Now possible: One global QMS for Pharma Combination Products

Global QMS for Pharma Combination Products

The following pages contain an amendment by Combination Products Device Specialists. This amendment focuses on Single Integral Drug-Device Combination (DDC) products and Single Entity Combination products (non-CE marked devices) as described in the EFPIA’s document, “EU-US Quality Management System (QMS) Requirements Comparison for Drug-Device Combination Products and Medicinal Products Co-packaged with Medical Devices.” Published on August 23, 2022, by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the document provides an industry perspective on the similarities and differences between EU and US Quality Management System requirements for Drug-Device Combination Products and Medicinal Products co-packaged with medical devices. This comparison is based on the respective regulatory pathways of the EU and the US., i.e.:
– For Europe (EU):
o EU medicinal product Directive 2001/83/EC and the related Pharmaceuticals Quality System requirements, as set forth in Eudralex Vol. 4 Ch. I
o European Medical Device Regulations MDR 2017/745
o EMA Guideline on quality requirements for medicinal products used with medical devices (EMA/CHMP/QWP/BWP/259165/2019), EMA Questions & Answers (Rev 2 – June 2021) on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)).
– For US:
o US 21 CFR PART 3.2 Product Jurisdiction – Definition,
o 21 CFR PART 4 Regulation of Combinations product,
o 21 CFR PART 862-892 Devices Regulations,
o 21 CFR PART 820 Quality System Regulation.
– For both EU and US: ICH Guidelines Q8 – Pharmaceutical development, Q9 – Quality risk management and Q10 – Pharmaceutical quality system.

With the mandatory revision of 21 CFR 820 effective February 2, 2026 (transitioning QSR to QMSR based on ISO 13485:2016), we have amended the EFPIA document. This revised document compares the quality management system requirements for Drug-Device Combination (DDC) products. It serves as a tool for industry and regulators to identify and compare the applicable regulatory requirements.

Dirkjan Bakker, PhD
René van Melick, PharmD
January, 2025