Abstract

CURRENT TRENDS IN DRUG PRODUCT REGISTRATION DOCUMENTATION AND HIGHLIGHTING OF LEGISLATED REGULATORY GUIDELINES

Eknath Babu T. B.*, K. Harikishan, T. Vamsi Krishna, M. Pratap Reddy, N. Vivek Reddy

ABSTRACT

Regulatory affairs profession is the bridge between pharmaceutical industries and regulatory bodies across world. It is mainly involved in registration of drug products in respective countries prior to marketing. In current circumstances pharmaceutical drug products registration and marketing going to stringent in various semi-regulated and regulated countries including India. Therefore US market is very stringent regulated market; this regulatory body of USFDA announces registration pertaining documents submitted to in a manner of eCTD format only regarding approval in US country and same as followed Europe union region countries like United Kingdom, Germany, and Italy etc. Currently regulatory legislation is submission management and publishing part is necessary in eCTD Tool utilization in respective versions. Some of Europe Union regulatory bodies followed by NeES format of submission for pharmaceutical drug product registration prior to marketing like TGA of Australia. Semi regulated countries drug regulated authorities wants submitted in ACTD or CTD format. Dossier preparation of all regulated and semi regulated countries as per ICH prescribed guidelines of M4.

Keywords: Regulatory affairs, eCTD, NeES, ACTD, CTD.