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


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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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.