Open AccessDRUG PRODUCT REGISTRATION IN SEMI-REGULATED MARKET
Author(s) -
Jitendra Kumar Badjatya,
Ramesh Babu Bodla
Publication year - 2018
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v1i2.3
Subject(s) - business , authorization , marketing authorization , product (mathematics) , latin americans , quality (philosophy) , regulatory authority , international trade , finance , political science , public administration , computer security , bioinformatics , philosophy , geometry , mathematics , epistemology , computer science , law , biology
There found a diversity of regulatory requirement in Semi regulated market. This region consists of mainly thecountries from Asia pacific, Latin America, Eastern Europe, Africa and Gulf countries. Countries from Asia pacificand Gulf have somewhat harmonized their regulatory environment through The Association of Southeast AsianNations (ASEAN) and Gulf Co-operation Council (GCC) organizations, ROW countries yet to be harmonizedregulations in their respective regions.The urgent requirement to rationalize & harmonize regulation was required by instance of rising cost of health care,research & development and to meet the public requirement for safe and efficacious treatments to patient in need.ICH committee has given priority to harmonize the format of reporting data for quality, safety and Efficacy in theapplication dossier.The commercial significance of ROW markets is increasing globally. It is crucial that pharmaceutical companies keepup-to-date with the latest regulatory developments to ensure their place on the ROW market.This paper favors the regulatory processes for gaining marketing authorization in ROW countries in terms oftechnical data requirement for the dossier.