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Volumn 44, Issue 1, 2010, Pages 55-67

Biogeneric regulatory policies in China and India: A comparison study

Author keywords

Biogeneric regulation; China; DCGI; India; SFDA

Indexed keywords

ALPHA2B INTERFERON; GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; RITUXIMAB; VACCINE;

EID: 77954900211     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286151004400107     Document Type: Review
Times cited : (5)

References (40)
  • 1
    • 27244459589 scopus 로고    scopus 로고
    • Beijing, China: National Law of the People's Republic of China
    • Drug Administration Law. Beijing, China: National Law of the People's Republic of China; 2001.
    • (2001) Drug Administration Law
  • 2
    • 77449133853 scopus 로고    scopus 로고
    • State Food and Drug Administration, China. Beijing, China: State Food and Drug Administration
    • State Food and Drug Administration, China. Provisions for Drug Registration. Beijing, China: State Food and Drug Administration; 2007.
    • (2007) Provisions for Drug Registration
  • 3
    • 77954943792 scopus 로고    scopus 로고
    • Insider analysis: China's new drug and device measures - Real politics
    • August 20, Accessed August 3, 2008
    • Yang C, Bass S. Insider analysis: China's new drug and device measures - real politics. PharmAsia News [serial online]. August 20, 2007. http://fdcalerts.typepad.com/asia/2007/08/insider-analysi.html. Accessed August 3, 2008.
    • (2007) PharmAsia News [Serial Online]
    • Yang, C.1    Bass, S.2
  • 4
    • 84881604591 scopus 로고    scopus 로고
    • Beijing, China: National Law of the People's Republic of China
    • Patent Law of the People's Republic of China. Beijing, China: National Law of the People's Republic of China; 2009.
    • (2009) Patent Law of the People's Republic of China
  • 5
    • 79953887548 scopus 로고    scopus 로고
    • China passes patent law amendments
    • January 7, Accessed January 14, 2009
    • Ollier P, Qu J. China passes patent law amendments. Managing Intellectual Property [serial online]. January 7, 2009. http://www.managingip.com/Article/ 2078784/China-passes-patent-law-amendments-full-version.html?ArticleId=2078784. Accessed January 14, 2009.
    • (2009) Managing Intellectual Property [Serial Online]
    • Ollier, P.1    Qu, J.2
  • 6
    • 77954899159 scopus 로고    scopus 로고
    • October 29, Accessed January 12, 2009
    • China raises threshold for drug GMP certification. Xinhua. October 29, 2007. http://news.xinhuanet.com/english/2007-10/29/content-6972050.htm. Accessed January 12, 2009.
    • (2007) China Raises Threshold for Drug GMP Certification
  • 7
    • 77954917850 scopus 로고    scopus 로고
    • China. December 12, Accessed January 12, 2009
    • WHO and SFDA jointly hold drug GMP inspector training course. State Food and Drug Administration, China. December 12, 2008. http://former.sfda.gov.cn/ cmsweb/webportal/W43879537/webportal/W43879541/A64029226.html. Accessed January 12, 2009.
    • (2008) WHO and SFDA Jointly Hold Drug GMP Inspector Training Course
  • 8
    • 77954925487 scopus 로고    scopus 로고
    • State Food and Drug Administration, China. Beijing, China: State Food and Drug Administration
    • State Food and Drug Administration, China. Good Clinical Practice of Pharmaceutical Products. Beijing, China: State Food and Drug Administration; 2003.
    • (2003) Good Clinical Practice of Pharmaceutical Products
  • 9
    • 77954907613 scopus 로고    scopus 로고
    • Tougher standards for Chinese pesticide makers
    • February 13, Accessed January 12, 2009
    • Jia H. Tougher standards for Chinese pesticide makers. Chemistry World [serial online]. February 13, 2008. http://www.rsc.org/chemistryworld/News/2008/ February/13020801.asp. Accessed January 12, 2009.
    • (2008) Chemistry World [Serial Online]
    • Jia, H.1
  • 10
    • 77954931693 scopus 로고    scopus 로고
    • State Food and Drug Administration. April Accessed January 12, 2009
