Voicing regulatory perspectives of the combination products

Abstract

Combination products (CPs) are nothing but medical products that do not adequately apt solely into a regulatory category, but reasonably comprise of any combination of drug, device and biological product. The use of combination products and delivery systems are to deal with a chronic condition or to relieve an acute condition or to treat the various lives threaten & complex diseases. This article assesses the regulation of combination products in USA, India, China, Japan and Europe and likens the regulatory regime in pharmaceutical environments. Though many of these types of products have been available for years, recent FDA guidelines have spelled out viewpoint on both a development and commercialization perspective. These elucidations have led to augment regulatory expectations resulting in new and increased challenges. To make sure compliance with these regulations and beat challenges, it is essential to remain familiar with the dynamic changing regulations. This piece of writing spotlights on key aspects to understand the concept of combination products, its classification, review period and most importantly facts to consider when any organization is gearing up for a regulatory submission to regulatory agency and its prospective for PLCM of the combination product.