Asuntos regulatorios farmacéuticos: acceso abierto

Comparison of registration requirement of generic drugs in USA, Canada & Europe with Zimbabwe


Patel Hetvi*, Shah Krutarth and Joshi Yash

Generic drug products played an important role in the health care system in global aspects especially in the middle income country and fully developed country. They play important role in the lowering the cost of medicine and provide the low cost treatment in targeted countries. Generic drugs have the same therapeutic value same as the innovator product. This study aims to achieve the comparison of the regulation of generic drug product regulation in Zimbabwe, USA, Canada and Europe. All of the targeted countries follows the common technical document format and also focuses on safety quality and efficacy of the drug product. Regulation of generic drug in Zimbabwe is easy compared to rest of the countries.

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