Suchergebnisse

Product registration in rest of world is a challenging task like regulated countries (US, EU & Japan) as they are not harmonized. It creates a difference in regulatory environment in Semi Regulated countries. Enormous diversity of regulatory requirements are found in this area. This region consists of mainly the countries from Asia pacific, Latin America, Eastern Europe, Africa and Gulf countries. Countries from Asia pacific and Gulf have somewhat harmonized their regulatory environment through The Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) organizations, ROW countries yet to be harmonized regulations 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 the application dossier. The commercial significance of ROW markets is increasing globally. It is crucial that pharmaceutical companies keep up-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 of technical data requirement for the dossier. Keywords: ROW, ASEAN, GCC, BMR, CIS, DMF, TSE/BSE, ICH, FP