China: CDE Rejected 542 Drug Applications Last Year
Accestra Consulting’s Zhao Lu* looks back on a year in which China’s Center for Disease Evaluation (CDE) rejected a record-breaking number of drug applications, explores some of the main reasons…
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BioSino Bio-technology and Science Inc, founded in 1988, is a leading high-technology enterprise whose major national controlling stakeholders comprise the Chinese Academy of Sciences, Beijing Municipal Government and Shanghai Municipal Government. Biosino has already become the largest manufacturer of IVD reagents in China after 20 years development.BioSino successfully finished IPO in GEM of Hong Kong Stock in 2006, symbolizing that she has marched away for her globalization, grouping and synthesis of running both products and capital. Now, Biosino has 90 IVD products, more than 200 formats including biochemistry diagnostic reagents, immunology diagnostic reagents and rapid tests. Lots of our products have got CE mark and more products are in the process of application. Now, BioSino has developed over 600 distributors and retailers over the country, occupy 75% of the Chinese market. Moreover, we have exported to over 20 countries from Southeast Asia, Middle-east, North Africa, and South America.In order to ensure consistently high quality, BioSino built a new GMP standard plant (11000m2) and established a microcomputer-controlled automated production line to achieve a completely sealed, sterile, temperature and humidity controlled environment. At the same time, meticulous and experienced employees are hired for quality control, technological safeguards and production operations. Each step is strictly in accordance with the requirements of quality control standards ISO9001:2000 and ISO13485:2003.BioSino has a professional after sales service team comprising experts in the field of biochemistry, immunology, pharmacy and medicine. We provide on-the-spot technological support and service to our customers, teach them how to use our products and resolve problems they meet. Our commitment is to provide the best service at the first moment.Looking into the future, BioSino will keep on developing new products to meet the demands of international markets. Our aim is to become a leading diagnostic manufacturer in the world and create a better future together with our partners and customers.
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