Taiwan is slated to attend an International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) assembly as an official member following a decade-long effort, in a move that would not only boost Taiwan’s pharmaceutical companies but also bring greater accessibility to foreign drugs to the public, Taiwan Food and Drug Administration (FDA) Director General Wu Shou-mei said.
The ICH is an international organization formed in 1990 by drug regulators of Europe, Japan and the U.S. to facilitate discussions among counterparts to formulate drug regulatory guidelines that are accepted by countries around the world and recognized as global standards for drug review.
During a news conference, Director General Wu said that while drug accessibility is an essential need for the public, many new drugs have faced obstacles from inconsistent regulatory guidelines. These difficulties have made the Taiwan FDA aware of the importance of regulatory harmonization.
In addition, Director General Wu added that having harmonized regulations would allow Taiwanese pharmaceutical companies to avoid difficulties from inconsistent review standards when they apply to market their drugs in overseas markets. Taiwan has worked very hard at gaining official ICH membership by elevating drug quality management, and these efforts have since been recognized by the international community.
While Taiwan has been participating in ICH meetings since 2008, the lack of member or observer status meant that Taiwan’s delegation were unable to attend a number of important meetings. Following years of hard work, Taiwan’s FDA was granted observer status and ascended to official member status in 2018 under the name TFDA, Chinese Taipei, marking a major milestone in Taiwan’s efforts at regulatory harmonization and meeting international pharmaceutical standards.
Director General Wu said that during the past year as an ICH member, the TFDA has actively participated in ICH events and has selected more than 30 experts to attend more than 20 workshops on guidelines.
【2019-05-29 / CNA】
