GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by original innovator drug manufacturer and adds only bioequivalence studies. Therefore it is very difficult and challenging task to approve a drug by the manufacturing companies, simultaneously submitted in all the regulatory authorities. Regulatory authorities are responsible to ensure the quality, safety, and efficacy including manufacturing, distribution of the drug product. There is lot of challenges for the pharmaceutical industry to development and filling of generic drug application, which can be overcoming by the common format of submission. This is due to the different regulatory procedure of the various countries. Through the international conference on harmonization (ICH) process common technical documents (CTD) has been developed for USA, EU, JAPAN, INDIA AND CANADA. There are few differences in the dossier submission for among these five regions. To development of any generic drug product still we need strategic planning by these regulatory authorities. Keywords: Generic drug, Regulatory authority, Drug development, FDA, ANDA, ICH