to have a set of good supervisory systems, so will strengthen the supervision management of enterprises, enterprises educate, promote the consciousness, initiative of our respect of ensuring the quality of products for producing enterprise, fully play a that they are ensuring the quality of products role, in that case, the whole safe platform of our vaccine may be a bit higher. Then what situation is the production of Chinese vaccine enterprises on earth? The reporter has come to China biotechnology group company, the institute of biological products of Chengdu. China grows the group as the biggest vaccine manufacturing enterprise of China, it exceeds 70% of the vaccine at home to supply, among them, a kind of vaccine is that the national immunity is in the vaccine which the children inoculate free when planned, 85% grow the group to offer from hitting. Have one mouse little in the program, it second the intersection of brain and the intersection of cultivation and parent of vaccine, also fostered out according to the clean requirement of World Health Organization. The dirty things that not only there is no general naked eye to see on it, but also there can't be particular microorganism and parasite yet. In order to train this kind of ground mouse, enterprises are really a lot of setbacks of fee. The director and researcher of the centre of experimental animal of institute of biological products of Chengdu put in summer Put in summer: At that time (the end of the 1990s) The intersection of we and of mouse ordinary, people and the intersection of meningitis and the intersection of virus and such virus of animal need getting rid of, then other bacteria, there are fewer ones that got rid of, that is two kinds. The parasite is one kind. Less because of parasite's quantity of virus of bacterium that is got rid of, may lead to the fact there are safe risks in vaccine. Here at that time, it was the ground mouse of the clean rank that the whole China has not fitted World Health Organization's requirement yet of the end of the 1990s of last century. Put in summer: We import mouse, mother of SPf, from foreign countries, the ordinary place mouse under the intersection of we and the terms, pregnant the intersection of mother and mouse carry on caesarean birth, give birth to the young mouse after the caesarean birth, young mouse after the caesarean birth give abroad importing SPF mouse feed, after this is fed, then set up our own SPF ground mouse's population through this route 2003, the ground mouse's population which accorded with World Health Organization's requirement had at last of Chengdu, present vaccine is that the mouse produced which used such high clean rankly. Put in summer: We set up SPF mouse's population can get rid of four or five kinds of virus, 14 kinds of virus now, 15 kinds of bacteria and 5 kinds of parasites. This kind of quality totally accords with this one that World Health Organization stipulates, but mouse's quality criteria of ground of this SPF that second brain rules stipulate. Has the cleaning degree for producing raw materials guaranteed, how about the clean index of the factory building? In the workshop of vaccine. According to the requirements of standardard management of quality of production of new medicines and World Health Organization of our country, vaccine bottles the room as the most key area, there 3250 0.5 microns size particle in area of each square meters, there 20 5 microns size particle. Assistant manager of operational department Zhao �S's strength of quality of institute of biological products of Chengdu of Zhao �S's strength: Hit an analogy that may not be very appropriate, for example in our toilet, liken the dust particle to of a cherry, may have dozens of cherries too inside our toilet, but may be totally piled, does not totally have any chink in the general room, this plant the state after piling cherries. On the digital screen controlled when real, the particle quantity of dust of the key area, basically steady in the units, well below the standard that World Health Organization requires. Though there are such control system and production environment, how is the inoculation situation in reality of vaccine? Medicine into the peace of Dongcheng District that the reporter has come Health dept. of the institute, are happening to inoculate class II vaccine, only vaccine at one's own expense. The reporter has interviewed several parents at random. Parents 1: We hit seven price vaccine of country in the year before last, are imported too. Parents 2: Import. Parents 3: Let's choose to import. The reason why parents choose to import vaccine, have one's own reasons. Parents 1: Because time is a little longer, some does not want to react and have some experiments, if is domestic, may be just listed and did not dare to let children try. Parents 2: I think I import riper. Parents 3: Think that rest assured about some, domestic vaccine does not feel very safe. The staff members of the anti-epidemic station tell reporters too, generally come to inoculate the parents with vaccine of price, will often choose to import vaccine. Staff members: Generally inoculate more reporters who