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 second largest pharmaceutical market after the United States by 2015. 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,

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.

The urgent requirement to rationalize and harmonize regulation was impelled by instance of rising cost of Healthcare, Research and Development and need to meet the public requirement to approach for the safe and efficacioustreatments 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.ICH also provides different Guidelines under the topic Quality, Safety, Efficacy and Multidisciplinary to control thequality safety and efficacy of Pharmaceutical and Biotechnological products.For the dossier application part CTD provides harmonized format for product application. Earlier all the submissionssent to regulatory authorities in CTD, Paper format but it was a tedious job requiring lot of Time to review,documentation and paper work.Due to the advancement in Information technology, regulatory authorities from regulated countries throughout theglobe started to accept data in electronic format either in eCTD (Electronic common technical document)/ NeeS (NoneCTD electronic submission).The eCTD was developed subsequently by the ICH M2 Expert working group and allows for the electronicsubmission of the CTD from the applicant to regulator and provides harmonized technical solution for CTDelectronically. Many regulatory authorities completely eliminated the Paper submission and made eCTD mandatory.This is the centralized approach, saves time, cost, facilitate review process and greater transparency can be achievedvia central processing of submissions.Harmonization can also be seen in IPR stream by treaties and conventions. These international treaties andconventions contribute to the process of harmonization of patent laws.

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Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exist in clusters with their mutual concern. The optimization and harmonization requirements has become mandatory and can be examined by the incidence of higher cost involved in availability of drugs, quality requirement of premise and research and development, regional registration requirements. Quality, Safety and Efficacy data has significance importance in dossier registration. Pharmaceutical Industries has to comply with regulatory requirement in Emerging market and for betterment of public Health and safety. The review also explains a brief about different regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier application in Emerging market.