Life science research and patents in Japan: a comparative study of life science invention patentability between the Japanese and US Patent Acts

Takenaka, Toshiko

doi:10.4337/9781783479450.00031

Cited by 1 publication

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“…Simultaneously, public health agendas were prioritised to ensure low-cost medication for the Japanese population. Researchers [27], [47], [48] state that stifled development in the Japanese pharmaceutical industry was the unintended result of Japan's protective governmental regulation of its pharmaceutical organisations, and that this compromised the ability of Japanese pharmaceutical manufacturers to compete with their western counterparts. International pressure through the ICH was a critical factor that eventually forced Japan to consider a more open approach to the pharmaceutical trade in the 1990s.…”

Section: Focus B: Rules and Regulations (N=26)mentioning

confidence: 99%

A Tale of Three Regions: Quality Culture and Its Impact on Pharmaceutical Production

Swartz¹,

Singh

2022

SAJIE

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This study presents a comparative literature examination of the pharmaceutical industry in Japan, Europe, and the United States, focusing on quality culture, which historically has impacted operations in these regions. It aims to highlight generic pitfalls that result from cultural influences so that these can be avoided when designing a conceptual model of quality management practices for South African organisations. Simultaneously, the literature illuminates areas where culture promotes operational excellence (OpEx) in production. Quadrants of the organisational cultural analysis instrument (OCAI) are used to collect and examine research data from 72 literature sources. An activity theory research approach is adopted to perform a comparative study to ensure a consistent formal examination of the three geographical regions. During this analysis, industry traits presumed to be supported by culture types are highlighted and examined. Findings from this examination will be used in a future study to develop an OpEx model for South Africa, based on quality culture. Keywords Pharmaceutical Manufacturing; Operational Excellence; Quality Culture

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Section: Focus B: Rules and Regulations (N=26)mentioning

confidence: 99%