Publications by authors named "Nobumasa Nakashima"

Introduction: Responding to new threats and public health emergencies (PHE) creates serious challenges to regulators. The pandemic due to SARS-CoV-2 has been the catalyzer for change in global and local regulatory practices. Intensified collaboration, rapid and coordinated actions, and reliance mechanisms were key elements of the regulators' response to COVID-19 for all regulatory functions.

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Purpose: Regulatory convergence and cooperation among medical product regulatory authorities are essential to delivering safe and efficacious products quickly to patients. The COVID-19 pandemic highlights the urgent need for streamlined regulatory approval processes-which can be achieved in part through regulatory convergence and cooperation-both to accelerate availability of COVID-19 vaccines, treatments and diagnostics and to maintain the availability of the existing medical products unrelated to COVID-19.

Methods: The Asia-Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF) established the Regulatory Harmonization Steering Committee (RHSC) in 2008 to advance regulatory convergence among APEC's 21 member economies.

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: A survey was conducted among national regulatory authorities' members of the International Pharmaceutical Regulators Programme (IPRP) to collect and share experiences of reliance approaches. Reliance allows formally, or informally, one regulatory authority to use assessments made by other regulatory authorities while remaining responsible for the final decision. Reliance is an essential concept to increase the efficiency of the global regulatory oversight of medical products by national regulatory authorities.

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There are various kinds of good laboratory practice (GLP) monitoring authorities (MAs) in the world. Some countries have only one MA, while others, including Japan, have more than one MA. In addition, each MA has its own relationship with regulatory authorities (RAs), receiving authorities (RcAs) and industry based on the internal regulatory systems.

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