The evolving process of European combination product review, Part I

Area of Science:

• Cardiovascular Medicine
• Regulatory Science
• Biomaterials

Background:

• Drug-eluting stents (DES) are drug-device combination products requiring specific regulatory oversight.
• Existing European guidelines for medical devices are evolving to address complex combination products.
• The medicinal substance within DES necessitates a detailed review process by drug authorities.

Purpose of the Study:

• To introduce and discuss the new European guideline on drug-eluting stents (DES).
• To outline the European regulatory requirements for the medicinal substance in DES.
• To provide an overview of the evolving regulatory landscape for drug-device combination products in Europe.

Main Methods:

• Review of the new European guideline on drug-eluting stents.
• Analysis of European regulatory requirements for drug-device combination products.
• Discussion of existing and forthcoming stent guidelines.

Main Results:

• The new guideline mandates detailed review of the medicinal substance in DES by European drug authorities.
• Part I of the article outlines current European requirements applicable to DES.
• Part II will cover the new guideline, other stent guidelines, and the regulatory review process.

Conclusions:

• The new European guideline represents a significant step in regulating the medicinal component of DES.
• Enhanced scrutiny of the drug substance in DES is crucial for patient safety and device efficacy.
• The regulatory framework for drug-device combinations in Europe is continuously adapting to technological advancements.