The advanced therapy classification procedure. Overview of experience gained so far

Area of Science:

• Biotechnology
• Regulatory Science
• Pharmaceutical Development

Background:

• The European Union introduced a regulatory pathway for advanced therapy medicinal products (ATMPs).
• Companies developing ATMPs require clarity on product classification to utilize this pathway.
• The classification procedure offers a mechanism for this verification.

Purpose of the Study:

• To review the advantages of the ATMP classification procedure.
• To highlight the benefits for ATMP developers and the European regulatory network.
• To provide an overview of the procedure's uptake and utilization.

Main Methods:

• Review of the European Regulation on ATMPs.
• Analysis of the classification procedure's features and benefits.
• Examination of interactions between developers and the European Medicines Agency (EMA).

Main Results:

• The classification procedure is optional, free, and can be used at any development stage.
• Briefing meetings with the EMA Innovation Task Force aid ATMP classification.
• As of November 10, 2010, the Committee for Advanced Therapies (CAT) finalized 38 classification applications.

Conclusions:

• The ATMP classification procedure is a valuable tool for developers and regulators.
• It promotes early engagement and regulatory clarity for innovative medicines.
• The procedure supports the efficient development and authorization of ATMPs.