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Global Inspectors gathering in Taiwan to harmonize the GMP regulation in the field of medicinal products 【Date:2017-09-11】 unit:風險管理組

The 2017 PIC/S Committee Meeting and Seminar, the biggest annual event of PIC/S, take place from September 11th to 15th in Taipei. Nearly 175 GMP inspectors representing 62 regulatory authorities from 52 countries, including the U.S., Canada, U.K., Germany, Switzerland, France, Italy, Netherlands, Denmark, Belgium, Sweden, Japan, South Korea, Singapore, Malaysia, Indonesia, Thailand, New Zealand, Australia, South Africa, Argentina and etc., and representatives from European Medicines Agency (EMA), European Directorate for the Quality of Medicines (EDQM), and United Nations International Children's Emergency Fund (UNICEF) are gathering in Taipei to discuss the harmonization of GMP regulations and its management system in the field of medicinal products.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was founded by European countries in 1970 and presently comprises 49 participating authorities from 46 countries in Europe, Africa, America, Asia, and Australia, to lead the harmonization of GMP regulations and consistency in inspection standards of medicinal products. The PIC/S GMP Guide for medicinal products is considered the most rigorous standard in the world. Although national conditions vary in all participating authorities, pharmaceutical manufacturers should comply with PIC/S GMP Guide and be authorized by participating authorities. Taiwan FDA broke the diplomatic and political impasse, became a participating authority of PIC/S in 2013 ahead of Japan and South Korea., and going to host the PIC/S Committee Meeting and Seminar, the biggest PIC/S annual event, in 2017.

To begin with, PIC/S Committee Meeting is held on Sep. 11th and 12th, to discuss with the development strategies and projects for harmonizing the GMP regulations and enhancing the international collaboration, including reviewing the progress of work plans on revising the standard, global inspector training, and membership application of Iran, Turkey, and Mexico. Representatives from Russia and Saudi Arabia are also invited to the Committee Meeting to express their interest in becoming PIC/S participating authorities. The Chairperson, Deputy Chairperson, and Chairs of Sub-Committees of PIC/S in 2018-2019 will also be elected. TFDA is running for the position of PIC/S Sub-Committee and actively engage in the PIC/S affairs and events to consolidate its membership, raise its international reputation, and enhance international cooperation with other participating authorities via PIC/S platform.

After that, PIC/S Seminar will take place from Sep. 13th to 15th, which is the grandest annual gathering of PIC/S that brings together global GMP inspectors to discuss pharmaceutical GMP. The theme of the seminar is “Quality Control Laboratories: How to Inspect”. Quality Control is part of GMP which is concerned with sampling, specifications, testing and release to ensure that the necessary and relevant tests are actually carried out and materials and products will only be released for use and supply until their quality has been judged to be satisfactory. Discussions involve the latest GMP requirements, out-of-specification (OOS) and out-of-trend (OOT) investigation, data integrity, technical transfer of test methods, and inspection skill of quality control laboratories at pharmaceutical manufacturers. The participants will benefit from the keynotes speakers from the U.S., the U.K., France, Australia, Canada, Singapore, and Taiwan, accompany with workshops discussion to defining more comprehensive quality standards and improving inspection regulations and skills, which in turn benefits the general public.

The Deputy Minister Chi-Kung Ho of Health and Welfare and Dr. Shou-Mei Wu, Director-General of Taiwan FDA, will attend the PIC/S event to deliver opening remarks at the opening ceremony of PIC/S Seminar 2017. The GMP inspectors from Taiwan FDA have also been fully engaged. By working and discussion together with inspector globally will more valuable to our inspector to ensure that the high quality drugs are available to all patients, which in turn also contributes to not only the improvement in the quality of medicinal products but also the reputation of Taiwan pharmaceutical industry.

Please find further information from the followed website:
PIC/S (
https://www.picscheme.org/en/pia-pic-s-training-seminars) and
2017 PIC/S Seminar (
http://pics2017.org.tw/site/page.aspx?pid=901&sid=1148&lang=en)

Appendix: Welcome Video of the PIC/S Seminar 2017
https://www.picscheme.org/en/pia-pic-s-training-seminars