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Pharmaceutical Distribution

Because of their special characteristics, pharmaceutical products have always been subject to supervision by the health competent authority and regulation by pharmaceutical laws in different countries. In Taiwan, pharmaceuticals are subject to the protections in the Pharmaceutical Affairs Act and the current Good Manufacturing Practices for drugs (cGMP). Driven by globalization, the global pharmaceutical market is increasingly active. At the same time, due to considerations of cost and effectiveness, a growing number of major international pharmaceutical firms are adopting global production strategies, and implementing various stages of production at pharmaceutical plants in different countries; these firms also engage in global marketing in order to achieve the goal of worldwide sales.


The domestic pharmaceutical industry has faced daunting international challenges in the wake of Taiwan's accession to the WTO. In order to enhance the quality of Taiwan-made pharmaceuticals, the Department of Health announced the implementation of GMP in May 1999, and began promoting PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) GMP in 2007. In the case of drugs produced by pharmaceutical manufacturers that have not yet passed PIC/S GMP, health insurance drug price applications cannot be made after January 1, 2015. Relevant regulations govern the validation of pharmaceutical manufacturing equipment, processes, and analytical methods, and seek to protect pharmaceuticals from risk of deterioration in the face of external environmental factors in the storage and transport processes during global distribution. Because of this, pharmaceutical firms must consider the changes in climate encountered in different areas during the shipment process, and the various aspects of long-distance land, sea, and air transportation vehicles. Special products such as biotech drugs must be kept in an appropriate temperature range, and may require continuous temperature (and humidity) monitoring. Thorough records must be kept to ensure the traceability of drugs throughout the transport and sales process.


To ensure that the predetermined quality of drugs is maintained after they leave a GMP pharmaceutical plant and are transported to distributors, pharmacies, or hospitals, various countries have determined Good Distribution Practice (GDP), which prescribe guidelines to be followed by the pharmaceutical transport industry. Today, GDP issues are increasingly important.



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