import vaccine: How much can the proportion have? Doctor: Proportion can in,say whether import you, can at 60% to 80%. The reporter has mentioned the same question to Wu Zhen too. Reporter: If you give to one's own family, or the child comes to inject vaccine to have domestic vaccine and import vaccine now, which one will you choose? Wu Zhen: This does not have anything to choose, there is no doubt. Undoubted domestic vaccine must be used, and should be confident of using. Begin from children are a years old, before 12 -year-old 14 years old, must plan to prevent infectious disease in immunity, immune vaccine of plan is domestic, these seedlings have already been proved by history on this result so for many years, the first is effective, without the result, disease is controlled and can not control, the second is safe, if unsafe, everybody either will go kind, this is that already history has been proved, should say so for many years, everybody has not queried its security either, it is a bad reaction of vaccine that everybody reacts and worries even more. It is mostly a bad reaction to worry, but the practical one says, finally there is difference of the quality between the domestic vaccine and foreign vaccine bad reaction of bad reaction, taking scientific data out till now proves. In fact vaccine of China is never lost on the result of use importing vaccine. The whole world erupt first flow, in reply, shed while fighting specially this by first, China does well 2009, take the lead in, develop, produce, use first flow vaccine, higher than international protection rating of average level realize, inoculate not merely, in the whole world, and the bad reaction rate is lower than vaccine of ordinary influenza. Wu Zhen: The vaccine quality of China is still all right, the reliable one rested assured. We should affirm this. Where is our disparity, our disparity is not in the traditional seedling, our disparity is in two aspects, the first is innovative, innovative vaccine our China is a bit less, all innovate abroad newly, model after us, we are that we are a step later than the household in vaccine of new discovery, everybody feels and grinds better than to model originally after all, a general psychology. In the the investigation, reporter find, a lot of officers in World Health Organization are in first, when shed to prevail of 2009, vaccine flows to inoculate first that China produces. Beautiful the intersection of shirt and World Health Organization Ke stationed in China medical the intersection of officer and beautiful shirt Ke: When first flowed greatly and popularly, I inoculate first flow vaccine is to produce by enterprise a certain of China, and a lot of officers in World Health Organization have inoculated vaccine that China produced. Host: In recent years, the market scale of global vaccine is expanding constantly. The data from clear wooden research center of China of water reveal, the scale that global people use the market of vaccine will be 22,800 million dollars in 2009, increase progressively with 18% of the growth rate every year over the past three years. In the face of this enormous market, though the supervisory system of domestic vaccine has been approved by World Health Organization, but does not mean the enterprises producing vaccine can get this big cake of the international market smoothly? Host: Welcome. The data from World Health Organization reveal, vaccine of 80-100 countries and regions in the world totally relies on the organization of the United Nations to purchase at present. But some big trans-corporations monopolize this market now, and the price remains high all the time. The officers of World Health Organization express, hope the vaccine manufacturing enterprise of China can offer safe vaccine at fair price. Then Chinese vaccine move towards the international market to also need those preparation? China has a manufacturing enterprise of 36 of vaccine at present, it is the largest vaccine producing country in the world, production capacity can be up to producing 1 billion pharmaceuticals per year. Moreover, the advantage that Chinese vaccine is at obvious price yet. Yin Wei the Northeast Beijing department revitalizes general manager of Co., Ltd. Yin WeiDong of the biologicals: You such as our hepatitis A vaccine, we now the intersection of we and Beijing, Tianjin, Shanghai the intersection of government procurement and price the in 30 yuan about in deactivate vaccine hepatitis A by the intersection of Chinese and supply price, it is then three dollars, four dollars, four dollars, five dollars are in this way. But U.S.A. CTC is large purchases prices still in 12 dollars, there is very great difference like this Though quality reaches a standard, the output is sufficient, the price is cheap, but vaccine of China wanders up and down within the country all the time for a long time. XiaoMing Chinese biotechnology general manager of group company Yang XiaoMing Yang: WHO authorizes it is just like a pass, its pre- authentication accords with the international standard, all get each country and obtain the pass through the afterwards, there is not this pass, during the country, for