新修订的《药品管理法》于2019年12月1日起正式施行。此次药品管理法的修订,对鼓励研发创新、保障药品可及性方面提出了很多举措,最突出的是整部《药品管理法》都贯穿着一个理念:全程管控、全生命周期安全监管与保障。新《药品管理法》由十章增至十二章,最显著的变化就是将药品上市许可持有人以及药品上市后管理单独成章,其重要性可见一斑。
<<The newly revised “Drug Administration Law” officially took effect on December 1st,2019. This revision of the “Drug Administration Law” put forward several measures to encourage research and development innovation and ensure the accessibility of drugs. The most prominent was that the concept underlying the “Drug Administration Law” covered the control throughout the whole process,and full life cycle safety supervision and guarantee. This new version had twelve chapters,two more chapters than the previous version. The most significant change was listing Marketing Authorization Holder(MAH)and post-marketing management of drugs in separate chapters,showing the importance of both.
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