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Taiwan is officially a European Pharmacopoeia Observer, which promotes the internationalization of the drug industry in Taiwan

  • Data Source:Ministry of Health and Welfare
  • Created:2013-12-18
  • Last Updated:2017-02-03

The Taiwan Food and Drug Administration (FDA) formally submitted an application to the European Pharmacopoeia Commission (EPC) to become a European Pharmacopoeia Observer in August 2013. Following considerable effort, FDA Taiwan obtained the support of the Secretary General of the Council of Europe. The application was discussed at the EPC conference held on November 27. Subsequently, FDA Taiwan received notice on December 2, stating that Taiwan has officially been accepted as a formal European Pharmacopoeia Observer. 

Pharmacopoeia is the quality standards for drugs and the technical specifications for inspection methods. This book provides official test specifications, methods, and eligibility criteria, such as raw pharmaceuticals, excipient, finished products, and packaging, for chemical pharmaceuticals, biological pharmaceuticals, and herbal pharmaceuticals. In addition, Pharmacopoeia serves as a basis for drug management in various countries, of which, the European Pharmacopoeia is the most representative. Drugs developed in medically-advanced countries in Europe are required to comply with the standards stipulated in the European Pharmacopoeia. In addition, America, Japan, and other countries have established collaborative relationships that allow them to instantaneously update the latest drug quality standards and inspection techniques. 

The acceptance as a European Pharmacopoeia Observer reflects the considerable effort FDA Taiwan has exerted over the years to join international organizations. This achievement also suggests that the technique to make drugs and the quality of drug in Taiwan have received international recognition. As a member, FDA Taiwan subsequently anticipates the establishment of channels with the European Union member states to engage in technology exchange, such as reviewing the drug technique documents of various health authorities, promoting information exchange in international drug management, and establishing partnerships between numerous cosmetics laboratories. Following Taiwan’s acceptance into the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the signing of the Pharmaceutical Regulatory Cooperation Framework Agreement with Japan, the acceptance as a European Pharmacopoeia Observer is the next key milestone in maintaining drug use safety in Taiwan and enhancing the international competitiveness of domestic drug manufacturers.