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The Food and Drug Administration issued the Quality Management Standards for Non-clinical Drug Research.
2021-09-26
In order to ensure the quality of non-clinical evaluation studies of drugs and ensure the public use of drugs, the State Food and Drug Administration recently issued the newly revised "Quality Management Standards for Non-clinical Studies of Drugs" (Order No. 34 of the State Food and Drug Administration) (hereinafter referred to as the "Standards"). The Code consists of 12 chapters and 50 articles, including general provisions, terms and definitions, organizational structure and personnel, facilities, instruments and experimental materials, experimental systems, standard operating procedures, implementation of research work, quality assurance, data files, client and supplementary provisions. The Regulations will come into effect on September 1, 2017, and the Quality Management Standards for Non-clinical Research of Drugs issued on August 6, 2003 (former Order No. 2 of the State Food and Drug Administration) will be repealed at the same time.
What are the uses of heavy calcium powder?
The heavy calcium powder has abundant resources, wide distribution, simple processing technology, low price and high purity. Therefore, it is usually used as industrial filler. Widely used in artificial floor tile, rubber, plastic, paper, paint, paint, ink, cable, building supplies, food, medicine, textile, feed, toothpaste and other daily chemical industry. In addition, there are many uses of heavy calcium powder, today we will give you a specific explanation of the nature of heavy calcium powder and use in various industries.
POCT technology characteristics and development at home and abroad
POCT products in Europe and the United States are mainly used in clinics, pharmacies, medical emergencies and home monitoring of patients. Compared with the household market, POCT in the medical market has become one of the fast-growing branches in the European and American medical fields, with an annual growth rate of about 10-12%. Its POCT test products mainly focus on some market segments such as blood sugar, blood gas/electrolyte, coagulation, infectious diseases, pregnancy indicators, cardiovascular, tumor, drugs, etc. Among them, blood glucose is a large market in the POCT field, while myocardial markers is a rapidly growing field. Traditional gold chromatography qualitative analysis technology still holds a place in Europe and the United States, mainly focusing on pregnancy, drugs, pathogen antibody detection. With the prevalence and outbreak of some tropical viruses, some new virus antibody detection projects have appeared, such as dengue virus and Zika virus.
32 kinds of domestic medical devices received policy support
On January 31, the Ministry of Industry and Information Technology released a new catalogue of domestic equipment support, also known as the Catalogue of the first major technical equipment Promotion and Application Guidance (2017 version).
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