Market-access intelligence for life sciences — a weekly scan of DE, AT and CH regulatory changes, with what each means for pricing, reimbursement and getting paid.
A device-reimbursement comment window, an ATMP benefit assessment running alongside EU JCA output, a critical cardiology shortage and a BfArM process change.
The G-BA issued a resolution opening the formal statement procedure on a draft decision covering full implantation of a cochlear implant for sensorineural severe-to-profound hearing loss. Written statements are due by 12 October 2026, with an oral hearing scheduled for 12 November 2026.
Why it matters: This is the live window to shape the reimbursement corridor for a high-risk implanted device (Section 137h-adjacent) before the G-BA finalises its position — statements filed after 12 October will not be considered.
Sources: G-BA Beschluss 8007 (10.09.2026)
The G-BA's early benefit assessment for onasemnogene abeparvovec (Itvisma, Novartis) in the extended SMA population (patients aged 2+ with ≥4 SMN2 gene copies, types 2/3/4) began on 1 August 2026. The dossier assessment is due on 2 November 2026, with a G-BA decision expected end of January 2027. In parallel the Commission published a JCA report on an SMA advanced therapy on 7 September and refreshed its list of ongoing JCAs on 10 September.
Why it matters: One of the first visible cases of EU-level JCA evidence running concurrently with a German AMNOG procedure for an ATMP — a template for how JCA clinical conclusions will feed (or not feed) national dossiers once JCA becomes the standard reference.
Sources: G-BA Nutzenbewertungsverfahren 1383 · EC — JCA report on SMA ATMP · EC — updated JCA list
The Federal Ministry of Health notified a supply shortage for digoxin- and digitoxin-containing medicines on 8 September 2026, after Teva reported packaging-related delays for Digitoxin AWD 0.07 expected to last into late January 2027. The German Cardiac Society (DGK) classifies the shortage as critical: there is no aut-idem alternative, and switching patients to digoxin requires a dose adjustment for renal clearance.
Why it matters: Companies with cardiology or hospital-supply portfolios should check BfArM's shortage list before assuming continuity for these substances into Q1 2027, and flag the DGK position paper to prescribing customers.
Sources: BfArM — Lieferengpässe · DGK position paper
Secondary reporting indicates that, from 1 September 2026, BfArM's slot-allocation regime for assessment capacity also applies to purely national marketing-authorisation procedures, alongside a new digital PharmNet.Bund form for ENR/EUV applications. We have not yet located BfArM's own notice confirming the exact scope.
Why it matters: If confirmed, this changes timeline planning for purely national (non-CP, non-MRP/DCP) filings in Germany. Confirm current slot requirements directly with BfArM before committing to a Q4 2026 filing date.
A quiet week in Vienna: routine market surveillance only.
We found no new Austrian legislation, BASG/AGES policy change or Erstattungskodex development dated to this window. BASG activity was limited to scheduled eServices maintenance (8 September) and routine market-surveillance notices; the most recent Erstattungskodex amendment on record (the 257th) dates to late January 2026.
Why it matters: Nothing to action for Austria specifically. The items to carry forward — the EU pharma package and the MDR/IVDR revision — apply to Austria once adopted.
Sources: BASG — home / official announcements
A new device-registration fee in force and an eSubmission change on the horizon.
Following the Federal Council's approval of the revised Swissmedic Fees Ordinance, a registration fee applies in swissdamed: CHF 200 for a manufacturer's first product and CHF 20 for each additional product with "on the market" status, capped at CHF 10,000 per calendar year. The ordinance also raised Swissmedic's hourly rate to CHF 270 (unchanged since 2002), effective 1 July 2026. A transitional period for existing registrations runs to 31 December 2026.
Why it matters: Device and IVD companies selling in Switzerland should add the fee to their Swiss compliance budget now, and confirm which products still need registering before the window closes on 31 December.
Sources: Swissmedic — Fees Ordinance revision · swissdamed registration obligation
Swissmedic confirmed it intends to complete technical implementation of eCTD v4.0 by the end of 2026, with go-live during 2027 after pilot testing. It also announced a re-election of the full Agency Council for 2026–2029 and a federal funding increase tied to performance-improvement targets.
Why it matters: Sponsors planning Swiss submissions on a 2027 timeline should prepare for eCTD v4.0 rather than the legacy format.
The Commission published a Joint Clinical Assessment report on an advanced therapy for spinal muscular atrophy on 7 September 2026, and an updated list of ongoing and completed JCAs on 10 September: 15 JCAs initiated to date under the 2026 HTACG work programme, which for the first time brings selected high-risk medical devices into scope.
Why it matters: See the Itvisma item above for how this JCA output lands on a German dossier in real time — a useful precedent for any ATMP or oncology asset entering JCA scope.
Sources: EC — JCA report on SMA ATMP · EC — updated JCA list
We advise life-sciences companies on pricing, reimbursement and regulatory strategy across Germany, Austria and Switzerland. Book a call to work through what these changes mean for your portfolio.
Book a session →Disclaimer. This digest is prepared by BCA (bcaun.de) for general information only and is not legal advice. Regulatory positions change quickly: every item marked Transition, Watch or In ratification is not settled law, and dates, scope and entry-into-force can shift. Confirm any such item directly with the competent regulator — BfArM, PEI, G-BA or GKV-Spitzenverband in Germany; BASG/AGES in Austria; Swissmedic in Switzerland; the European Commission or EMA at EU level — before acting. This edition covers 8–15 September 2026 and was issued on 15 September 2026.