15 March 2018
The issues linked with combination products evaluation: how to make the novel solution available for patients?
Due to the quick progress in many fields of life, new laws have to be created. Notably in the field of healthcare, where the human health is the crucial factor, the products need to be thoroughly tested prior to entering the market.
More like a medicine or rather a device?
In case of some products it is not so easy to fulfil all the rules. For example, combination product that consists of a mechanism and an active ingredient might be tricky to examine. It can be hard to specify which component plays the main part in the whole product: the biological (pharmaceutical) one or the device element. To assist in the final choice, a dedicated algorithm was devised. Due to that aid, the producer can recognize which agency should he contact . Nowadays a wide range of appliances like the described are being designed, so there is a big chance that something similar has been created in the past. This may make the choice simpler and as a result, the assessment can be shortened.
The future path of medicine
Drug-releasing stents or special wound bandages – combination products are becoming reality, not only a fiction in modern times. They can increase the comfort of living for many of potential recipients. But in order to make it happen, strict evaluation is needed. In the end, the product must be sufficiently safe. Like any implant or medicine that has unblocked contact with the body, safety is the critical factor here.
When a given product passes all the tests, it can help with some diseases that were so far hardly curable. The road is definitely full of obstacles, but the effect is worth the struggle.