Since joining the Pharmaceutical Inspection Convention and Co-operation Scheme January 1, Taiwan has secured greater access to the global market for its pharmaceutical industry, the ROC Department of Health said July 17.
PIC/S membership represents the international community’s affirmation of Taiwan’s advanced regulatory and inspection standards, the DOH said, which in turn has had positive knock-on effects for local drugmakers.
Because Taiwan’s good manufacturing practice accreditation and inspection system is officially recognized internationally, countries will accept the DOH’s GMP inspection reports as authoritative, eliminating the need to periodically dispatch inspectors to Taiwan’s factories.
Via the PIC/S platform, the Taiwan Food and Drug Administration has launched coordinated factory inspection planning with the European Directorate for the Quality of Medicine and HealthCare, as well as with counterparts in South Africa and the U.K., the DOH said. It will continue forging such ties and mutual accreditation mechanisms with other PIC/S members.
A major benefit of such government-to-government cooperation is reduction of export-related costs, helping local pharmaceutical businesses to expand their foreign markets, the DOH said.
Enhancement of Taiwan’s reputation for quality manufacturing is also boosting business opportunities. The 50 Taiwan drugmakers and suppliers of basic pharmaceutical materials currently accredited as meeting the GMP standards of the PIC/S are enjoying increased ODM and export orders from firms in Europe, the U.S. and Japan. They are also exploring new possibilities for collaborative partnerships.
The DOH said analysis conducted by the Industry Technology Intelligence Services unit of the Development Center for Biotechnology points to strong potential for growth among Taiwan makers of Western medicine.
ITIS projects pharmaceutical exports of NT$12.52 billion (US$417 million) this year, double NT$6.26 billion exports in 2010. PIC/S membership can be expected to further fuel growth, the DOH said.
The DOH added that PIC/S membership will enable Taiwan to take part in the formulation of new international regulatory standards. This will help keep local businesses abreast of the latest trends and buttress development.
Taiwan has been selected to host the 20th meeting of the PIC/S Expert Circle on Human Blood, Tissues and Cells Sept. 9-13, the DOH said, where international experts will gather in Taipei City to discuss quality-control issues and inspection procedures for emerging biomedical products.
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