DRUG APPROVAL PROCESS: A CONTRASTIVE APPROACH

  • Pankaj Kashyap
  • Eshant Duggal
  • Vikaas Budhwaar
  • Dr. Arun Nanda
  • Jitendra Kumar Badjatya

Abstract

The drug approval process is the vehicle through which drug sponsors formally approve a new pharmaceutical for sale and marketing. The goals of the approval process are to provide enough information about the drug safety and efficacy in human beings.  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. The approval process starts with preclinical testing. For drugs that appear safe, an investigational new drug application (IND) is filed. If approved, clinical trials begin with phase 1 study that focus on safety and pharmacology. Phase 2 studies examine the effectiveness of the compound. Phase 3 is the final step before submitting a new drug application to the authority. A New Drug Application (NDA) contains all the information obtained during all phases of testing. Phase 4 studies, or post-marketing studies, are conducted after a product is approved.

Keywords: Drug approval process, NDA, IND, Clinical trial, Marketing authorization.

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References

1. The Drug Approval Process: Drug Development – Medscape [Internet]. [cited 2013 May 23] Available from:
http://www.medscape.com/viewarticle/405869_4‎.
2. New Drug Approval Process: Regulatory View - Pharmainfo.net [Internet]. [cited 2013 May] Available from:
http://www.pharmainfo.net/reviews/new-drug-approval-process-regulatory-view‎
3. The U.S. Drug Approval Process: A Primer [Internet]. [cited 2013 March] Available from:
http://www.thememoryhole.org/crs/more-reports/RL30989.pdf
4. The New Drug Approval Process. [Internet]. [cited 2013 May] Available from: http://www.fda.gov/cder /handbook.
5. Investigational New Drug (IND) Application [Internet]. [cited 2013 May] Available from:
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelope.
6. CDER 2007 Update - Food and Drug Administration [Internet]. [updated 2007; cited 2013 Mar 23]; Available from:
http://www.fda.gov/downloads/AboutFDA/.../CDER/.../UCM121704.pdf‎‎.
7. Dulichand R, Harish D. New Drug Approval Process: Regulatory View. [Internet]. [cited 2013 May] Available from:
http://www.pharma info.net/reviews/new-drug-approval-process-regulatory-view.
8. Investigational New Drug Application (IND) [Internet]. [cited 2013 May] Available from: http://www1.pointcross.com/source/ddg/steps/ind/index.html.
9. Drug Approvals and Databases >Drugs@FDA Glossary of Terms [Internet]. [cited 2013 March] Available from: http://www.fda.gov/drugs/ informationondrugs /ucm079436.htm‎l.
10. Drug Approval Process- USA vs INDIA [Internet]. [cited 2013 July] Available from:
http://www.pharmainfo.net› Blogs › santosh kumar.JH's blog‎.
11. Mulaje SS, Birajdar SM, Patil BR, Bhusnure OG. Procedure for drug approval in different countries: A Review. Journal of Drug Delivery & Therapeutics. 2013; 3(2): 233-8.
12. European Medicines Agency [Internet]. [cited 2013 July] Available from: http://www.ema.europa.eu/‎.
13. How New Drugs are Approved in Europe [Internet]. [cited 2013 April] Available from: http://www.marsdd.com/.../How_New_Drugs_Are_Approved_in_Europe.pdf‎.
14. Regulatory One: Drug Approval Procedures in European Union [Internet].[cited 2013 May] Available from:
http://www.regulatoryone.com/.../drug-approval-procedures-in-european.html‎.
15. Marketing Authorization Procedures in the European Union - SGS [Internet].[cited 2013 July] Available from:
http://www.sgsgroup.fr/~/.../SGS-Clinical-Marketing-Authorization-EN-09.pdf‎.
16. Procedures for drug approval - CHMP - Course in Pharmaceutical [Internet].[cited 2013 July]
Available from: http://www.pharmaceutical-medicine.org/.../sigtuna _080917_ljungberg. pdf‎.
17. How New Drugs are Approved in Europe [Internet].[cited 2013 June] Available from:
http://www.marsdd.com/...PDFs/How_New_Drugs_Are_Approved_in_Europe.
18. The Mutual Recognition Procedure - European Commission [Internet].[cited 2013 May] Available from:
http;//www.ec.europa.eu/health/authorisation-procedures-mutual-recognition_en.htm‎‎l.
19. The Centralised Procedure - European Commission [Internet].[cited 2013 March] Available from:
http://ec.europa.eu/health/authorisation-procedures-centralised_en.htm‎l.
20. The Decentralised Procedure - European Commission [Internet].[cited 2013 July] Available from:
http://ec.europa.eu/health/authorisation-procedures-decentralised_en.html.‎
21. Clinical Trial & Global Clinical Trial [Internet].[cited 2013 July] Available from:
http://www.cdsco.nic.in/clinical_trial.html.
22. New drug approval procedure in India Pharma Tutor [Internet].[cited 2013 March] Available from:
http://www.pharmatutor.org/articles/new-drug-approval-procedure-india‎.
23. Gupta N V, Reddy C M, Reddy K R, Ajay Kulkarni R A, Shivakumar H G. Process of approval of new drug in India with emphasis on clinical trials. ISSN 0976 – 044X, 2012; 13 (2): 17-24.
24. CDSCO - Guidance for Industry – Central Drugs Standard Control Organisationon Submission of Clinical Trial Application for Evaluating Safety and Efficacy [Internet].[cited 2012 Dec] Available from:
http://www.cdsco.nic.in/CDSCO-GuidanceFor Industry.pdf‎.
25. Process of approval of new drug in India [Internet].[cited 2013 July] Available from:http://www.globalresearchonline.net/journalcontents/v13-2/004.pdf‎.
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How to Cite
Kashyap, P., E. Duggal, V. Budhwaar, D. A. Nanda, and J. K. Badjatya. “DRUG APPROVAL PROCESS: A CONTRASTIVE APPROACH”. International Journal of Drug Regulatory Affairs, Vol. 1, no. 2, Feb. 2018, pp. 11-19, doi:10.22270/ijdra.v1i2.107.