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영어

Biopharmaceutical industry was designated as one of the Korea's ten future growth industries and developing biological new drugs itself is high technology. The biological products arising from their natures request the compliance with the strict manufacturing and quality control standards for commercialization. Considering this, many countries including Korea have developed and complied with separate GMP(Good manufacturing Practice) for biological products in addition to GMP for conventional pharmaceutical products. Today, I am going
to briefly explain about Korea's GMP for biological products and related policy agendas in the future. First, I will review the definition, history of GMP and the legal framework of GMP system in Korean pharmaceutical laws and regulations. Next, I will discuss the point when the GMP Should be applied to during the process of the research & development, pre-clinical trials, clinical trials, registration of products and licence approval of biological products and the reason for these applications. The difference of biological and conventional pharmaceutical products in applying the relevant regulations, scope of GMP for biologicals, additional points to consider in GMP for biologicals compared with conventional products and the major inspection check points & the most common inspection findings will be dealt with. Finally, the initiative policies and their progress for GMP for biological products by us, Biologics Management Team will be introduced.