Taiwan Seeks to Join TPP with Draft Pharma Law Amendments

摘要

Taiwan has released a draft amendment to its Pharmaceutical Affairs Act in a bid to join the Trans-Pacific Strategic Economic Partnership Agreement (TPP). Taiwan's laws are already mostly in line with the TPP's IP provisions. However, on measures relating to pharmaceutical products, there are discrepancies regarding patent linkage and data exclusivity for pharmaceuticals and biologics. Therefore, the Taiwan Food and Drug Administration (TFDA), the Central Competent Health Authority, has drafted amendments of the Pharmaceutical Affairs Act (PAA) and held public hearings on these proposed changes.