IVD industry: looking forward to the healthy development under scientific supervision!
Attribute：Industry News Date：2019-09-03 15:45:23
"For in vitro diagnostic reagents, we are going to establish a management mode that is different from drugs and medical devices, and manage in vitro diagnostic reagents as a separate product. We must not hinder the development of in vitro diagnostic reagent industry because of the backward management mode. " Recently, the relevant leaders of the State Food and Drug Administration (SFDA) said at the "seminar on the management of in vitro diagnostic reagents". This means that there will be a major change in the management mode of in vitro diagnostic reagents in China, and the introduction of relevant regulations is just around the corner.
For in vitro diagnostic reagent manufacturers, this is undoubtedly a long-awaited good news.
Market: rapid global growth
In recent years, the rise and integration of various new technologies and methods have promoted the development, application and upgrading of in vitro diagnostic reagents. At the same time, with the increase of income and the improvement of living standards, people have a higher demand for health and medical quality. All of these make the global market of in vitro diagnostic products continue to expand. "At present, the market of in vitro diagnostic reagents is increasing by more than 12% every year, and it is estimated that the output value of in vitro diagnostic products in the world will reach 17 billion to 20 billion US dollars in 2006," the relevant person of Shanghai Industrial Kehua Biotechnology Co., Ltd. told the reporter
Relevant data show that in 2002, the global market sales of in vitro diagnostic reagents reached 7.3 billion US dollars, and its growth rate is expected to remain at 16.6% in five years, far higher than the average growth rate of 10% in the global pharmaceutical market. At present, the market scale of in vitro diagnostic reagents in China is about 3-4 billion yuan, with an annual growth rate of 20% - 30%, which is much higher than that of developed countries such as Europe and the United States. However, due to its late start, the in vitro diagnostic reagent industry in China has some problems, such as small scale, single product and so on. Some powerful multinational companies (such as Roche, Abbott) occupy a considerable share in the market of in vitro diagnostic reagents in China.
Enterprise: once distressed and helpless
However, no matter local enterprises or multinational companies, the management of in vitro diagnostic reagents in China has a lot of difficulties. In the early 1990s, due to too many manufacturers, the competition in the diagnostic reagent market became white hot, the product quality was uneven, and the market order was extremely chaotic. In 1993, the relevant departments of the state began to rectify the situation and gradually curb the disorderly competition. Since the establishment of the former State Drug Administration (SDA), China has further strengthened the management of the industry. In July 2001, SDA issued the "notice on standardizing the management of in vitro diagnostic reagents", which divided the in vitro diagnostic reagents into two categories according to random and non random management; in September 2002, SDA issued the "notice on the implementation of classification management of in vitro diagnostic reagents" (i.e. order 324), which managed in vitro biological diagnostic reagents according to drugs, in vitro chemical and biochemical diagnostic reagents, etc Other types of diagnostic reagents are managed as medical devices.
Dong Tongyi, vice president of the medical laboratory industry branch of the National Health Industry Enterprise Management Association, said: "this classification method is not suitable for the actual situation of in vitro diagnostic reagents in China." Compared with other drugs, sales of IVD reagents are not very large, and many drug operators are not keen on selling IVD reagents. Therefore, in vitro diagnostic reagents are mostly distributed by medical device operators. He believes that this is a naturally formed business channel, but because there is no drug business license, many in vitro diagnostic reagents approved by drugs cannot be sold legally by medical device operators. If drug operators are unwilling to sell, medical device operators cannot sell, and there is a clinical demand, it is inevitable that someone will operate illegally.
In fact, medical device operators can also operate this kind of in vitro diagnostic reagents, but according to the regulations, they must apply for a drug trading license, which brings about a new problem that enterprises need to pass GSP certification. It is not cost-effective for the operators of in vitro diagnostic reagents to increase additional costs on the basis of small profits, and the requirements of GSP are too strict for in vitro diagnostic reagent enterprises.
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