In the past, there used to be a quite distinct cut between medical devices and pharmaceutical products and intersection of devices and drugs occurred only at use. Examples of these kinds of medical devices are PCA pumps and imaging agents.
However, nowadays Drugs are added to devices to add value to medical devices and improve their function and efficiency. Moreover, sophisticated drug delivery systems integrate drugs and devices. We can mention transformal patches, coated catheters and drug eluting stents as some examples.
It is not really clearer if a combination of device-drug should be classified as a medical device or a pharmaceutical product. This becomes extremely important when it comes to regulatory affaires. Currently regulatory systems for pharmaceutical products and biomedical devices are totally different and not always really easy to handle for companies. Mostly this classification is claimed by the company and challenged by authorities. However, that may not end to a same classification in all the regions of the world. These kinds of Complex devices may be accepted in one region as a pharmaceutical product and in the other one as a biomedical device requiring two completely different procedure in the view of clinical trial and regulatory procedures. The problem may be much more important when it comes to devices combined with stem cells, tissue engineered materials and so on.
However, nowadays Drugs are added to devices to add value to medical devices and improve their function and efficiency. Moreover, sophisticated drug delivery systems integrate drugs and devices. We can mention transformal patches, coated catheters and drug eluting stents as some examples.
It is not really clearer if a combination of device-drug should be classified as a medical device or a pharmaceutical product. This becomes extremely important when it comes to regulatory affaires. Currently regulatory systems for pharmaceutical products and biomedical devices are totally different and not always really easy to handle for companies. Mostly this classification is claimed by the company and challenged by authorities. However, that may not end to a same classification in all the regions of the world. These kinds of Complex devices may be accepted in one region as a pharmaceutical product and in the other one as a biomedical device requiring two completely different procedure in the view of clinical trial and regulatory procedures. The problem may be much more important when it comes to devices combined with stem cells, tissue engineered materials and so on.
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