ASIAN JOURNAL OF PHARMACEUTICAL SCIENCES AND RESEARCH Procedure for Pharmaceutical Generic Dossier Filling of Solid Oral Dosage Forms for "ASEAN Countries" & A Comparative Study of ASEAN CTD & ICH - CTD

The ASEAN pharmaceutical market has experienced strong growth and a rise in the regional standard of living which have made it a region of interest for companies looking to explore new business opportunities. The ASEAN Pharmaceutical market represents huge potential for companies looking to expand operations. Notably, there is strong interest in R&D for generics in this region, which are expected to grow from 8.3% of the total market in 2010 to 12.8% by 2015, when they will be worth USD 12.3bn. Within the next decade, Asia is expected to overtake Europe in pharmaceutical sales, driven by growth in key emerging markets Eighty-five percent of the world's population lives in the emerging markets, and during the past 5 years, all real economic growth has come from these markets. Some observations help to explain why many large pharmaceutical companies have increased their presence in emerging markets in recent years — in particular in ASIA. Notably, this growing presence is increasingly moving beyond the use of contract research organizations and marketing of established products to include early-stage research aimed at specific medical needs of patients in these regions.