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  • EU revises pharma package law for the first time in 20 years
  • by Kim, Jin-Gu | translator Alice Kang | Jun 11, 2025 06:02am
to improve access to generic medicines
European Council approves the revision; final approval by European Parliament pending
Innovative drug manufacturers to enjoy 8 years of data exclusivity and up to 2 years of regulatory protection
Intellectual property rights waived for generic and biosimilar drugs to support early market entry
The European Union (EU) is pushing for revisions to its ¡°Pharmaceutical Package¡± law on major drugs for the first time in 20 years.

The core of the revision, which is now awaiting final approval by the European Parliament, can be summarized as expanding the exclusivity of innovative drugs and strengthening supply obligations within Europe. In addition, measures such as exempting relevant intellectual property rights are being promoted to improve access to biosimilars and generics.

According to the Korea Biotechnology Industry Organization on the 10th, the European Council (EC) recently agreed to the European Commission's revision of the ¡°Pharmaceutical Package.¡± The only remaining procedure is the final app
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