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  • Generic exclusivity is on the verge of change
  • by Lee, Tak-Sun | translator Choi HeeYoung | Jul 20, 2020 06:19am
The MFDS will release a plan to improve generic exclusivity soon
The revision of the law will include the elimination of the original appeal requirements
Need to expand incentives
The system of generic exclusivity, which grants the monopoly of the market for 9 months to patented generic drugs, is on the verge of change.

It is expected that the measures to improve the right to generic exclusivity that were promoted through the public-private council will soon reveal its outline. As the process of the meeting is delayed, it is expected to be achieved through amendments to the pharmaceutical affairs law this year. The goal is to improve generic exclusivity items.

Generic exclusivity was introduced in 2015. With the signing of the Korea-US FTA, a licensed patent linkage system was introduced in 2012, and through the phased implementation process, generic exclusivity system that grants rights
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