Abstract

A REVIEW ON COMPARISON OF REGULATORY REQUIREMENTS TO APPROVED DRUG DEVICE COMBINATION PRODUCTS IN EUROPE AND USA

Narechania Siddharth N*, Trupesh Pethani, Dr. Navin.R.Sheth

ABSTRACT

Combination products means a combination of Medicinal drug or device or biologics which are used for the treatment and prevention of wide range of disorder and medical conditions because when they use alone can only slow down or stop the progression of disease or injury. In order to tackle the clinical problems of the future, these products will be combined these are emerging and Morden day techniques for the drug delivery products. This article highlights on the legal basis of the current regulation in the USA regarding drugs, biologics and medical devices in general and will discuss the regulatory processes involved in getting a combination product into the Food and Drug Administration (FDA) approval processes. The role of Each centers for the regulation of this products and Combination product regulation in Europe is in its infancy and USA combination legislation has yet to be realised in the European Directives. In this article, the basic building blocks for a regulatory strategy in Europe are presented,. Description of various guidelines required for the authorisation of Drug device combination products and their Different regulatory environments and various development requirements in EU and US. Requirement of common regulatory approach or strategy in future for these products, which would result in easier and coast effective procedures for the regulation of combination products in the lucrative market in US and EU.

Keywords: Combination products, Europe Union, United States, Regulations, Medical Device, Drug products