Medicines development in the Asia Pacific region

Victoria Elegant

Abstract

The Asia Pacific region is an extremely diverse region, characterized by heterogeneity from a number of aspects, including culture, religion, economics, landscapes, and languages. This also applies to the standard of medical care and the regulatory requirements for approval of drugs in the region. Developed economies such as Japan and Australia have requirements which are not dissimilar to those of the EU and USA, but still have their own unique requirements. The developing economies all have their own requirements. In the ASEAN region there is harmonization of the dossier format, but each country still has local requirements. The region has seen significant growth in clinical trial activity, both to satisfy local registration and safety requirements and to help accelerate global trial patient recruitment. There is a clear need for training in all aspects of medical, regulatory, clinical and safety aspects of medicines development, which is being addressed through several organizations and at different locations in the region.


Keywords

Asia Pacific; medicines development; drugs; biologics; clinical trial regulatory; safety; CPP; stability; ICH; dossier; ASEAN; CTD

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References

The World Bank, Overview, updated October 4, 2015, viewed June 15, 2016,

Chakma J, Sun G H, Steinberg J D, et al. 2014, Asia’s ascent—global trends in biomedical R&D expenditures. New England Journal of Medicine, vol.370(1): 3–6. http://dx.doi.org/10.1056/NEJMp1311068.

APFED, 2005, Overview of the Asia-Pacific Region, Asia-Pacific Forum for Environment and Development, viewed June 16, 2016,

U.S. National Institute of Health 2015, ClinicalTrials.gov, viewed June 2, 2016,

Health Sciences Authority 2016, Singapore Governments,

Central Drugs Standard Control Organization 2014, Ministry of Health and Family Welfare, Government of India, viewed June 1, 2016,

China Food and Drug Administration n.d., viewed June 17, 2016,

Ropes & Gray, 2015, China’s State Council announces reform on the drug and device approval system, viewed June 4, 2016,

Novartis boss says China will continue to outstrip Europe and US, 2016, Financial Times, viewed June 20, 2016,

Pharmaceuticals and Medical Devices and Agency, n.d., viewed June 5, 2016,

Lane E J, Big three Asia pharma markets poised to soar in 2015, Fierce Pharma, viewed June 16, 2016,

Food and Drug Administration, n.d., Ministry of Health and Welfare, Taiwan, viewed June 9, 2016,

Ang W Z 2015, Streamlined clinical trials regulations will boost pharmaceutical investment in Taiwan, BioSpectrum, viewed June 14, 2016,

Korea Food & Drug Administration, n.d., viewed June 3, 2016,

Samiya LK 2014, South Korea: sprinting clinical trial development, Clinical Leader, viewed June 13, 2016,

Chee D, Park M S and Sohn J-H, 2015, New initiatives for transforming clinical research in Korea. Journal of Medicines Development Sciences vol.1(2): 27–32. http://dx.doi.org/10.18063/JMDS.2015.02.003.

Therapeutic Goods Administration, n.d., Department of Health, Australian Government, viewed June 3, 2016,

Clinical Trials Capability Report, 2015, Australian Trade Commission, Australian Government, viewed June 19, 2016,

Delivering Reforms — Implementation plan for TGA Reforms: a blueprint for TGA’s future, 2012, Therapeutic Goods Administration, Department of Health, Australian Government, viewed June 18, 2016,

Australian Government Clinical Trials Initiatives, 2016, Australian Clinical Trials, Department of Industry, Innovation and Science, National Health and Medical Research Council, Australian Government, viewed May 28, 2016,

Biswas P, 2013, Pharmacovigilance in Asia, Journal of Pharmacology & Pharmacotherapeutics, vol.4(5): 7–19. http://dx.doi.org/10.4103%2F0976-500X.120941.

Handbook 2016 Postgraduate Coursework, Pharmaceutical Medicine — 9060, n.d., UNSW Australia, viewed June 7, 2016,

BMI Research, 2014, Industry trend analysis : 2014 outlook for the pharmaceutical industry in the Asia Pacific region — FEB 2014, viewed June 5, 2016,


DOI: http://dx.doi.org/10.18063/JMDS.2016.01.004
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