의약품 품목허가의 취소와 변경

Abstract

Pharmaceutical efficacy, with its safety, is an important criterion for pharmaceutical approval in Korean ‘pharmaceutical and public health Law’, but its violation is frequent up to now. Quantity of principal ingredients contained in a unit of pharmaceutical is the basic method to assess pharmaceutical efficacy and quality. The Supreme Court decision (Supreme Court Decision 1990 Nu 1069 Delivered on May 11, 1990) affirmed for the first time, that lack of principal ingredients contained in a unit of pharmaceutical was one of the revocable causes of pharmaceutical approval. In ‘pharmaceutical and public health Law’, legal theories about revocation and amendment of pharmaceutical approval are enormously influenced by administrative law theories, but nevertheless have considerable differences. Government has the authority of wide and comprehensive control about pharmaceuticals in order to protect the public health, and can revoke and amend pharmaceutical approval in the case of the violation of safety and efficacy criteria. Therefore, it is said that pharmaceutical approval has provisional properties. Good Faith of pharmaceutical companies is respected in the limited scope, and government can revoke and amend pharmaceutical approval to protect the public health, even though they commit no fault in its process or after the approval.