Recently, the National Medical Device Supervision and Management Work Conference was held in Beijing. Food and drug supervision and party style and clean government construction are still one of the main contents of the meeting. The detailed summary and future deployment of medical device supervision and management work is worthy of attention.
At the beginning of the new year, will the General Administration of Food and Drugs transfer the focus of work from drug registration supervision to medical devices? What is the current status of China's medical device industry ? Is the water in the medical machinery industry “deep and mixed� Will the medical machinery industry face a reshuffle? The author wants to talk about personal opinions here.
Looking back at 2015, what happened in the medical machinery industry?
In terms of policies and regulations, the National Bureau issued the "Opinions on Reforming the Approval System for Drug Medical Device Evaluation and Approval", "Measures for Drug Medical Device Flight Inspection", and "Medical Device Classification Rules" in 2015. The "Opinions" opened the curtain of the reform of the review and approval system for pharmaceuticals, so that product safety, effectiveness, quality controllability and international standards are further integrated, and the quality of drug review and approval is improved. The "Measures" states that food and drug supervision and management The department has the right to inspect the development, production, operation, use and other places of the inspected unit at any time for inspection. The unit under inspection shall not refuse or evade; and the "Rules" combines the experience accumulated in the classification of medical devices, after in-depth investigation and extensive solicitation. Comments, some of the terms and classification decisions have been refined.
In terms of industry layout, there are 14,151 medical device manufacturers in the country, which is less than 1,000 in 2014. A small number of small and low-level enterprises have withdrawn from the historical stage, and the government's decentralization has helped a number of advantages. The company is lightly loaded and expands its product structure and marketing channels through independent innovation and capital operation, and deploys a large health industry. Many enterprises have made great progress in economic growth through transformation, restructuring, and mergers and acquisitions. At the same time, the situation of “distribution, chaos, and small†in China's medical machinery industry is gradually being broken.
The shortcomings behind the gratifying results
While the medical machinery industry is developing rapidly, we have to pay attention to the shortcomings behind the rapid development. False registration and declaration, illegal production, illegal operation, exaggeration of publicity, use of unlicensed products and other illegal and illegal activities are brewing and fermenting.
Regarding the registration of threshold entry, the number of “notices on the publication of non-registration approvals†issued by the General Administration of Food and Drugs is often alarming. There are only 490 acceptance numbers that will not be registered on the 22nd of this month, and 402 acceptance numbers will not be registered on the 15th. A large number of unregistered documents reflect that China's medical machinery industry is not developing enough products for its products, and the attitude is not serious enough. The company also reported that it is a matter of ignorance and thoroughness. The author hereby advises that the rectification of drug registration data fraud has been The medical equipment market has sounded the alarm, it is time to think about the future development!
In the event of adverse reactions after medical access, the number of reports of medical device adverse events in the country reached 260,000 in 2014, and the average number of million people reported reached 198. Among them, 98 death-related adverse events were reported, and more than 40,000 serious injury incidents were reported, accounting for 15.5% of the total number of suspected adverse events reported, an increase of 18.6% over 2013. This also refers to any harmful events that occur or may occur in the normal use of qualified medical devices that are not related to the intended use of medical devices, and the serious consequences of accidents that occur in medical devices that enter the market illegally. Imagine it.
Intermediate – Intermediate: A material produced during a drug substance processing step that must undergo further molecular modification or refinement to become a drug substance. Intermediates may or may not be isolated. Intermediates are the key products of the previous process of making APIs, which are different in structure from APIs.
for example:
Amoxicillin capsules are called preparations, amoxicillin is called API, and 6-APA is called intermediate.
Ceftriaxone sodium powder is called preparation, sterile ceftriaxone sodium is called API, and 7-ACA is called intermediate.
Our company specializes in providing key intermediates for various APIs
Intermediate is a very important type of fine chemical products. Its essence is a type of "semi-finished product", which is an intermediate product in the production of certain products. For example, if a product is to be produced, it can be produced from intermediates, saving costs and reducing It is widely used in the synthesis of medicines, pesticides, coatings, dyes and spices. In the field of medicine, intermediates are an important link in the industrial chain of the pharmaceutical industry. They are used for some chemical raw materials or chemical products in the process of drug synthesis. In a word, they are used to produce APIs.
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