example consult between two countries in the exit of your products, he approves you can export, if does not approve, he can Export. On the other hand, but the demand for vaccine of international market increases day by day. World Health Organization stationed in China medical officers Ke LiShans tell reporters, the annual amount of production of global vaccine is in 10 billion - 15 billion pieces of dosage, vaccine of dosage 3 billion - 4 billion among them will be purchased by the United Nations to supply with 80-100 developing countries. Implement national immunity plan difference with Chinese Government, a lot of the intersection of developing country and vaccine supply with extremely deficient. It is introduced, because lack vaccine, only rotavirus and pneumonia coccus seize about 2 million children's life every year. World Health Organization expects very much the enterprises of China can be through authorizing in advance as soon as possible, add the list that vaccine of the United Nations is purchased. It represents Lan RuiMing that blue Rui bright World Health Organization stationed in China: China offer vaccine in a large amount at the price can be affordedded, it will be right to solve the global vaccine demand, play an enormous role, WHO representative office in China, expects to supervise the administration bureau with national food medicines, and the vaccine manufacturing enterprise of China continues cooperation, let the vaccine which China produces go to the world. But enterprises want to pass generation It is not anything very simple to defend the pre- authentication of organizing, have assessed and just opened a door through authorizing in national supervisory system, more efforts are still in enterprises. Chief of Chengdu institute of biological products Ge YongHong tells we, enterprises, in order to improve the quality of production, and then can apply for the pre- authentication of WHO is 5 years already more diligent. Red chief of Chengdu institute of biological products Ge YongHong forever Ge: Do you see now? Shelf extensive in �ҧС�> shelves angry �� extensive �Ϊ� the sixth of the twelve Earthly Branches alliance �� Wan the Huaihe River short iron rod with 4 edges Shu of �� 1 Guo take off gum Huan sip to assign to what sigh Pies widely different Xuan of prostitute 1 �� neon last Xi �� toad huge rocks polished after lasting ��A hundred million yuan, carry on the transformations of workshop and facility, newly build 11 new factory buildings, we still reconstruct quality management system of ours, guarantee our products can get this effective supervision and quality assurance. Though already took more than 5 years, Ge YongHong still admits candidly, it is almost impossible for enterprises to want and get and authorize in advance in a short time. Ge YongHong: We imagine at the end of this year, or will submit to World Health Organization in this way formally next year one will be authorized in advance, in fact it is a relatively long course to authorize in advance. For example, then a producer which India authorized through WHO, they are a piece of new products, submitted and authorized, they spent the time of seven solid years. Though the vaccine supervisory system of China is authorized through the assessment of WHO, but this is not once and for all. Every three years, WHO will improve the standard, and carry on the revision trial. The reporter knows in the investigation too, because the specific country implements domestic and foreign inconsistent supervision standards, result in losing evaluation in its national supervisory system of World Health Organization to authorize. So, no matter to country or enterprise, the internationalization of vaccine has very long ways to go. Reporter: In can smooth through the intersection of control and system of WHO this time, while you inspire joyful, have thought that has worried? Wu Zhen: Through not meaning we are withourt any sorrow, everything is just fine, sleep without any anxiety, no, the way in the future is long, medicines supervise vaccine of vaccine, the completion and promoting of the system is an eternal subject. Host: In a sense, history that the mankind multiplies and lives is with disease and history that the natural calamity struggles constantly. The discovery of vaccine can be said to be an incident with meaning of the milestone on human development history. Because of the appearance of vaccine, threatening human health and smallpox virus of centuries is eliminated completely. China through the intersection of vaccine and supervisory system of World Health Organization, indicate Chinese oppose level of disease stride forward an important step already. We hope the vaccine manufacturing enterprise of China contain by oneself strictly, will obtain pre- authentication of World Health Organization as soon as possible. This not merely means Chinese enterprises can participate in the competition of the international market, more important, this means vaccine of China is more secure safely. Today's program right away thank your watching for here. (Edit: Director Xiong ManLin: Zhang Qin thinks)

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