A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE AND INDIA
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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References
2. IRA RB, Robert PM. The Pharmaceutical Regulatory Process. 2nd ed. Informa healthcare; 2008. p. 45.
3. Rick NG. Drugs from discovery to approval. 2nd ed. John Wiley & Sons, Inc.; 2008. p. 203-210.
4. IRA RB, Robert PM. The Pharmaceutical Regulatory Process. 2nd ed. Informa healthcare; 2008. p. 46-48.
5. Rick NG. Drugs from discovery to approval. 2nd ed. John Wiley & Sons, Inc.; 2008. p. 212-220.
6. IRA RB, Robert PM. The Pharmaceutical Regulatory Process. 2nd ed. Informa healthcare; 2008. p. 49-51.
7. Clinical Trial & Global Clinical Trial [Internet].[cited 2014 January].Available from: http://cdsco.nic.in/clinical_trial.htm.
8. The New Drug Approval Process [Internet].[cited 2014 January].Available from: http://www.fda.gov/cder/handbook.
9. CDER Guidance: IND application process (interactive session) [Internet].[cited 2014 January].Available from: www.fda.gov/cder/regulatory/applications/ind_page_1.htm.
10. Guidance for industry on preparation of common technical document for import/ manufacture and marketing approval of new drugs for human use. (NEW DRUG APPLICATION–NDA) [Internet].[cited 2014 January].Available from: http://cdsco.nic.in/CTD_Guidance%20-Final.pdf.
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