Generic drug regulatory approval process in the USA, Europe, and India.

Regulatory involvement in the generic drug development hastens the drug approval process which directly/indirectly accelerated the launching of drug into the market. The regulatory documents whether in-house of documents to be submitted to regulatory authorities should be carefully reviewed by the skilled personnel to minimize the queries raised by the regulatory agencies and speed up the approval process. These are few differences in the dossier submission requirements among the three regions, i.e., the USA, Europe, and India which has been clearly represented through succinct comparisons third part of this work. Generic manufacturers may file an abbreviated new drug application that incorporates the safety/effectiveness data submitted by original innovator drug manufacturer and adds only bioequivalence studies. Therefore, it is very difficult and challenging task to approve a drug by the manufacturing companies, simultaneously submitted in all the regulatory authorities. The literature work, the comparison parameters, and difference in generic drug approval requirements have been delineated in this work, which gives clear depict where India lies in its generic drug approval process and the challenges that Indian regulatory authority has to overcome in the near future. [ABSTRACT FROM AUTHOR]