The framework will ensure that there are no regulatory barriers to innovative manufacturing and that these products have the same assurances of safety, quality and effectiveness as those made via conventional routes.
Currently, the human medicines legislation is geared for products that can be manufactured at a very small number of sites and supplied globally.
POC products, however, may only have a shelf-life of minutes or need to be highly personalised, so have to be manufactured on demand when the patient is present…
