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The Asia Pacific (AP) region is diverse and dynamic. It comprises over 40 economies, with about 24 markets that are relatively more active in terms of promulgating and implementing regulations that impact the biopharmaceutical industry and advance drug development. Although many country- and territory-specific regulations, often driven by the local economy and market dynamics, exist, the overall trend in the AP region is toward international harmonization and global convergence. More markets are now participating in the International Council on Harmonization (ICH), and there is growing interest in identifying and incorporating best practices from competent regulatory agencies. These include expedited pathways to speed access to new medicines, and incentives and other means to encourage innovation. In this paper, we provide a summary of recent activities in select AP markets. [ABSTRACT FROM AUTHOR]

Abstract: Corporate social responsibility (CSR) is increasingly seen as an imperative for sustainable business and there is a growing literature on the effect of CSR on corporate reputation. Despite this, a pall of ambiguity and uncertainty remains around what CSR means and how it should be practiced. This paper offers a unique addition to the body of literature to date by revealing that CSR is an emerging industry in Australia, which is in the process of developing its own reputation as a set of business practices. The paper is based on exploratory qualitative research using a case study methodology. Interviews were conducted with key actors within the industry to investigate shared understandings of what CSR means, perceptions of CSR practice and of the industry as a whole, and who is involved in shaping these perceptions. The research revealed that the CSR industry in Australia is in its early stages of development and is therefore in need of increased internal cooperation if it is to develop a strong reputation. [Copyright &y& Elsevier]