What are Combination Products and regulations governing them ?
In this article, we are going to see the outline of the combination products and their regulations. so what are combination products – In the US combination products are defined in 21 CFR 3.2(e). and in the EU combination terms are not used instead they use single integral or non-integral
In general, a drug, biologic, and device any of these two or more components combined are called combination products.
In the US the Combination Product is a product comprised of two or more regulated components, that are physically, chemically, or otherwise combined or mixed and produced
Types of Combination Products in the US
- Single Entity Products
- Co – Packaged Products
- Cross-labelled Products
Types of Drug-Device Combinations In the IEU
- Integral DDCs – Prefilled syringe
- NON-Integral DDCs which include referenced and copackaged – syringe +vial of drug, imaging agents and devices
Regulation Of Combination Products in US: The office of combination products plays a main role, and it directs the combination products to CDER /CBER/CDRH based on primary mode of action i.e. is drug, device or biologic. The office of combination products involves in developing the regulations, policies for the combination products.
In EU the combination products are regulated as either medical devices or medicinal products based on the primary mode of action. for drug or biologic Directive 2001/83/EC and for medical devices EU MDR (2017/745).
This is just an overview of combination products regulations in EU & US , We are going to understand deep in the coming articles.