Abstract

OVERVIEW ON REGULATORY FRAMEWORK FOR CELLULAR, TISSUE AND GENE PRODUCTS IN EUROPE, US AND JAPAN

Aakashdeep Raval and Dr. Dilip Maheshwari*

ABSTRACT

Purpose: In this modern era, diseases are developing in complex way and thus advanced therapies are essential to cure and prevent the diseases presently a day, because of nonexclusive rivalries and numerous issues center of pharma organizations has changed towards biological products, personalised medicines, targeted drugs especially cellular products, gene products and tissue engineered products. They are also known as advanced therapy medicinal products (ATMPs) or regenerative medicines. Method: Regenerative medicines are used to treat various diseases such as Alzheimer’s disease, Arthritis, Parkinson’s disease, nerve degeneration, cancers. They primarily derived from Biological creatures, animal tissues or modified human tissues. They may be of patients own cell or tissue or may be of diverse benefactors. So they are differing in their adverse reactions and their characteristics. They are not chemically synthesised molecule so regulations and quality controls tests for conventional medicines are not pertinent to them. Each nation has its own regulations of biologics in their own particular way as per their requirements. Mainly developed Countries designed regulations for their own country. Since it is extremely late strategy, harmonization for these regulations between all these nations has not been established yet. EMA, FDA and PMDA regulate these products respectively in EU, US and Japan. So database from their respective websites are used for this article. Result and Conclusion: This article will give overview of regulations and regulatory authorities, review committees and their regulatory framework for cellular, tissue and gene products in Europe, US and Japan.

Keywords: Regulatory Framework, ATMP, HCT/Ps, Regenerative Medicines, Cellular Products, Gene Therapy, Tissue Engineered Products.