EU Commission urges EMA to fast-track Biotech Act preparations

The European Commission has issued a statement urging the European Medicines Agency to accelerate work on the upcoming Biotech Act, which aims to streamline regulation of advanced therapies.

The Commission said the agency should prioritize key steps such as updating assessment guidelines and preparing a framework for cross‑border cooperation.

The call comes as regulators in other regions, including the U.S. FDA, are also focusing on transparency, with the FDA releasing a roadmap that proposes public disclosure of new drug applications and inspection reports.

Stakeholders will be watching how quickly EMA can respond, as the Biotech Act is expected to impact the development timeline for gene and cell therapies in Europe.