Press Enter to Main Content
您的瀏覽器似乎不支援JavaScript語法,但沒關係,這裡的JavaScript語法並不會影響到內容的陳述, 如需要選擇字級大小,IE6請利用鍵盤按住ALT鍵+ V → X → (G)最大(L)較大(M)中(S)較小(A)小,來選擇適合您的文字大小, 而IE7或Firefox瀏覽器則可利用鍵盤 Ctrl + (+)放大(-)縮小來改變字型大小,如需要回到上一頁可使用瀏覽器提供的 Alt+左方向鍵(←) 快速鍵功能,列印可使用瀏覽器提供的(Ctrl+P)功能。
  • facebook
  • line
  • twitter
  • Print
  • Back

2017 PIC/S Committee Meeting and Seminar conclude successfully in Taiwan with spectacular results

  • Data Source:Food and Drug Administration, Ministry of Health and Welfare
  • Created:2017-09-15
  • Last Updated:2017-09-17

The 2017 PIC/S Committee Meeting and Seminar took place in Taiwan, bringing together 170 official inspectors representing 60 regulatory authorities and three international organization from 50 countries, including the U.S., Canada, the U.K., Germany, Switzerland, France, Italy, the Netherlands, Denmark, Belgium, Sweden, Japan, South Korea, Singapore, Malaysia, Indonesia, Thailand, New Zealand, Australia, South Africa and etc.,. Inspectors worldwide are gathering in Taipei to discuss the GMP regulations and standards in the field of medicinal products for consecutive five days from Sep. 11th to 15th,during which they had exchanges of ideas, inspection experience and techniques, and drafted a universal inspection technical document. The event concluded successfully with impressive results.

The Taiwan Food and Drug Administration, Ministry of Health and Welfare (Taiwan TFDA) became a participating authority of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2013 and has actively engaged in the PIC/S affairs and events ever since to consolidate its membership in PIC/S and deepen friendships with other countries, and be the host authority of 2017 PIC/S Committee Meeting and Seminar in Taiwan. Last year Taiwan FDA was handed over the PIC/S walking stick, which symbolizes responsibility and honor, from the previous organizer, Medicines and Healthcare Products Regulatory Agency (MHRA), in the U.K. With the efforts made by Taiwan FDA and the full support of PIC/S members, global inspectors gathered in Taipei and had intense discussions and exchanges on “Quality Control Laboratories: How to Inspect.” The development of revising the “PIC/S Aide Memoire on Inspection of Pharmaceutical Quality Control Laboratories”, an important guideline on inspection of international quality control laboratories, marks a significant milestone in this seminar. The seminar climaxed with Dr. Shou-Mei Wu, Director-General of TFDA, passing down the PIC/S walking stick to Ellen Morrison, Assistant Commissioner for Medical Products and Tobacco Operations, U.S. FDA.

Taiwan started to implement pharmaceutical GMP in 1982 and has been looking up to the U.S. and Europe to improve pharmaceutical technology since two decades ago. As Taiwan being a member of PIC/S since 2013, and the fully adopted PIC/S GMP Guide to the biotech and pharmaceutical manufacturers in 2015, the efforts Taiwan has made in providing high quality drugs is well recognized, and upgrading the manufacturing techniques to reached a whole new level, on a par with international standard, which is acknowledged by major international pharmaceutical companies. In addition, the GMP certificate issued by TFDA is also recognized by South East Asian countries, Australia, Sweden, Switzerland, Canada, and etc. The 2017 PIC/S Committee Meeting and Seminar was highly praised, making Taiwan an indispensable partner in PIC/S. Taiwan FDA will keep extending its influence in the global community and deepening its partnerships with countries worldwide to let Taiwan FDA gain a foothold in the world and to market domestic pharmaceuticals worldwide.

Attachments