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The European Parliament voted the reform of General Pharmaceutical Legislation (GPL)
18/04/2024
BACK
On April 10, the European Parliament overwhelmingly backed the reform of General Pharmaceutical Legislation (GPL), marking a pivotal moment in healthcare regulation. With a resounding majority, both the Directive and Regulation were embraced, reflecting a collaborative effort within the ENVI committee.
The list of approved and voted amendments are available on line:
Click here to download the Directive
Click here to download the Regulation
There are numerous references to “in silico methods”, “computational modeling and simulation” or “digital twin” in the original text, which have been strengthened by the accepted amendments. Among them are: "Data generated via in silico methods, such as computational modelling and simulation, molecular modelling, mechanistic modelling, digital twin and artificial intelligence, where appropriate, could also be used to support regulatory decision making". This llustrates the growing recognition by European authorities of in silico methods for regulatory approval.
The executive summary highlights seamless discussions and broad endorsement, signaling a united front across party lines. Key stakeholders stress the significance of this vote in addressing healthcare challenges and enhancing market attractiveness.
Although there will still be a long way to go before the full adoption of computer modeling and simulation for regulatory approval, the adoption of GPL reform represents a significant step forward in shaping the future of regulation healthcare in the EU.
