Drug/Device Combination Products IFF erfagruppemøde 31 Maj 2017 /Ingrid Malmberg

Agenda 15:30 – 15:45 Velkommen samt en kort intro til dagens emne 15:45 – 16:15 Gruppearbejde 16:15 – 16:25 Kort pause 16:25 – 17:00 Præsentation af gruppearbejde samt diskussion 17:00 – 17:30 Emne for næste møde Udveksling af erfaring med ny lovgivning og guidelines Udveksling af erfaring med myndighedsinspektioner Udveksling af erfaring med kurser og konferencer, både før og efter deltagelse

Ny lovgivning for Combination Products EU Medical Device Regulation. April 2017 http://ec.europa.eu/growth/sectors/medical-devices/regulatory- framework/revision_da Concept paper on developing a guideline on Quality requirements of medicinal products containing a device component for delivery or use of medicinal products. EMA, published 10 November 2016, End of Consultation 16 May 2017 http://www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webCo ntentId=WC500221747&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products. FDA January 2017 https://www.fda.gov/RegulatoryInformation/Guidances/ucm126198.htm

Medical Device Regulation (preamble) (10) Products which combine a medicinal product or substance and a medical device are regulated either under this Regulation or under Directive 2001/83/EC (medicinal products for human use) of the European Parliament and of the Council. The two legislative acts should ensure appropriate interactions in terms of consultations during pre-market assessment, and of exchange of information in the context of vigilance activities involving such combination products. For medicinal products that integrate a medical device part, compliance with the general safety and performance requirements laid down in this Regulation for the device part should be adequately assessed in the context of the marketing authorization for such medicinal products. Directive 2001/83/EC should therefor be amended. Annex I: General safety and performance requirements

EMA’s Concept paper on developing a guideline on Quality requirements of medicinal products containing a device component for delivery or use of medicinal products Guideline on dossier requirements for medical devices that are supplied along with medicinal products where a device is necessary for adminstration or localisation (site- specific delivery) of the medicinal product. To develop a guideline on quality aspects of the dossier requirements for Drug-Device Combination Products for Marketing Authorisation applications, line extension applications and variations to show that the combination has been appropriately designed and controlled and can be used correctly in the intended clinical situations Drug Device Combination products’ fitness for the intended purpose (e.g.) administration of a medicinal product) needs to take into account the Quality aspects of the device in itself and its use with the particular medicinal product, as well as the complexity of the device component, the patient characteristics, the caregiver characteristics where relevant and the clinical situation in which the Drug-Device Combination Product is used. (Usability studies)

FDA’s cGMP for Combination Products – Design Control and Risk Management Quality by Design principles (ICH Q8 Pharmaceutical Development can be leveraged) or Design Control waterfall model can include pharmaceutical development Har I fastlagt en kombineret udviklingsproces for Combination Products? Risk analysis should include considerations for the combination product as a whole to identify risks associated with its design, manufacturing processes and intended use Har I risikoanalyser iht. ISO 14971 for det samlede kombinerede product; hvem er ansvarlig for at holde den opdateret og hvordan både før og efter lancereing af produktet?

Ny lovgivning for Combination Products Hvad betyder det for jeres produktudvikling og registreringsproces? Hvorledes opdaterer i eksisterende produkter - life cycle management of legacy products? Hvad gør i anderledes nye udviklingsprojekter for combination products?