Comparative Study of Regulation and Registration Process of Parenteral Product in US and Malaysia

Author(s)

Bhargava, N.S., Shah, D.B., Maheshwari, D.G.

Author's Affiliation

Abstract

Requirement of drug registration of every country is different so it is difficult to get global marketing approval at same time and launch product at once in all regions. So one has to understand strategy of all regions by looking at target region, patent terms, data requirement timelines for launching product in different regions. Parenteral product provides maximum bioavailability and efficacy than the oral dosage form due to which the demand for parenteral preparation increases day by day. So it has stringent regulation in many countries. Parenteral products if not sterile, non-pyrogenic can cause severe harm to health causing life-threatening risk to patient. So its regulation is necessary. The study of the differences and similarities will help to find methods for global harmonization, which is currently a vital need for Pharmaceutical Regulation. Regulatory point of view this kind of evaluation will help the newly developing industry for better understanding of requirements, process and timeline for registration, so based upon better understanding they can plan good strategy to get best outcomes within short time.

Keywords

Parenterals, Regulation of Parenterals, Administrative and Prescribing Information

Cite This Article

Bhargava, N.S., Shah, D.B., Maheshwari, D.G. (2015). Comparative Study of Regulation and Registration Process of Parenteral Product in US and Malaysia, International Journal for Pharmaceutical Research Scholars (IJPRS), 4(1), 74-81.