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

2017 PIC/S Committee Meeting and Seminar conclude successfully in Taiwan with spectacular results 【Date:2017-10-17】 unit:風險管理組

    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 FDA received highly positive affirmation from all delegates. The PIC/S Chairman, Mr. Paul Hargreaves (UK/MHRA), emphasized that PIC/S is very proud that Taiwan FDA acceded as a full member in 2013 and it is honor and privilege that Taiwan organized this very successful annual 2017 PIC/S Seminar.(refer to attachment). Through this journey in Taiwan, inspectors worldwide had experienced on Taiwan fascinating traditions and customs. Taiwan FDA has successfully enhanced the international friendship.

    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.

Attachment: Message from PIC/S Chairman.

Photo 1: 2017 PIC/S Seminar delegates.

Photo 2: Taiwan FDA handed over the PIC/S walking stick to U.S. FDA.

Video: Highlights of the Seminar (https://drive.google.com/file/d/0B7ZfaG1oce-4Z2tyd0t4N0dhLW8/view?usp=sharing).

Photos