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Enhancement measures for clinical trial protocol review process 【Date:2017-10-19】 unit:藥品組


    Taiwan Food and Drug Administration (TFDA) announced theEnhancement measures for clinical trial protocol review processto help accelerate new drug development, make patients get early access to innovative medicines, on Aug 10, 2017, as well as to facilitate Taiwan’s development on biotechnology and pharmaceutical industries.

     The announcement consists of three specific enhancement measures, including establishing cell therapy/gene therapy clinical trials fast-track review mechanism, streamlining first in human trials review process, and refining the review process of clinical trial protocol amendments based on the degree of changes.

    These enhancement measures are not only to streamline the clinical trial protocol review process, but also to optimize the technical review manpower by risk management of the applications. When taking the clinical trial safety and scientific standard into consideration, these enhancement measures to reduce clinical trial protocol review time period and improve review efficiency would be beneficial to upgrade Taiwan’s global capacity and competiveness of clinical trials. In addition, a new 30-day clinical trials fast-track review mechanism was established for those cell therapy/gene therapy clinical trials which fulfill with one of the following requirements: multiregional and non-first in human clinical trials (conducted in both one of the ten medical advanced countries and Taiwan), or investigator-initiated academic clinical trials with the same investigational products that had been used in other clinical trials in Taiwan.

    TFDA will have a continuously review on the clinical regulatory environment such as reviewing system and reviewing efficacy to facilitate the process of getting new drugs to the market. The ultimate aim is to make people have timely access to new drugs.