• Brinda Ashishkumar Tailor
• Dr. Vineet C. Jain

A generic drug is more efficient, safe, and low cost alternative of the innovator or branded drug in the market. Generic drugs are marketed after the expiry of the patented drugs. ICH process Common Technical Document (CTD) has been developed for standardized structure for regulatory submission that is acceptable in all ICH countries. There are few differences in the dossier submission for various regions. Aim of this study is to understand the current generic drug registration requirements and approval process in the regulatory market of USA and EU. Abbreviated New Drug Application (ANDA) can be filed to the regulatory authorities, to get generic drug approval. Under section 505(j) of Hatch-Waxman Act, ANDA may be filed for any generic version of the reference listed drug where as generic drugs in EU approved under the marketing authorization. After analysing the various requirements for the generic drug approval in the above stated countries, it was concluded that the regulatory guidelines of Europe was not well defined but FDA gives very much well defined requirements.

Generic Drug, USA, ICH, ANDA, Generic Drug Approval

"Current Status of Generic Drug Approval Process in USA and EU", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.6, Issue 4, page no.569-581, April-2019, Available :http://www.jetir.org/papers/JETIR1904A84.pdf

"Current Status of Generic Drug Approval Process in USA and EU", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.6, Issue 4, page no. pp569-581, April-2019, Available at : http://www.jetir.org/papers/JETIR1904A84.pdf