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Comparative Study Of New Drug Application Procedure In Us, Eu And India
Corresponding Author(s) : B. Shivasai
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 12 No. 4 (2024): 2024 Volume -12 - Issue 4
Abstract
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.
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- http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/
- https://en.wikipedia.org/wiki/New_drug_application
- http://www.investopedia.com/terms/n/new-drug-application-nda.asp
- http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm
- https://en.wikipedia.org/wiki/Abbreviated_New_Drug_Application
- http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/
- http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/
- Mulaje SS, Birajdar SM, Patil BR, Bhusnure OG. Procedure For Drug Approval In Different Countries. Journal of Drug Delivery & Therapeutics; 2013, 3(2), 233-238
- Prajapati Vishal,GoswamiRahulgiri, Makvana Pratik, Badjatya Jitendra Kumar.A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE AND INDIA. International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
- K. P. R. Chowdary, K. Ravi Shankar and G. Saranya. A Comparative Study Of Drug Approval Process In United States, Europe And India. World Journal of Pharmaceutical Research, Volume 4, Issue 7, 419-427.
- U. Nitin Kashyap, Vishal Gupta, H. V. Raghunandan. Comparison of Drug Approval Process in United States & Europe. J. Pharm. Sci. & Res. Vol.5(6), 2013, 131 - 136
- Jatin Patel, Krunal Parikh, Dhiren Shah. New Drug Approval Procedure In India. http://www.pharmatutor.org/articles/new-drug-approval-procedure-india
- Jitendra Badjatya. A Review On Drug Approval Process For Us, Europe And India. International Journal of Drug Regulatory Affairs 04/2014; 2(1):1-11
- http://www.medscape.com/viewarticle/405869_4
- Journal of Drug Delivery & Therapeutics; 2013, 3(2), 233-238.
References
https://en.wikipedia.org/wiki/New_drug_application
http://www.investopedia.com/terms/n/new-drug-application-nda.asp
https://en.wikipedia.org/wiki/Abbreviated_New_Drug_Application
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/
Mulaje SS, Birajdar SM, Patil BR, Bhusnure OG. Procedure For Drug Approval In Different Countries. Journal of Drug Delivery & Therapeutics; 2013, 3(2), 233-238
Prajapati Vishal,GoswamiRahulgiri, Makvana Pratik, Badjatya Jitendra Kumar.A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE AND INDIA. International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
K. P. R. Chowdary, K. Ravi Shankar and G. Saranya. A Comparative Study Of Drug Approval Process In United States, Europe And India. World Journal of Pharmaceutical Research, Volume 4, Issue 7, 419-427.
U. Nitin Kashyap, Vishal Gupta, H. V. Raghunandan. Comparison of Drug Approval Process in United States & Europe. J. Pharm. Sci. & Res. Vol.5(6), 2013, 131 - 136
Jatin Patel, Krunal Parikh, Dhiren Shah. New Drug Approval Procedure In India. http://www.pharmatutor.org/articles/new-drug-approval-procedure-india
Jitendra Badjatya. A Review On Drug Approval Process For Us, Europe And India. International Journal of Drug Regulatory Affairs 04/2014; 2(1):1-11
http://www.medscape.com/viewarticle/405869_4
Journal of Drug Delivery & Therapeutics; 2013, 3(2), 233-238.