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On July 28, Dr. Minda Bi, Vice President of Langhua Pharmaceuticals, was invited to attend Drug Times' live broadcasting room to explain the regulations and guiding principles related to pediatric drug development in Europe and the United States. He discussed how to help global pharmaceutical companies better promote pediatric drug development and how to learn from the regulations in Europe and the United States to help domestic pediatric drug development align with international standards. He stated that the U.S. has both mandatory regulations (PREA) and incentive regulations (BPCA) for pediatric drug development, as well as supplementary regulations (RACE for Children Act) for oncology drugs. These laws are moderate and relaxed in terms of regulation and are worth Chinese pharmaceuticals taking note of. Europe is similar to the United States, but they are more stringent in terms of mandatory regulations. From the incentive side, the European market sales extend longer, so the space for profitability is greater. Overall, The U.S. and Europe have made the development of regulations for pediatric drug development the key to making up for the lack of pediatric drugs. Only clear and precise rules can guide pediatric drug regulation and orderly development.
Please watch the video record of the broadcast through Tencent Video or BiliBili.
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