EMEA Guidance Recommends DES Biocompatibility Tests
Manufacturers of coronary drug-eluting stents (DESs) should provide the results of biocompatibility tests of the bare-stent platform, according to a final guidance by the European Medicines Agency’s (EMEA) Committee on Human Medicinal Products (CHMP).
Biocompatibility test results for all relevant materials, including carrier and stent material, must be submitted to the national competent authorities (NCAs) and the EMEA, and firms should document the extent to which testing conforms to ISO 10993, CHMP says.
The guidance, which becomes effective Dec. 1, covers the clinical and nonclinical aspects of the assessment of ancillary medicinal substances contained in DESs. It describes a range of drug-device situations and the data required to adequately evaluate the drugs contained in the stent.
It defines four types of combinations:
- Type A — The medicine used in the investigational stent is currently used in a CE-Marked DES with the same indication and comparable dose-release characteristics.
- Type B — The drug in the combination is used in another CE-Marked DES with the same indication but different release characteristics.
- Type C — The medicinal substance is known to the NCA as an active pharmaceutical ingredient (API) or formulated drug product in an authorized medicinal product but not in a CE-Marked DES.
- Type D — The drug substance is a new API not previously recognized by the NCA either as an authorized drug or in a CE-Marked DES.