Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Comparison of the Regulatory Environment to Authorise so-called Combination Products Consisting of a Drug and a Medical Device in the US and the EU ***

Dr. Christian Kutzleb (Abschlußjahr: 2008)

This thesis presents the regulatory environment of medical products combining drugs and/or biologics and devices, so-called combination products to provide an overview and insight for their authorisation in the US and the EU, to aid the development of such products by companies unfamiliar with the particular requirements and illustrating the pharmaceutical developers perspective. The current status of applicable legislations and guidelines have been compared and by means of five types of combination product, exemplified with marketed products and concluded with an outlook on future trends and provisions.

For both regions US and EU legal basis of drug-device combination products originates from medical device law. These products are either regulated as drug/biologic or device, but the term is defined and used differently. In the US drug-device combination products are plainly designated as drug-device, drug-biologic, biologic-device and drug-biologic-device containing products regulated by assignement to one of three responsible FDA medical product Centers, based on the products primary mode of action. In contrast, the European medical device legislation provides two conditional clauses differentiating between devices for drug delivery or devices incorporating drugs with ancillary action. The design, use or the impact of the drug on the intended purpose of the combination product determine the authorisation as drug or device. In the EU, the term “combination product” is also often used for fixed combinations which refers to one or more combined active ingredients in one formulation and which represents no integral part of this thesis.

Drugs and devices both have their own regulatory guidelines and/or standards to follow which will also also apply for products combining drug and devices. However, often combination products have to deploy their own development strategy and only few guidelines are available for them in particular. Drug-eluting stents, albumin-containing media, devices coated with growth factor, antibiotic-containing bone cements and collagen fleeces are presented with their regional differences and regulatory status as far as possible by publicly available information. However, the highlighted products may not be considered as representative for typical drug-device combination products but demonstrate why a product could be regulated as either a device in one region or as a drug in another. In addition, a survey was performed at six European NCAs and the EMEA to obtain missing information on conducted consultation procedures and the assessment of drug-device combination products authorised as drugs or devices.

The next generation of innovative combination products, as for example cell/tissue containing devices and therapeutic nanoparticles, will create new opportunities for novel therapies and dispose the next challenges for developers and regulators to serve the public health.

Pages: 92, Annexes: 4 pages : 7