A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE AND INDIA

  • Vishal Prajapati L.J. Institute of Pharmacy, S.G. Highway, Ahmedabad, Gujarat, India.
  • Rahulgiri Goswami L.J. Institute of Pharmacy, S.G. Highway, Ahmedabad, Gujarat, India.
  • Pratik Makvana L.J. Institute of Pharmacy, S.G. Highway, Ahmedabad, Gujarat, India.
  • Jitendra Kumar Badjatya Montajat Pharmaceuticals Co. Ltd., Dammam, KSA

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.
 

Keywords: MAA, USFDA, Drug approval, Clinical trial.

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Author Biographies

Vishal Prajapati, L.J. Institute of Pharmacy, S.G. Highway, Ahmedabad, Gujarat, India.

L.J. Institute of Pharmacy, S.G. Highway, Ahmedabad, Gujarat, India.

Rahulgiri Goswami, L.J. Institute of Pharmacy, S.G. Highway, Ahmedabad, Gujarat, India.

L.J. Institute of Pharmacy, S.G. Highway, Ahmedabad, Gujarat, India.

Pratik Makvana, L.J. Institute of Pharmacy, S.G. Highway, Ahmedabad, Gujarat, India.

L.J. Institute of Pharmacy, S.G. Highway, Ahmedabad, Gujarat, India.

Jitendra Kumar Badjatya, Montajat Pharmaceuticals Co. Ltd., Dammam, KSA

Montajat Pharmaceuticals Co. Ltd., Dammam, KSA

References

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How to Cite
Prajapati, V., R. Goswami, P. Makvana, and J. K. Badjatya. “A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE AND INDIA”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 1, Mar. 2014, pp. 1-11, doi:10.22270/ijdra.v2i1.7.