Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Considerations on regulatory requirements for registration of drug-device combination products in Canada and the European Union ***

Olguta Stanescu (Abschlußjahr: 2020)

Summary
Language: English
The aim of this thesis is to compile relevant, in particular regulatory aspects, regarding drug-device combination products in Canada and the European Union, to understand and present the current situation and identify the challenges of manufacturers, to reveal similarities and differences, and to note whether the manufacturers can export their approved products from one region to another.
Canada has been chosen as it has a long history in regulating and dealing with combination products in contrast to the emerging regulation of the European Union which is still optimizing its approach and regulatory framework for this domain.
In Canada there are specific designated legislative provisions for drug-device combination products, stipulated in Policy documents, which were created to ensure that patients have timely access to drug-medical device combination products by establishing a single window approach with a more efficient submission processing system.
Drug-device combinations that meet Policy’s definitions will be registered in Canada either as medicinal product or as a medical device according to the principal mechanism of action by which the claimed effect or purpose is achieved. In most cases, the distinction between devices and drugs is clear and these products can be easily classified according to the definitions, but in circumstances where a product does not clearly fall under the existing definitions, the classification of a combination product – as drug or as medical device – is decided following a procedural process.
In the European Union there are no specific legislative documents to regulate drug-device combinations, but these have been addressed under the Art. 1 (3) and Art. 1 (4) of the Directive 93/42/EEC and in Art. 1 (8) and Art. 1 (9) in connection with Art. 117 of the Regulation (EU) 2017/745 from the perspective of the medical devices. Both legislations’ approach is based on the way in which a medical device is put into service and placed on the market with a medicinal component resulting in two different types of combinations - integral and non-integral drug-device combinations. The specific documentation to register a drug-device combination slightly differs whether it is an integral or a non-integral combination.
Integral drug-device combination products are assessed and regulated based on the greatest contribution to the therapeutic effect and the entire product is registered either as a medical device or a medicinal product, while the non-integral combinations are regulated separately for each component.
In both cases, the core concept is that the Notified Body assesses whether the devices meet the relevant General Safety and Performance Requirements set in Annex I of the Regulation (EU) 2017/745, while the Competent Authorities evaluate the device`s specific aspects of safety and performance relevant to the quality, safety and efficacy on the medicinal product part.
Both Canada and the European Union have a similar approach to regulate drug-device combination products. This became possible after Canada amended its regulation on drug-device combinations to harmonize its regulatory requirements with both FDA and EU requirements and to assist in the development of mutual recognition agreements with those jurisdictions.
Pages: 48, Annexes: pages: 12