2015 years ago all listed drugs will be electronic supervision
Author:admin  From:The Internet   Time:2013-11-18 19:29:40  View:2532

According to the voice of China "national news broadcast" report, the third session of China's biological industry conference opening today, the government of China and the United States, multinational and local drug firms to explore the management and development of the biological pharmaceutical market. CFDA says, will be 2015 years ago to the smallest of all the listed drugs packaging electronic regulation.

At present, the biotech drugs have been widely used in the treatment of cancer, AIDS and other major diseases and rare diseases such as cystic fibrosis. Although China take the lead in developing H1N1 flu vaccine and hepatitis a vaccine and other biological agents, but $70 billion pharmaceutical market in our country, the proportion of biological agents and similar drugs was only 10%. According to the United States ambassador to China Gary Locke, approval process is too long, to a certain extent, affected the rapid development of China's biological pharmaceutical market.

Locke: according to an industry report, a new drug approval in China, mean slow 5 years than the international market. Drug clinical trial application in China, an average of 19-22 months to approved, far behind that of South Korea, even China's Hong Kong region. These factors will seriously affect the multinational companies to China into its new drug test range.

China's drug regulatory "yan" character overhead, state drug supervision administration group members and said, this trend will continue.

And a: the years 2015 to full implementation of the electronic supervision for all listed drugs, achieve the minimum package for all drugs can be carried out to track, realize the whole process of drug quality tracking. In the implementation of the new pharmaceutical production enterprise of all medicines GMP (drug production quality management specification), before the end of 2013 forcing blood products, vaccines, sterile drugs meet the new GMP requirements, forced all the other drug classes at the end of 2015 all reached the requirements of the new drug GMP production.


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