Taiwan set for PIC/S membership in 2013

Taiwan-made drugs could soon be filling the shelves of pharmacies worldwide after the country becomes a member of PIC/S early next year. (Photo: Huang Chung-hsin) Publication Date：10/04/2012 Source： Taiwan Today ByMeg Chang Taiwan will join the Pharmaceutical Inspection Convention and Cooperation Scheme (PIC/S) beginning 2013, providing a major boost to the local drug manufacturing and R&D industries.Kang Jaw-jou, director-general of the ROC Food and Drug Administration, said Oct. 3 that membership in PIC/S is a vote of confidence in Taiwan's pharmaceutical regulation and inspection procedures."Participating in the scheme allows Taiwan to access the latest drug data and better safeguard the health of its people," he said. "This information will also sharpen local manufacturers' global competitiveness, attracting international heavyweights to contract out production or even set up shop on the island."Sources familiar with the matter believe membership in PIC/S will slash the time required for local manufacturers to obtain certification in Canada, Europe and the U.S., while helping establish tie-ups with overseas industry giants searching for outsourcing partners.Taiwan applied to join PIC/S in June 2010. During the comprehensive review process, which included on-site visits, 89 performance indicators were satisfied, including good manufacturing practices, inspection staff management and quality control systems."We also completed revisions to the Pharmaceutical Affairs Act and promoted the implementation of good manufacturing practices in Taiwan firms to bring them on par with global standards," Kang said.These efforts paid off Oct. 2 when PIC/S unanimously approved Taiwan's application, along with that of New Zealand, during its annual seminar in Kiev, Ukraine.The admission of Taiwan and New Zealand early next year brings the number of PIC/S members to 43. Japan and South Korea also lodged their applications in March and April this year, respectively.Established in 1995, Geneva-based PIC/S is an international pharmaceutical inspection system that develops, implements and maintains globalized good manufacturing practices and quality control systems. (JSM)