MHLW holds jurisdiction over the Pharmaceutical Affairs Law and the MHLW makes orphan designation decisions on a case-by-case basis. The decision is based on the opinion of the Pharmaceutical Affairs and Food Sanitation Council (PAFSC), who reviews the scientific report prepared by the Pharmaceuticals and Medical Devices Agency (PMDA). As with other regulatory submissions, Japanese data are considered to be of most value and the application for orphan designation must be in Japanese.
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.
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