Drug approval process in India and Europe

  • S P Yamini Kanti
  • Ildiko Csoka
  • Amrish Chandra
  • Vikesh Kumar Shukla

Abstract

Every time a new drug is developed it requires a great amount of research work in manufacturing, Pre- clinical Science, Controls, Chemistry & Clinical trials. Regulatory agencies have Drug Reviewers who has the responsibility of checking that whether the data supports the Safety, Effectiveness and Quality control of a New Drug product to serve the public health. Every country has its own Regulatory agency which is responsible for regulating all the Rules and Regulations and forms the guidelines for regulating the Manufacturing, Processing and Marketing of the Drugs. This Article focuses on Drug Approval Process in Europe and India.

Keywords: Drug approval, Clinical Trial, MAA, CDSCO, Centralized procedure, Mutual recognition procedure, Decentralized procedure, National procedure

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References

1. EU Regulatory Procedures [Internet]. TOPRA [cited 2019 Feb 01]. Available from:
http://www.topra.org/CMDownload.aspx?ContentKey=6ef6c81e-c2ff-4328-862a-91ab46d2ccc8&ContentItemKey=80f9589e-93b9-4582-8788-0952193f9004.
2. Rick N G. Drugs from discovery to approval. 2nd ed. John Wiley & Sons Inc.; 2008.p.203-210, 212-220.
3. IRA RB, Robert PM. The Pharmaceutical Regulatory Process. 2nd ed. Informa healthcare; 2008.p.45-51.
4. Vhora I, Patil S, Bhatt P, Misra A. Protein and Peptide-drug conjugates: an emerging drug delivery technology. Advances in protein chemistry and structural biology. 2015; 98:1-55.
5. The European regulatory system for medicines [internet]. EMEA; 2019 [cited 2019 Jan 02]. Available from:
www.ema.europa.eu/en/documents/leaflet/european_regulatory_system_medicines_european_medicines_agency_consistent_approach_medicines_en.pdf.
6. Drug approval process in Europe [Internet]. Authorstream [cited 2019 Feb 03]. Available from:
www.authorstream.com/presentation/krishnalamror-1834879-drug-appruval-process-europe/.
7. Clinical and Global Clinical Trial [Internet]. CDSCO ;2019 [cited 2019 Feb 04]. Available from:
http://cdsco.nic.in/Clinical_trial.htm.
8. Yewale C, Baradia D, Patil S, Bhatt P, Amrutiya J, Gandhi R, et al. Docetaxel loaded immunonanoparticles delivery in EGFR overexpressed breast carcinoma cells. Journal of Drug Delivery Science and Technology. 2018; 45:334-45.
9. CDER Guidance: IND application process (interactive session) [Internet]. FDA [cited 2019 Feb 02]. Available from:
www.fda.gov/cder/regulatory/apploications/ind_page_1.htm.
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How to Cite
Kanti, S. P. Y., I. Csoka, A. Chandra, and V. K. Shukla. “Drug Approval Process in India and Europe”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 1, Mar. 2019, pp. 34-40, doi:10.22270/ijdra.v7i1.304.

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