Disputes over the registration and approval of health food

Health food registration and approval has been listed in the "non administrative license approval", which has aroused widespread concern As soon as the news of health food registration and approval being listed as "non administrative license approval" by the State Food and drug administration came out, it immediately caused a stir in the industry On February 17 this year, the State Food and Drug Administration released 29 catalogues of administrative approval items, among which the health food registration and approval that attracted much attention was listed in the "non administrative approval", which caused great market attention The reason why this news keeps fermenting in the industry is simple Health food is a big market At the beginning of 2012, in the 12th Five Year Plan for the development of food industry jointly issued by the national development and Reform Commission and the Ministry of industry and information technology, "nutrition and health food" has been identified as the key development food manufacturing industry, with the goal of developing to a scale of 1 trillion in 2015 In 2013, the State Council issued relevant opinions, positioning health food as the supporting industry of health service industry and encouraging vigorous development But now, does it mean the cancellation of the examination and approval system when it is listed as "non administrative examination and approval"? The huge temptation brought by trillion market not only makes the original holders worried, but also makes countless snoops ready to move A senior practitioner of the health food industry in Henan told reporters that according to the current projects disclosed by the State Food and drug administration, the health food administrative approval will become a "non administrative license approval" item, which means that the health food approval certificate will no longer be useful in the future, which is similar to the cancellation of the coal operation certificate in the coal industry last year "If this is the case, it means that the health food approval certificate will lose its legal effect, which is not simply a system or an industry adjustment, but a fundamental change from the deep level of the industry and the industrial investment structure," said the person According to the reporter, supporters of the cancellation of the examination and approval believe that the administrative examination and approval system has developed to this day, and it has gone through nearly 20 years, and its positioning is still unclear For some imported health food, the approval process is lengthy, and the focus is not only safety and functional effect, but also other factors It is obviously difficult for enterprises and products to connect with the market However, some enterprises with a large number of health food approval certificates hold different views They believe that enterprises spent huge human, material and even financial resources to obtain the health food approval certificate before, but now once cancelled, it means that the water has been completely washed away Not only that, opponents also believe that the current approval system sets a high threshold for industry access, and products with "blue hat" (referring to the blue mark with the word "health food") seem to have quality assurance Once the threshold is cancelled, all kinds of capital will be poured into the "cake cutting", which inevitably leads to chaos and disorder in the industry Because of the controversy, so far, the relevant departments have not made a clear statement on whether to cancel the approval Health industry is not "healthy" Although "blue hat" means reliable, according to the reporter, this trillion scale health food market is not very "healthy" The endless illegal addition and false publicity have seriously troubled the development of the industry On June 7, 2013, the State Food and Drug Administration held the "administrative warning meeting on illegal health food advertisements" According to the advertising monitoring data, more than 90% of health food advertisements are false and illegal advertisements Not only that, it has become a very common behavior in the industry to lease the health food qualification to a third party What's more hidden is that in the declaration of "blue hat", a chain of interests has been formed Many so-called intermediaries make profits by selling batches According to statistics, some enterprises have submitted for approval of "blue hat" with various expenses exceeding 10 million yuan In the past 15 years, businesses have spent more than 5 billion yuan accumulatively to approve "blue hat" The high examination and approval cost and time cost make China the country with the strictest entry threshold and the highest cost in the world health food industry Because of this, intermediary has a wide range of market and demand After many efforts, the reporter contacted a senior executive of a southern biopharmaceutical enterprise, whose company has already obtained no less than 10 approval procedures for other enterprises It told reporters that a normal health food approval certificate involves at least 20 steps of approval Every approval requires public relations, which is why such intermediary companies can "moisten" their lives According to him, if a pharmaceutical company wants to launch health food, according to the normal approval process, the queuing time will take 1 to 2 years, and the cost will exceed one million If it is put into operation by a company with such resources and conditions, the speed can be more than doubled and the cost will be much lower "The current price of batch number of health food is generally between 800000 and 1000000, and the price of some more difficult batch numbers will exceed 2 million Some intermediaries are clearly priced, able to provide a full set of data and steps required for approval, and then resell them to enterprises after application, "said the person With the news of health food registration and approval being listed in the "non administrative license approval", the market is also changing Some companies with a large number of batches are "on sale", and the cheapest batch price has "dropped" to about 300000 "In a week, it dropped from 800000 to 300000, which shows how hard the market has been hit," the person said How to supervise has become the focus of attention, "emphasizing examination and approval, ignoring supervision" has become a recognized "feature" of China's health food industry For the interest chain and market chaos formed around the "blue hat", is it possible to eliminate the examination and approval and loosen the industry ties? At present, the biggest role of administrative examination and approval is to raise the entry threshold of new efficacy products, an industry person told reporters If the approval is released, enterprises can claim to have new product functions at will "It's no exaggeration to say that there are now health care products known as anti-cancer products If we let them go, maybe even products that can treat AIDS dare to be put on the table," said the above-mentioned people Moreover, the industry believes that most of the enterprises that can obtain the health food approval certificate at present are large-scale enterprises, such as Tongrentang There are already a large number of health food sold in the market, and the effect is very clear Canceling the administrative approval will impact the products of such enterprises, and at the same time impact the relatively healthy health health food market However, at present, the drawbacks of the current system have emerged In the eyes of many professionals, the reform of health food review and approval system seems to be the general trend How to establish a perfect health food registration system is the key According to reports, in the United States, as long as enterprises submit research data and experimental data, whether a health care product passes or not only takes 75 days to know the answer In addition, European and American countries' monitoring of the industry involves production, circulation, advertising, efficacy and other aspects, and each one is registered For those who violate the rules, the punishment is very strong For the future trend of supervision, the head of Henan District of a pharmaceutical enterprise in Hainan told reporters that from the perspective of industry development, it is suggested to adopt the filing system as the main system, supplemented by administrative examination and approval system "Some common health food can be put on record, while the administrative approval is mainly for the health food with new efficacy, and it should be monitored in an all-round way." Said the person.