Pharma Focus Asia
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Clinical Trials in Asia

Overcoming Regulatory Concerns

Prasanthi Potluri, Editor Pharma Focus Asia

Housing more than half the world\'s population, Asia is attracting more clinical trials with rapid patient recruitments. The three key clinical development regions in Asia-India, China and South East Asia-play a major role in global clinical trials. Cost savings with convenient and high performing sites available in these regions are attracting sponsors, thus increasing clinical trials activity.

Asia's clout in global clinical trials, with these growth regions, is expected to continue growing in the coming decade. Global CROs are expanding their presence in Asia in line with market growth.

Given this potential, the number of studies in the region has increased significantly and approvals have followed suit. According to the US government's global trials registry, clinical trials held in India in 2009 were 9.6 per cent lesser than the number of trials a year before, but the number increased by 15.3 per cent in China and by 20.7 per cent in Korea as against the previous year. In 2008, the number of new global studies approved rose to 200 in India and to more than 300 in China.

Concerns about protection of intellectual property (IP) in Asian countries are getting resolved due to international pressure and domestic economic development. Improving clinical trial approval timelines and streamlining regulatory processes in India and China augur well for Asian pharmaceutical industry.

The regulatory landscape is dotted by different regulators, making it important for companies to have different strategies for each country. Local regulatory authorities like China State Food and Drug Administration (SFDA), Ministry of Health and Family Welfare's Drugs Controller General of India, the Food Safety and Standards Authority of India, Pan American Health Organization (PAHO) and many other bodies enforce rules and regulations pertaining to clinical trials approval process.

In this issue of Pharma Focus Asia, Alistair Davidson an industry expert from PPD, UK shares his ideas about how Asia is becoming attractive for inclusion in global development programs and how to overcome regulatory barriers in Asia by harmonization of clinical trial regulatory strategies.

The issue includes other industry leaders' thoughts on interesting topics like Recent advances in analytical methodologies for the determination of impurities in drugs, overview of the recent FDA draft guidelines on Biosimilars, Compulsory Licensing, GCP

Author Bio

Prasanthi Potluri
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