A weekly scan of regulatory changes and news across DE, AT and CH — pricing, reimbursement, clinical trials and device rules — with what each means for market access.
The GKV-Beitragssatzstabilisierungsgesetz (GKV Stabilization Act) was adopted by the Bundestag on 10 July 2026, cleared the Bundesrat the same day, and entered into force on 30 July 2026. It bundles cost-containment measures across statutory health insurance: compressing free-pricing windows, tightening AMNOG early-benefit evidence thresholds, restructuring DiGA reimbursement, and adding transparency and reporting obligations for pharma and medtech. Reporting also points to relief on certain pricing "guardrails" for combination therapies, notably in oncology.
The federal government's Pharma & MedTech Dialogue, launched in January 2026, remained active through the summer, with a broad agenda spanning pricing, research incentives and manufacturing. Commentary flags both high hopes and unclear prospects, and further reform steps are expected beyond the GKV-BStabG.
The Medizinforschungsgesetz continues to bed in: it simplifies clinical-trial and approval processes for medicines and devices, adjusts rules for advanced therapy medicinal products (ATMPs), touches AMNOG, and reorganises BfArM, the Paul-Ehrlich-Institut and ethics committees.
At its June 2026 meeting, the CMDh (with Austria's BASG participating) discussed the new pharmaceutical legislation (NPL), its multi-annual workplan, variations, safety-label variations, multilingual packs and trade-name challenges. Updates to several variation guidance documents and templates are due to align with new European Commission guidelines.
BASG's new medicines information system went live on 10 February 2026, merging the former medicinal-product index, shortages index, announcements and votes into a single portal at medikamente.basg.gv.at.
BASG (through AGES) remains the competent authority for devices in Austria. Manufacturers, authorised representatives and importers register via EUDAMED and the competent authority where established — but until the relevant EUDAMED modules are fully mandatory, Austrian national obligations continue in parallel.
From 1 July 2026, registration of medical devices, systems, procedure packs and IVDs in the swissdamed UDI/Devices module is mandatory, with a transition period until 31 December 2026. From 31 December 2026, a device must be registered in swissdamed to be legally marketed in Switzerland.
The updated EU–Switzerland mutual recognition agreement for medical devices, signed on 2 March 2026, remains in the ratification process. Until it enters into force, Switzerland is treated as a third country: non-Swiss manufacturers still need a Swiss Authorised Representative (CH-REP), importer duties, economic-operator registration, and swissdamed registration.
Under the EU HTA Regulation (applying since 12 January 2025 for oncology medicines and ATMPs), Implementing Regulation (EU) 2025/2086 — adopted 17 October 2025 — finalised the framework for Joint Clinical Assessment (JCA) of selected high-risk devices and IVDs, starting in 2026. The system aligns evidence requirements across member states.
The overhaul of EU pharmaceutical legislation — the "pharma package" — continued through 2026. Notable for market access: a broadened Bolar exemption that expressly covers HTA activities, creating a direct link between the pharma package and the EU's joint clinical assessment framework.
We translate DE / AT / CH regulatory shifts into what they mean for your market access — pricing, evidence and the path to getting paid.
Book a session →This digest is a general, non-exhaustive summary of publicly reported regulatory developments as at early September 2026 and is not legal or regulatory advice. Dates, scope and in-force status change; several items are in transition or ratification. Confirm the current position with the relevant authority (BfArM/PEI, G-BA, BASG/AGES, Swissmedic, the European Commission/EMA) and qualified counsel before acting.