科研之友
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摘要
In order to solve the obstacles existing in China's 'export only' vaccine export supply to the world, analyze the problems in the supervision path, and provide reference for the establishment of regulatory coordination path. Literature research method and comparative research method were used to study the regulatory paths and advantages and disadvantages of 'export only' drugs in the United States, the European Union, and South Korea. It was found that the United States has established a review system for classified export products, and the European Union has established "export only" product science, South Korea reviews 'export only' products separately. It is recommended that China's drug regulatory agencies establish procedures for entrusted review, entrusted batch issuance and GMP inspection for 'export only' vaccines and implement the regulatory path of Article 98 of the "Drug Administration Law" to encourage the export of vaccines.
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