COMPARATIVE STUDY FOR GENERIC DRUG APPROVAL PROCESS AND THEIR REGISTRATION AS PER CTD IN EUROPE, USA AND BRAZIL

  • Lincy Joseph Pushpagiri College of Pharmacy, Perumthuruthy P O, Tiruvalla, Kerala, India-689 107.
  • Mathew George Pushpagiri College of Pharmacy, Perumthuruthy P O, Tiruvalla, Kerala, India-689 107.
  • Kalpesh K Malaviya Pushpagiri College of Pharmacy, Perumthuruthy P O, Tiruvalla, Kerala, India-689 107.
  • Kalpesh K Malaviya Pushpagiri College of Pharmacy, Perumthuruthy P O, Tiruvalla, Kerala, India-689 107.
  • Bincy K Chacko Pushpagiri College of Pharmacy, Perumthuruthy P O, Tiruvalla, Kerala, India-689 107.
  • Jitendra Kumar Badjatya Montajat Pharmaceuticals Co. Ltd, Dammam, KSA.

Abstract

This aims to compare the generic drug approval and registration process in the regulatory market of Europe, USA and
Brazil. Based on the information collected from various sources such as regulatory sites, Government websites,
discussion with regulatory agent, interviewing pharma professionals and literature survey from various journals, a
clear picture on the generic drug approval and registration process of each country was drawn. The different
authorities’ viz. European Medicines Evaluation Agency (EMEA) of Europe, Food Drug Administration (FDA) of
USA and National Health Surveillance Agency (ANVISA) of Brazil carried out the generic drug approval and
registration process in the respective countries. After analysing the various requirements for the generic drug approval
in the above stated countries, it was concluded that the regulatory guidelines of Europe and Brazil was not well
defined. But FDA gives very much well defined requirements.
 

Keywords: Generic drug approval, EMEA, FDA, ANVISA.

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Author Biographies

Lincy Joseph, Pushpagiri College of Pharmacy, Perumthuruthy P O, Tiruvalla, Kerala, India-689 107.


Pushpagiri College of Pharmacy, Perumthuruthy P O, Tiruvalla, Kerala, India-689 107.

Mathew George, Pushpagiri College of Pharmacy, Perumthuruthy P O, Tiruvalla, Kerala, India-689 107.


Pushpagiri College of Pharmacy, Perumthuruthy P O, Tiruvalla, Kerala, India-689 107.

Kalpesh K Malaviya, Pushpagiri College of Pharmacy, Perumthuruthy P O, Tiruvalla, Kerala, India-689 107.

Pushpagiri College of Pharmacy, Perumthuruthy P O, Tiruvalla, Kerala, India-689 107.

Kalpesh K Malaviya, Pushpagiri College of Pharmacy, Perumthuruthy P O, Tiruvalla, Kerala, India-689 107.

Pushpagiri College of Pharmacy, Perumthuruthy P O, Tiruvalla, Kerala, India-689 107.

Bincy K Chacko, Pushpagiri College of Pharmacy, Perumthuruthy P O, Tiruvalla, Kerala, India-689 107.

Pushpagiri College of Pharmacy, Perumthuruthy P O, Tiruvalla, Kerala, India-689 107.

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

Montajat Pharmaceuticals Co. Ltd, Dammam, KSA.

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How to Cite
Joseph, L., M. George, K. K. Malaviya, K. K. Malaviya, B. K. Chacko, and J. K. Badjatya. “COMPARATIVE STUDY FOR GENERIC DRUG APPROVAL PROCESS AND THEIR REGISTRATION AS PER CTD IN EUROPE, USA AND BRAZIL”. International Journal of Drug Regulatory Affairs, Vol. 4, no. 2, June 2016, pp. 1-9, doi:10.22270/ijdra.v4i2.14.