    • Li J. Progress of Chinese drug GMP's. State Food and Drug Administration. April 2008. http://www.pmda.go.jp/eaprs-HP-2008/presen/0414-B1-03.pdf. Accessed January 12, 2009.
    • (2008) Progress of Chinese Drug GMP's
    • Li, J.1
  • 11
    • 77954930667 scopus 로고    scopus 로고
    • Clinical Trials in China
    • Accessed July 16, 2008
    • Ding J. Clinical Trials in China. Fifth IFPMA Asian Regulatory Conference. March 2008. http://www.ifpma.org/arc-2008/index.php%3FeID%3Dtx- nawsecuredl%26u%3D0%26file%3Duploads/media/Ding-GDD-Breakout-1. pdf%26t%3D1220072616%26hash%3D1940767526b80e5dellda7b0eb575d07+ china+clinical+trials+phase+I+20+patients+phase+II+Phase+III+200+patients& hl=en&ct=clnk&cd=3&gl=us. Accessed July 16, 2008.
    • Fifth IFPMA Asian Regulatory Conference. March 2008
    • Ding, J.1
  • 12
    • 77954910921 scopus 로고    scopus 로고
    • Clinical trials in China: Opportunities and challenges
    • March 2, Accessed July 19, 2008
    • Wu X. Clinical trials in China: opportunities and challenges. Johnson and Johnson Global Clinical Operations. March 2, 2007. http://brightechintl.com/ Clinical-Trials-in-China-WXY.ppt. Accessed July 19, 2008.
    • (2007) Johnson and Johnson Global Clinical Operations
    • Wu, X.1
  • 14
    • 34247615062 scopus 로고    scopus 로고
    • Biosimilars jumpstart biotech in India
    • April 15, Accessed July 19, 2008
    • Motwani N. Biosimilars jumpstart biotech in India. Genetic Engineering and Biotechnology News [serial online]. April 15, 2007. http://www.genengnews. com/articles/chitem.aspx?aid=2099&chid=4. Accessed July 19, 2008.
    • (2007) Genetic Engineering and Biotechnology News [Serial Online]
    • Motwani, N.1
  • 16
    • 0347039637 scopus 로고
    • New Delhi, India: National Law of the Republic of India
    • Drugs and Cosmetics Act and Rules. New Delhi, India: National Law of the Republic of India; 1940.
    • (1940) Drugs and Cosmetics Act and Rules
  • 17
    • 77954943113 scopus 로고    scopus 로고
    • Accessed January 12, 2009
    • Pacific Bridge Medical. Quality standards: India. 2008. http://www.pacificbridgemedical.com/services/regulatory/quality/india.html. Accessed January 12, 2009.
    • (2008) Quality Standards: India
  • 18
    • 84951719266 scopus 로고    scopus 로고
    • Schedule M was a hasty decision
    • September Accessed January 12, 2009
    • Jaisankar TS. Schedule M was a hasty decision. Express Pharma [serial online]. September 2007. http://www.expresspharmaonline.com/20070915/ management05.shtml. Accessed January 12, 2009.
    • (2007) Express Pharma [Serial Online]
    • Jaisankar, T.S.1
  • 19
    • 77954893140 scopus 로고    scopus 로고
    • National GLP Compliance Monitoring Authority. New Delhi, India
    • National GLP Compliance Monitoring Authority. http://dst.gov.in/ scientific-programme/td-glp.htm. New Delhi, India: Department of Science and Technology; 2005.
    • (2005)
  • 20
    • 77954924811 scopus 로고    scopus 로고
    • March 25, Accessed January 21, 2009
    • WHO GMP plants in India may have to adopt GDP soon. PharmaBiz. March 25, 2004. http://www.pharmabiz.com/article/detnews.asp?articleid= 21085§ionid=50. Accessed January 21, 2009.
    • (2004) WHO GMP Plants in India May Have to Adopt GDP Soon
  • 21
    • 77954945858 scopus 로고    scopus 로고
    • Accessed July 24, 2008
    • Dey B. Biogenerics in perspective. Pharma Biz. http//www.pharmabiz.com/ redfr.asp?fn=/specials/2ndAnniv02/Spfeat0008.asp. Accessed July 24, 2008.
    • Biogenerics in Perspective
    • Dey, B.1
  • 22
  • 25
    • 77954939384 scopus 로고    scopus 로고
    • Genetic Engineering Approval Committee. New Delhi, India: Department of Forests and Wildlife
    • Genetic Engineering Approval Committee. List of Pending GEAC Proposals as of 30.3.2006. New Delhi, India: Department of Forests and Wildlife; 2006.
    • (2006) List of Pending GEAC Proposals As of 30.3.2006
  • 26
    • 77954931371 scopus 로고    scopus 로고
    • CPCSEA issues notices to medical and educational institutes
    • November 2, Accessed July 21, 2008
