EMA to cement ACT EU pilot; MHRA unveils AI-era regulatory strategy

The European Medicines Agency announced that in January 2027 it will make permanent a pilot project that assists sponsors in preparing clinical trial applications, turning a temporary scheme into a lasting tool.

The ACT EU pilot, originally launched as a short‑term initiative, is intended to streamline the early stages of trial design and submission, reducing administrative burden for developers.

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency released a multi‑year strategy aimed at modernising regulation for artificial intelligence and personalised medicine. The plan outlines steps and commitments through 2030 to keep pace with rapid scientific advances and speed the delivery of safe treatments.

Both actions signal a broader European effort to update regulatory frameworks and support faster, more efficient drug development in a technology‑driven landscape.