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Quarterly Issue Sep 2009 NO.03


LATEST LEGAL NEWS



THE TAIWAN FOOD AND DRUG ADMINISTRATION WILL BE ESTABLISHED



The Legislative Yuan, after the third reading on May 12, 2009 has passed the "Organization Rules of the Food and Drug Administration," for the purposes of strengthening the surveillance of the food and drug as well as coordinating authorities and executive capability, cooperating with the policy of biotechnology and pharmaceutical industry development, enlarging the examination and research quality, and concerning about citizen´s health and consumer´s rights. After, announcement of the "Taiwan biotechnology action plan" by Executive Yuan on March 26, 2009.....[more]




EXECUTIVE YUAN HAS TRIED TO BOTH MAINTAIN PRIVACY AND IMPROVE MEDICINE INDUSTRIES BY REGULATING BIOBANKS



Medical research has demonstrated that a disease does not always arise from a single gene defect, but that multiple gene and environmental factors play major roles. Therefore, to develop medical prevention strategies and therapeutic drugs cure, many countries have established Biobanks to collect human biologic specimens for research. In Taiwan, Executive Yuan also approved draft "Act on Biobanks" on July 2009 to regulate the establishment and administration of Biobanks and to protect participants....[more]




THE GOVERNMENT PLANED TO PROMOTE THE NEW ENERGY INDUSTRY BY SUBSIDIZATION AND EXEMPTION OF COMMODITY TAX



To strengthen the capacity of green energy industry, in April 2009, the Executive Yuan has particularly integrated the "Green Energy Fields" into the six emerging industries which were focused by the government for developing national economy.....[more]




TAIWAN GOVERNMENT HAS MODIFIES RULES TO ACCELERATE NDA PROCESS AND FACILITATE DEVELOPMENT OF CLINICAL STUDIES IN TAIWAN



In July 2007, the "Biotech and New Pharmaceutical Development Act" modified many regulations related to pharmaceutical administration, taxes, and professionals in Taiwan. In addition, in order to facilitate the development of the biotechnology and pharmaceutical industries, the government has attempted to create a friendly environment for research and development by setting up appropriate regulations and application systems....[more]




INDUSTRIAL TECHNOLOGY STRATEGY REVIEW BOARD CONFERENCE FOR INFORMATION SECURITY STARTED ON THE 18TH OF AUGUST



In order to accelerate the development of electronic information and biotechnology industry, Executive Yuan has separately held the Strategy Review Board Conference for each industry since 1992 and 1997. With the discussion made by the two conferences, our government would integrate the conclusions as an important concept for promoting industrial technology policies....[more]




DOH REVISED THE REGULATION FOR PRODUCTION AND MANAGEMENT OF EMR



To reduce practical errors and improve efficiency of medical service, the Department of Health (DOH) has been actively encouraging and promoting the implementation of electronic medical records (EMR) at hospitals and medical institutes. The all-around implementation of EMR is expected to be accomplished in 5 years(by 2014), as well as the complete establishment of EMR exchange system. In the legislation aspect, the DOH has proceeded to amend the relevant laws and regulations in recent years....[more]



RECENT DEVELOPMENTS


ISSUES RELATING TO THE PROMOTION SYSTEM AND LEGAL FRAMEWORK OF CULTURAL AND CREATIVE INDUSTRIES



Aiming to encourage the development of cultural and creative industries, a draft Act on the Promotion of Cultural and Creative Industries was promoted by our government since 2003. During the process of legislation, issues regarding to the bill have been argued by different groups...[more]




THE RESEARCH IN NORMS OF INDUSTRY SELF- REGULATION IN NANOTECHNOLOGY-- NANOTECHNOLOGY INSURANCE MECHANISM AND VOLUNTARY REPORTING PROGRAM IN THE UNITED STATES



In recent years the rise of nanotechnology research and development to make use of the progress of many revolutionary innovations in many industries. While the nanotechnology industry for innovation and business opportunities brought about, but also for the relative health of human society and the environment of health system hazards, lead to many doubts about the potential risks...[more]




ON THE COPYRIGHT ISSUES RELATED TO DRUG LABELLING–A PERSPECTIVE FROM THE EU



In the past few years, Taiwan generic drug companies are sued for copyright infringement of drug labeling by representatives of foreign drug companies. Key disputant points in these cases are as followsOn one hand, Taiwan Copyright Act provides that a work with the lawful copyright protection whenever it meets the "originality" requirement...[more]




A STUDY ON CONTRACT PERFORMANCE GUARANTEES-TO BEGIN WITH R&D PROGRAM SUBSIDY CONTRACT



To encourage Technology R & D, Ministry of Economic Affairs conducts business subsidy according to Article 22-1, Section 2 of Statute for Upgrading Industries and forms subsidy contracts with businesses which accept subsidy...[more]



LEGAL STUDY ON REGULATIONS RELATED TO CERTIFICATE AUTHORITY MANAGEMENT AT JAPAN AND KOREA – WITH THE RESPECT OF TAIWAN ELECTRONIC SIGNATURE LAW AND ITS FUTURE DEVELOPMENT



The civilization of human society closely correlates with the record and the transferring mode of information. Along with the development of internet and digital technology, traditional handwritten signature and seal are replacing by electronic signature, which make the ensuring of the truth of electronic document and other electronic messages to be possible...[more]




THE REVENUE SHARING SYSTEM OF GOVERMENT -SPONSORED RESEARCH IN TAIWAN AND THE UNITED STATES



Research and development (R&D) in which a lot of funds are invested by governments are usually considered as an essential part to the economics growth of a country. However, how the investments can be measured and how the governments can be benefited from R&D funding become a continuingly arguable issue...[more]



 
 

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