Executive Yuan : Taiwan Joins the PIC/S International Organization Ahead of Japan and South Korea

 Presenting New Opportunities for Biotechnology Industries 10/11/2012| 10:57pm US/Eastern Taiwan Joins the PIC/S International Organization Ahead of Japan and South Korea; Presenting New Opportunities for Biotechnology Industries The Food and Drug Administration of the Department of Health has finally succeeded in knocking the gate into the PIC/S international organization ahead of Japan and South Korea, and Taiwan will become an official member of the PIC/S from January 1st of next year (2013). This not only means that we will be able to share information on international pharmaceutical safety to ensure public drug safety, but also demonstrates the international approval of the GMP regulations, management systems and auditing standards of our domestic pharmaceutical companies, which will significantly improve the international image of our country and enhance the international competitiveness of our domestic pharmaceutical industries. Moreover, through this platform we can establish a mutual GMP approval system with other countries to avoid repeated inspections, which will facilitate the expansion of the export trade of domestic pharmaceuticals and also attract foreign capitals in investing and building manufacturing sites in Taiwan or in entrusting our domestic pharmaceutical companies with the manufacturing of their product to create new opportunities for our domestic biotechnology and pharmaceutical industries!Since the establishment of the Food and Drug Administration of the Department of Health in 2010, its staff has been actively preparing and seeking opportunities to join the Pharmaceutical Inspection Convention and Co-operation Scheme (PIC/S). After the submission of the PIC/S membership application in June 2010, in addition to going through a series of strict and careful evaluation processes, such as written reviews and on-site inspections, covering up to 89 indicator requirements, including rules and regulations, GMP standards, auditing human resources, quality system, the application had to be agreed upon by all PIC/S members to be qualified for membership. To comply with the PIC/S qualification requirements, during the application period, the FDA actively completed the legislative processes for the Pharmaceutical Affairs Act Amendments and the measures for promoting the implementation of international PIC/S GMP standards in pharmaceutical companies, to strengthen our GMP management systems and to bring it in line with the international practice. Finally, in the 35th PIC/S Committee Meeting in Kiev, Ukraine on October 2nd of this year (2012), Taiwan and New Zealand were both agreed by all the members to "become official members of the PIC/S, effective from January 1st of next year (2013)".PIC/S is an official international organization composed of the drug and health authorities of all the member countries. It is dedicated to promoting the standardization of pharmaceutical GMP regulations and auditing qualities and to providing an international cooperation platform. There are currently 41 member countries across 5 continents worldwide, the majority of these members are from EU countries. Other countries, such as USA, Canada, Australia, Singapore, Malaysia, Israel, and South Africa are also members of the PIC/S. Countries in application processes include Japan, South Korea, Brazil; Hong Kong and Mainland China also expressed their interest in joining the PIC/S.