So that only drugs dissolve in the intestine. 'Original drug manufacturers generally have multiple patented process recipe.' Vice President of China Pharmaceutical Quality Management Association MEET 'financial' reporters, the new drug patent term is 20 years, and pharmaceutical companies in the compound, drug patents expire after formulation process also has a patent will expire after a few years, a move that allows the use of patented drugs deadline be extended. In addition, pharmaceutical excipients plays a more critical role. Accessories, most of polymer materials, there is a certain molecular weight distribution, rather than a single component, which means that the content is difficult to use simple indicators detect it. Thus, the name of the same materials, if produced by different companies, product differentiation may be large. There are some varieties of accessories, such as the emergence of one or more specific impurities, which will produce pharmacological effects of uncertainty in the environment, leading to security risks. The US Food and Drug Administration (FDA) regulations, when generic drugs for approval, also need to declare the materials used in medicines, and materials production enterprises manufacturing practice certificate (GMP) and inspection reports (COA), to provide analytical data. But China is not yet rigorous supervision of the excipients. 2006 introduction of the 'pharmaceutically acceptable excipient GMP', there is no compulsory certification. Zhejiang, a pharmaceutical research and development director told the 'Financial' reporter, some pharmaceutical companies in order to save costs in the drug approval procedures, to regulatory authorities to declare a high-quality accessories manufacturers entering the production chain, replace the cheap, inferior quality manufacturers. And even listed in the drug made before and after, not normally be required to test again. China is a major exporter of raw materials and the production of drugs, but a serious shortage of materials research and development, new pharmaceutical excipients almost entirely dependent on imports. Zhang will be told the 'Financial' reporter, many domestic generic pharmaceutical companies use different materials original drug production, which is one of the reasons leading to generic and original drug efficacy differences. September 2014 blockbuster 'poison capsule' incident on the incident in the accessories. Case, Zhejiang, a medicinal materials production with industrial pharmaceutical gelatin capsules into the pharmaceutical companies, resulting in 90 million chromium exceeded capsules drugs into the market. 'Poison capsule' event is extremely lax control accessories
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