-
1
-
-
27244459589
-
-
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
-
-
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
-
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
-
-
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
-
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
-
-
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
-
-
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
-
-
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
-
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
-
-
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
-
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
-
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
-
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
-
15
-
-
77954889626
-
-
Ministry of Environment and Forests, India. New Delhi, India: Ministry of Environment and Forests
-
Ministry of Environment and Forests, India. Rules for the Manufacture, Use, Import, Export, and Storage of Hazardous Micro Organisms, Genetically Engineered Organisms or Cells. New Delhi, India: Ministry of Environment and Forests; 1986.
-
(1986)
Rules for the Manufacture, Use, Import, Export, and Storage of Hazardous Micro Organisms, Genetically Engineered Organisms or Cells
-
-
-
16
-
-
0347039637
-
-
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
-
-
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
-
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
-
-
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
-
-
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
-
-
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
-
25
-
-
77954939384
-
-
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
-
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
-
-
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
-
-
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
-
-
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
-
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
-
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
-
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
-
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
-
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
-
-
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
-
-
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
-
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]
-
-
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