厚生労働省 (MHLW) 與TFDA 藥品查廠協議 !!

TFDA and MHLW to Sign Cooperation Agreement by Year-end 2012/11/21 Taipei, Nov. 21, 2012 (CENS)--The Taiwan Food and Drug Administration (TFDA) under the Department of Health is scheduled to sign a cooperation agreement with Japan`s Ministry of Health, Labour and Welfare (MHLW) by the end of 2012, according to TFDA`s director general Kang Jaw-jou. The agreement will first address pharmaceutical and drug-factory certification in 2012, then expand into medical devices, Kang said. In conjunction with the pharmaceutical administration reform by the Japanese government, which requires to raise the adoption rate of generic drugs to 30%, at least 17 Taiwanese pharmaceutical makers have been field-certified by Japan`s MHLW and are ready to supply pharmaceutical companies in Japan. In addition to Japan, Kang said, TFDA will also set up a contact window with its counterpart in Malaysia and try to form a cooperation scheme by the end of 2012. China, South Korea and Japan have been trying to form a medical/healthcare alliance, Kang said, and Taiwan might be marginalized after setting up the cooperation. Industry sources said that Taiwan has become a member nation in Pharmaceutical Inspection Cooperation Scheme (PIC/S), whose mission is to lead the international development, implementation and maintenance of harmonized Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products. So, qualified pharmaceutical makers on the island are expected to win flooding orders from customers in Japan and the U.S. Many local companies have won big-ticket orders from major Japanese pharmaceutical firms, and some have tapped into the Japanese market. The source added that currently the Japanese market has strong demand for hormone, anti-biotic, Penicillin, and anti-cancer drugs. PIC/S-certified drug factories in Taiwan are expected to win more and more orders.(by Quincy Liang)