Germany Promises Harmonized ATMP Rules & More Flexibility For Decentralized Trials

Germany Promises Harmonized ATMP Rules & More Flexibility For Decentralized Trials

March 22, 2024, Pink Sheet

Adem Koyuncu’s commentary was included in a Pink Sheet article examining a proposed move by the German government that would harmonize rules governing advanced therapies and introduce measures to facilitate decentralized clinical trials (DCTs). Adem analyzes the bill and how it has been received by industry leaders.

Adem comments that the measures have been welcomed, but another that would introduce standard contractual clauses for agreements between clinical trial sponsors and sites is being treated with more caution. He also highlights that “several clients in the [advanced therapy medicinal products (ATMP)] space have got different information depending on the state where they asked for it,” he said. “One state may say a drug manufacturing authorization is required for extracting cells for CAR-T manufacturing, while in others it is enough to hold a tissue establishment license.”

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