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Bio Technology : October 2009
Volume 19 • Number 3 • October 2009 Australasian BioTechnology 27 AusBioFEATURE --- AusBiotech 2009 the region, more than 60 percent of the world's population lives in Asia. This presents a significant catchment area to recruit prospective patients. These patients are frequently treatment-naïve or previously untreated, which presents a greater opportunity for study compliance and results in low patient drop-out. Due to fast-growing middle class and urbanisation in some of the markets, there is an emergence of 'westernised' lifestyles and the associated chronic diseases. The prevalence of these diseases facilitates the conduct of clinical studies in AP for the purpose of other regions such as North America and Europe. There are ample supplies of talented health care professionals in AP. China, for example has more than 100 medical schools with more than 200,000 medical graduates each year. This may not account for experience, but it is believed there are many experienced clinicians and drug development professionals of Asian origin currently in North America, Europe and Australia who are considering opportunities to return to their country of origin. Many governments in Asia are actively encouraging these professionals to return, and career opportunities are available from North American, European multinational companies reorganised to better serve the region itself. The rise of Asian multinationals such as Ranbaxy and Cipla, present another incentive. Regulatory drivers Following ICH's GCP guidance, many national agencies have issued guidance and aligned principles accordingly. Quality is recognised as a key element of the guidance and many governments have made significant investments, such as clinical research centres within major hospitals. As a measure of the quality, the US FDA Center for Drug Evaluation (CDE) and Research, Division of Scientific Investigations database showed (as of January 2008) there were a total of 48 clinical inspections with significant numbers in countries including Australia, China, India and Hong Kong. Of the 48 inspections, 17 were classified as 'No Action Indicated', 31 were 'Voluntary Action Indicated' and there were no inspections resulting in 'Official Action Indicated'. It is apparent the quality of drug development in AP is acceptable and comparable to that of North America and Europe. Key markets, such as India, have adopted the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). The agreement sets down minimum standards for many forms of intellectual property regulation and an acceptable level of assurance for drug development on proprietary information. Challenges in key regulatory markets There is strong support from many governments in the region to encourage global drug development activities. Regulatory assessment timelines for CTAs are considered crucial and countries such as Korea and Taiwan have streamlined processes to improve efficiency and maintain quality. However, these initiatives are not consistent throughout the region, for example, the regulatory assessment process in China remains lengthy compared to world standards. While approval times in China continue to be long, efficiencies are being introduced and new procedures, such as 'open door' every Wednesday at the CDE is encouraging sponsor interaction. Additionally, individual regulatory requirements such as local translations are obligatory in some countries. This results in a lack of a regional harmonised clinical trial approval process at the current time. In recognising this issue, collaborations such as the Association of Southeast Asian Nations (ASEAN) has set a charter to progress harmonisation, with similarities to the to the evolution of the European Medicines Agency. Success in emerging markets So how would one overcome the regulatory challenges to tap into the significant potential of an AP lead for a clinical development program? A strategic alliance with partners who have regional experience can maximise efficiency. Such partners can understand the objectives of the program and deliver clear strategies to negotiate issues. They understand not only local regulations and their interpretation, but how best to work with the bureaucracy as well as the crucial element of language and culture. The economic, geographical and clinical development environment offer an attractive proposition for companies wishing to conduct early-phase trials for global regulatory submissions. However, regulatory challenges and lack of harmonisation remain within some of the key regulatory markets. Overcoming the challenges requires on-the-ground experience to know how to manage the local regulatory requirements effectively and maximise efficiency. On- the-ground experts can provide this interpretation of the requirements which can alter approval times by months. In the future, we expect to see significant progress towards regulatory harmonisation and free trade.