General Review of Clinical Trial Environment in Japan 2014

Research and Markets (http://www.researchandmarkets.com/research/7wz5xs/general_review_of) has announced the addition of the "General Review of Clinical Trial Environment in Japan 2014" report to their offering. (Logo: http://photos.prnewswire.com/prnh/20130307/600769 ) In Japan, companies begin researching and developing pharmaceutical products by looking at novel compounds that show promising activity. Then - once they have determined the effectiveness, properties, movement within the body, and toxicity of certain compounds through non-clinical trials - the researchers can progress to human subjects in clinical trials. The results are submitted to the Minister of Health, Labour, and Welfare for approval, and if the product is approved, it can be commercialized. There are a variety of tasks that exist when implementing clinical trials, and typically these tasks are carried out by an expert from each relevant field. Pharmaceutical companies traditionally used in-house resources to carry out R&D tasks, but what originally became popular mainly among foreign companies, the outsourcing of such tasks to CRO and other such organizations, has now begun to take hold among domestic companies as well. For quite a while, and until recently, the number of clinical trials within Japan had stagnated, but this trend has begun to be reversed as government initiatives, beginning in 2003, to improve the clinical trial environment for multinational studies has been successful. A number of issues affecting the clinical trial environment within Japan have been indicated previously, including that trials take too long, that the quality is poor, and that they are too costly. In order to achieve a breakthrough in this situation, the government (MEXT and MHLW) created the 'National Clinical Trial Revitalization Plan' in April of 2003. In addition, striving to further improve the clinical trial environment in Japan, they created the 'New 5-year Clinical Trial Revitalization Plan' in March of 2007. There has been a certain amount of success based on these initiatives, including an increasing trend in multinational studies, but improvements in study environments in Asian countries such as China and Korea have been progressing at a speed greater than in Japan, and speaking from a global perspective, it is hard to say that the environment for clinical trials in Japan has been greatly improved. This report talks about the overview of the environment surrounding clinical trials in Japan. As the local professionals have conducted on-the ground research as well as academic research, readers will see what is really going on in Japan. The report also touches some information about other Asian countries such as Korea, China and Taiwan, readers will be able to see overall trend in Asian region.

Key Topics Covered: I. Summary II. Pharmaceutical R&D Flow III. Definition of Clinical Trial IV. Main Tasks involved in Clinical Trials V. Laws and Regulations relating to Clinical Development VI. Outsourcing to External Organizations VII. Shift in the Number of Clinical Trials VIII. Issues IX. Future Outlook For more information visit http://www.researchandmarkets.com/research/7wz5xs/general_review_of

Media Contact: Laura Wood , +353-1-481-1716, [email protected]

SOURCE Research and Markets

Latest Press Release on Corporate News

KPJ Pasir Gudang Specialist Hospital Partners with NetSfere for Secure and Compliant Messaging

CHICAGO, March 26, 2024 (GLOBE NEWSWIRE) -- NetSfere , a global provider of next-generation secure and compliant messaging and mobility solutions, today announces that KPJ Pasir Gud...

Philips convenes the Annual General Meeting of Shareholders 2024

March 22, 2024 Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), today announced it has convened the Annual General Meeting of Shareholders (AGM) 2024 and pu...

Amlan International Forges Strategic Partnership with Grupo Profil as its Newest Latin American Distributor, Amplifying Access to Innovative Gut Health Solutions for Protein Producers

CHICAGO, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Amlan ® International, the animal health division of Oil-Dri ® Corporation of America, is excited to announce its partnership with Grupo P...

Impulse Dynamics Completes $136M Financing Round

Marlton, NJ, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure (HF), is proud to an...

Global Healthcare E-commerce Market to Accrue $1038.17 Billion by 2030, Registering a Robust 19.93% CAGR, Propelled by Rising Adoption of Online Healthcare Solutions, States Kings Research

DUBAI , UAE , Feb. 13, 2024 /PRNewswire/ -- According to a recent Kings Research study, the global Healthcare E-c ommerce Market was valued at USD 244.99 billion in 2022...