EU's Biotech Act risks patient safety, warns Swedish medicines regulator
Proposed clinical trial rules could disadvantage smaller EU nations while failing to ensure quality safeguards.
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Sweden's medicines agency has raised concerns that the EU's proposed Biotech Act contains clinical trial provisions that could compromise patient safety and create barriers for smaller member states.
The regulator warned that certain proposed rules may disadvantage countries with limited regulatory capacity while simultaneously failing to establish sufficient quality and safety standards.
Smaller EU nations could face hurdles in conducting or approving clinical trials under the new framework, potentially fragmenting the EU's research landscape and slowing drug development.
The Swedish agency's warning adds pressure on EU legislators to revise the Act before final passage.