Combinations of Medicinal Products/Drugs, Medical Devices and/or Biologics are becoming more and more important for the market, e. g. for the delivery of a medication. Such “Combination Products” meet two worlds: the pharmaceutical regulation world and the world of the Medical Devices Regulations.
In the EU the GMP requirements for Medicinal Products are laid down in the GMP Guideline based on an EC regulation. The medical devices industry is regulated now by an EU Medical Device Regulation (2017/745) The distribution of Medical Devices in Europe is based on a CE Certification. Medical Devices Inspections are primarily performed by Notified Bodies.
The basis for the approval process of Medicinal Products /Drugs is for both the EU and the USA the ICH Common Technical Document (CTD). Inspections are performed by authorities. In the USA, there are special approval processes for Medical Devices.
The US-FDA has developed own GMP regulations for Drugs (21 CFR 210/211) , Medical Devices (21 CFR 820), Biologics (21 CFR 600 – 680) and tissue-based products (21 CFR 1271) So far, there had been no standalone GMP regulations for combination products. This has changed only at the FDA since 22 July 2013 with the publication of FDA’s 21 CFR Part 4 (cGMP Requirements for Combination Products). An Office of Combination Products is responsible for this products in the USA. Until now, there is nothing comparable to 21 CFR 4 regarding Combination Products in the EU.