Comparison of CTD Modules with Southeast Asian Countries

Abstract

Southeast Asia, with its fast-growing, young population and uninsured majority represent a great opportunity for generics in the pharmaceutical industry. Although the generic market is currently quite small, improved access to medicines in the region means that it is growing rapidly and is expected to reach US$3.9 billion by 2016. This fact is expected to both intensify competition and attract multinational pharma companies to the area  Bigger markets in the region with low access to medicines, such as Indonesia, will drive the need for operational efficiency due to the increasing number of players, which is expected to drive down prices. In fact, Indonesia already introduced compulsory prescribing of generics in 2010 and plans to implement universal healthcare coverage by 2014.The transition from under developed nations to developing and now emerging markets has brought with it many conundrums and many opportunities. The ASEAN pharmaceutical market is relatively small but the region remains attractive due to the predicted double digit growth potential in future. The economic situation & health expenditure vary from one country to another country. Most of population in these low income countries like Philippines, Indonesia & Thailand depend on generic drugs. ASEAN Standards Bodies and Regulatory Authorities have been working closely with private sectors to address these technical barriers. None of the above achievements can happen without regional cooperation and strong collaboration of stakeholders. Moreover, regional cooperation on standards and conformance compels standards officers, regulators as well as industry to meet frequently and network effectively. The focus is on countries like Indonesia and Thailand is because of high population rate, maximum share of ASEAN pharmaceutical market, low income. But these countries are ranked after Vietnam and Philippines because of some restriction by countries government for foreign players. Singapore and Malaysia are the only countries in ASEAN, who have well established pharmaceutical regulations and more strict to quality & safety of drugs.