Pre-filled syringes in developed and developing region: An insight into Regulatory considerations

Abstract

A Pre-filled syringe is a disposable syringe that is supplied already loaded with the substance to be injected. It is a unit dose of parenteral medication to which a needle has been fixed by a producer. They are small which make them easy to carry and are dependable for delivering a precise dose of medication. These reasons are leading to growth of parenteral medication in pharmaceutical market. The intent of this review article is to provide information on regulatory guidelines involved in submission approach for marketing authorization of pre-filled syringe in developed region (USA, EU) and developing region (India). It also further explains about complexities associated with Pre-filled syringes in terms of regulations, submission approaches and quality development considerations in developing region. There is a need to develop an effective regulatory framework to make regulations of Pre-filled syringes more comprehensive for regulatory bodies. A harmonized forum to be made through which single application can be made and single review process can be followed to avoid deviations in regulatory pathways.