• 中国精品科技期刊
  • 中国高校百佳科技期刊
  • 中国中文核心期刊
  • 中国科学引文数据库核心期刊
Advanced Search
JIN Yu, YAO Dongning, SHAO Rong. Development and regulation of biological products in China[J]. Journal of China Pharmaceutical University, 2014, 45(3): 378-382. DOI: 10.11665/j.issn.1000-5048.20140323
Citation: JIN Yu, YAO Dongning, SHAO Rong. Development and regulation of biological products in China[J]. Journal of China Pharmaceutical University, 2014, 45(3): 378-382. DOI: 10.11665/j.issn.1000-5048.20140323

Development and regulation of biological products in China

More Information
  • The development and the status quo of domestic and foreign biopharmaceutical industries are introduced, and the supervision system of biological medicine in China is elaborated. The approval of biologics, the pre-marketing batch-release system for biological products, quality control standards, as well as the post-marketing adverse reaction monitoring system are reviewed, aiming to provide some references for the development and regulation of Chinese biopharmaceutical products.
  • [1]
    Zhan ZS,Ji QS,Pu CY,et al.The development status and prospect of biotechnology drugs[J].J Pract Med Pharm(实用医药杂志),2011,28(2):168-170.
    [2]
    Li G.Global bio pharmaceutical industry prospects in 2012(2012年全球生物制药业前景光明)[N].China Pharm News(中国医药报),2012-03-28(A06).
    [3]
    Wen SM.The global development of the biopharmaceutical industry[J].China Biotechnol(中国生物工程杂志),2006,26(1):92-96.
    [4]
    Wang Y,Wu WJ,Li Q,et al.The research progress and trend of biotech drugs in recent years in China[J].Pharm Biotechnol(药物生物技术),2013,20(1):1-11.
    [5]
    Chang WH,Han P,Cao LZ.The past 30 years and the future of drug registration and R&D in China(1)[J].Chin J New Drugs(中国新药杂志),2010,19(23):2 127-2 131.
    [6]
    Jia LL,Yang Y,Dong GM.Study on improvement of national lot release regulations on biological products[J].Chin Pharm Aff(中国药事),2010,24(6):523-530.
    [7]
    Wang XJ,Cao Y,Guo ZP.The historical evolution of Chinese biological products national standard[J].Chin J Biol(中国生物制品学杂志),2013,26(4):582-584.
    [8]
    Chen XY,Dong Z,Hou YF.The history of security control and adverse reaction monitoring to the marketed Chinese biological product[J].Pharm Biotechnol(药物生物技术),2008,15(5):407-410.
    [9]
    Tang RY,Zhu CH.Analysis of China′s biopharmaceutical industry status quo and development constraints[J].Mod Prev Med(现代预防医学),2011,38(21):4 406-4 408,4 416.

Catalog

    Article views (1337) PDF downloads (2565) Cited by()

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return