Drug Product Registration in Semi-Regulated Market

Abstract

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.

Comparative study of Regulatory requirements of Drug Product in Emerging market

“…These countries are differing in their region and also in many other aspects as regulation of Pharmaceuticals, Using different Guidelines for registration, registration fees, Requirements to maintain registration, duration of registration Patent regulation and legislation for the drug. (1) The Asia Pacific market is expected to grow from USD 187 billion in 2009 to nearly USD 275 billion in 2013 and has developed to a great extend till date, at a CAGR of more than 13%. The main reason behind this is, due to low cost availability of generic medicines, rising income, growth of business and health insurance schemes.…”

“…The main reason behind this is, due to low cost availability of generic medicines, rising income, growth of business and health insurance schemes. (1) The optimization in requirements is mandatory and can be judged by the incidence of higher cost involved in availability of drugs, research and development facilities. For better treatment safety and efficacy for the drugs must be justified and rationalize for public security.…”

“…The Systematic formulation development acts as a back bone for any dossier preparation in export registration. (1) The Registration requirement are different for different countries so it is difficult for any company to develop product for each region Therefore; we need to consider majority of requirements during technical data submission which will help in export registration therefore, harmonisation occurs as clusters in Emerging markets are necessary for submission of dossier eg.…”

“…ASEAN Countries such as Thailand, Singapore and Vietnam have harmonisation. (1) Asia is expected to overtake Europe in pharmaceutical market within the next decade and sales are driven by growth in key emerging markets. e.g., China is deemed to be the largest pharmaceutical market after the United States by 2020.More than 85% population lives in the emerging market and so the real economic growth has come from these markets.…”

“…This promotes many MNC's switched to these emerging countries particularly in China, India, Russia, Korea, Saudi and Mexico. (1) The growth is increasingly moving beyond the use of CRO's and marketing of well-established products to include early-stage research and technology aimed at e-ISSN: 2321-6794…”