    • Vasdev K. CPCSEA issues notices to medical and educational institutes. Tribune News Services [serial online]. November 2, 2006. http://www. tribuneindia.com/2006/20061ten3/punjabl.htm. Accessed July 21, 2008.
    • (2006) Tribune News Services [Serial Online]
    • Vasdev, K.1
  • 28
    • 77954923181 scopus 로고    scopus 로고
    • September 10, Accessed July 24, 2008
    • Law Office of Sheela Murthy. Courier Services and Custom Regulations. September 10, 2000. http://www.murthy.com/resource/iacour.html. Accessed July 24, 2008.
    • (2000) Courier Services and Custom Regulations
  • 29
    • 51049120593 scopus 로고    scopus 로고
    • New Delhi, India: National Law of the Republic of India
    • The Patents (Amendment) Act, 2005. New Delhi, India: National Law of the Republic of India; 2005.
    • (2005) The Patents (Amendment) Act, 2005
  • 30
    • 77954944470 scopus 로고    scopus 로고
    • Government of India. New Delhi, India: Government of India
    • Government of India. The Patents Act, 1970. New Delhi, India: Government of India, 2008.
    • (2008) The Patents Act, 1970
  • 31
    • 84996213074 scopus 로고    scopus 로고
    • Plan linking generics to patents is buried
    • July 8, Accessed July 25, 2008
    • Shirvastava B. Plan linking generics to patents is buried. LiveMint [serial online]. July 8, 2008. http://www.livemint.com/2008/07/08004316/Plan- linking-generics-to-paten.html. Accessed July 25, 2008.
    • (2008) LiveMint [Serial Online]
    • Shirvastava, B.1
  • 32
    • 77954947373 scopus 로고    scopus 로고
    • Delhi HC debarred generic drugmakers from marketing
    • January 8
    • Singh K. Delhi HC debarred generic drugmakers from marketing. The Economic Times. January 8, 2009.
    • (2009) The Economic Times
    • Singh, K.1
  • 33
    • 84996166787 scopus 로고    scopus 로고
    • Ex parte order to Bristol-Myers setback to Indian drug industry?
    • January 12
    • Unnikrishnan CH, Pandeya R. Ex parte order to Bristol-Myers setback to Indian drug industry? Livemint [serial online]. January 12, 2009.
    • (2009) Livemint [Serial Online]
    • Unnikrishnan, C.H.1    Pandeya, R.2
  • 34
    • 77954948629 scopus 로고    scopus 로고
    • An important win for domestic pharma industry
    • June 4, Accessed July 26, 2008
    • Hiddleston S. An important win for domestic pharma industry. The Hindu [serial online]. June 4, 2007. http://www.thehindu.com/2007/06/04/stories/ 2007060401361300.htm. Accessed July 26, 2008.
    • (2007) The Hindu [Serial Online]
    • Hiddleston, S.1
  • 36
    • 77954921462 scopus 로고    scopus 로고
    • Data exclusivity - The Indian perspective
    • September 21, Accessed August 3, 2008
    • Nair MS. Data exclusivity - the Indian perspective. LexOrbis: Intellectual Property Practice. September 21, 2004. http://www.mondaq.com/ article.asp?articleid=28531. Accessed August 3, 2008.
    • (2004) LexOrbis: Intellectual Property Practice
    • Nair, M.S.1
  • 37
    • 77954943434 scopus 로고    scopus 로고
    • LexCousel Law Offices. November 22, Accessed August 4, 2008
    • Adebare A. Data exclusivity: the implications for India. LexCousel Law Offices. November 22, 2005. http://www.articlealley.com/article-16562-16.html. Accessed August 4, 2008.
    • (2005) Data Exclusivity: The Implications for India
    • Adebare, A.1
  • 38
    • 77954919819 scopus 로고    scopus 로고
    • Government of India. New Delhi, India: Government of India
    • Government of India. National Biotechnology Regulatory Bill. New Delhi, India: Government of India; 2008.
    • (2008) National Biotechnology Regulatory Bill
  • 39
    • 77954945859 scopus 로고    scopus 로고
    • India drafts plan for national biotechnology regulatory authority
    • July Accessed July 26, 2008
    • India drafts plan for national biotechnology regulatory authority. Asian Medical Newsletter [serial online]. July 2008. http://www.pacificbridgemedical. com/newsletter/v8n7a2blurb.htm. Accessed July 26, 2008.
    • (2008) Asian Medical Newsletter [Serial Online]


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.