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Specialized Reviews for Clinical Research Projects Involving Investigational New Drugs

  • Data Source:Food and Drug Administration, Ministry of Health and Welfare
  • Created:2017-12-12
  • Last Updated:2017-12-20

On December 12, the Ministry of Health and Welfare (MOHW) enacted an amendment to Article 55-1 of the Enforcement Rules of the Medical Care Act, in response to the international trends in regulating human research involving investigational new drugs and for the purpose of enhancing specialization and hierarchical management. As stipulated in Article 78 of the Medical Care Act, verification and approval of human research projects involving investigational new drugs may be done by means of appointment or authorization, if necessary, in order to protect the rights and interests of human subjects and improve the international competitiveness of domestic human research projects.

Article 78 of the Medical Care Act provides that any change in a human research project or its contents shall be made only upon verification or approval by the central competent authority and the Institutional Review Board. As the global biotechnology industry is blooming, the MOHW is endeavoring to promote the rapid development of medical and pharmaceutical services in Taiwan. Moreover, considering the rights and interests of human subjects and the international trends in regulating human research involving investigational new drugs, the MOHW aims to implement a specialization program that enables professionals to conduct reviews based on their scientific knowledge and technical experience in their specialized area, as well as to establish various management systems according to the complexity of different cases. Thus, the amendment to Article 55-1 of the Enforcement Rules of the Medical Care Act has been proposed.

The purpose of this amendment is to provide a legislative basis that allows the verification and approval of human research projects involving investigational new drugs to be done by appointing affiliated agencies or authorizing other institutions or corporations to do so when necessary. Hierarchical management will be implemented on human research projects involving investigational new drugs and related change proposals based on their risk level . Low-risk cases will be given priority for review by other institutions or corporations upon authorization. Focus will also be placed on prevention of repeated reviews and acceleration of the human research process to achieve the desired outcomes after lifting government regulations. In the meantime, the MOHW will put more effort into monitoring the management and reporting systems, so as to provide a high quality environment for human research in Taiwan and protect the safety and rights of human subjects.