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 heavy G-BA plenary on 3 September: seven benefit-assessment resolutions in force immediately, plus two vaccination-directive changes and an Anlage VIIa update still awaiting publication.
By resolution of 3 September 2026, in force the same day, the G-BA set aside its earlier requirements for anwendungsbegleitende Datenerhebung (AbD) and analyses for exagamglogene autotemcel in sickle cell disease — the resolutions of 21 December 2023, 7 November 2024 and 18 September 2025 — and repealed the accompanying 21 December 2023 restriction on which providers may supply the therapy. The G-BA's own Fachnews states the reason plainly: an application-accompanying data collection is not possible. A parallel resolution closed the review of the study protocol and statistical analysis plan.
Why it matters: Read this as an infeasibility finding, not a vindication. The obligation fell away because the evidence could not be generated in practice, so it is a weak precedent for sponsors hoping a registry duty ends once a question is answered — the better read is that AbD can fail on design and recruitment grounds in ultra-rare ATMP populations. Two practical consequences: the Versorgungsbefugnis restriction is gone, removing a hard cap on treatment-centre expansion, but the G-BA will enter any future reassessment without the data it expected, which tends to harden its position on added benefit.
Sources: G-BA Beschluss 7995 · Beschluss 7994 · G-BA Fachnews, 3 Sep 2026
The G-BA adopted separate Anlage XII resolutions on 3 September 2026 for inebilizumab in generalised myasthenia gravis (AChR-Ab+, MuSK-Ab+) and in immunoglobulin G4-related disease. Both entered into force on publication that day.
Why it matters: Two indication extensions landing together sets the reference frame for the whole product before Erstattungsbetrag renegotiation. Myasthenia gravis is now a crowded German assessment field — nipocalimab therapy costs were published only a week earlier — which strengthens the GKV-Spitzenverband's hand on comparator selection and mixed-price construction.
Sources: G-BA Beschluss 7999 · Beschluss 7996
The G-BA resolved on 3 September 2026 on the benefit assessment of mepolizumab in the new indication COPD, in force the same day.
Why it matters: COPD is a high-volume indication, so the added-benefit category and defined subgroups translate directly into addressable population and negotiated price. Biologic entry into COPD also reopens the reference-price and prescribing-economy discussion for the wider respiratory portfolio.
Sources: G-BA Beschluss 7998
The G-BA adopted an Anlage XII resolution on 3 September 2026 for the fixed-dose combination of niraparib and abiraterone acetate in metastatic hormone-sensitive prostate cancer with BRCA1/2 mutations, with prednisone or prednisolone and androgen deprivation therapy. In force the same day.
Why it matters: A biomarker-restricted combination puts companion-diagnostic availability and BRCA testing rates squarely on the access critical path. Watch it against the GKV-BStabG backdrop: the 20% combination discount for new active substances is being abolished from 2027, changing the arithmetic on fixed-dose combination pricing.
Sources: G-BA Beschluss 7997
The G-BA resolved on 3 September 2026 on imlunestrant for ER-positive, HER2-negative breast cancer with an ESR1 mutation, progressing after prior endocrine therapy. In force the same day.
Why it matters: Another biomarker-defined second-line endocrine setting where the appropriate comparator therapy is contested. The subgroup structure fixed here shapes both the negotiated price and the testing pathway that must exist before patients can be identified.
Sources: G-BA Beschluss 7993
The G-BA adopted two resolutions on 3 September 2026 implementing updated STIKO recommendations in the Schutzimpfungs-Richtlinie: one updating the COVID-19 recommendation and removing the recommendation to achieve basic immunity, and one updating travel vaccinations. Both enter into force only after the BMG declines to object and they are published in the Bundesanzeiger.
Why it matters: The Schutzimpfungs-Richtlinie is what makes a vaccination a GKV benefit, so these changes move reimbursable volume directly. Dropping basic immunity narrows the routine COVID-19 cohort. Neither is in force yet — confirm the Bundesanzeiger date with the G-BA before adjusting forecasts.
Sources: G-BA Beschluss 8001 · Beschluss 8000
The G-BA recorded on 3 September 2026 that the BMG did not object to its resolution of 11 August 2026 updating Annex VIIa to the Arzneimittel-Richtlinie. It enters into force once published in the Bundesanzeiger.
Why it matters: Annex VIIa governs substitution and pharmacy-level dispensing, so changes feed straight into aut-idem behaviour and generic share. Entry into force is not yet fixed; confirm the publication date before assuming an effect on Q4 volumes.
Sources: G-BA Beschluss 7959
BfArM published the current Dringlichkeitsliste dated 1 September 2026 as PDF and CSV. Per BfArM's shortage pages, the supply-shortage declaration for inhaled salbutamol was lifted in September 2026.
Why it matters: Listing on the Dringlichkeitsliste unlocks pharmacy substitution flexibilities and changes rebate-contract enforcement. Coming off the list restores normal contract discipline, so affected suppliers should re-check their Rabattvertrag obligations rather than assuming the relaxed regime continues.
Sources: BfArM — Lieferengpässe
Again a quiet week for Austrian pricing and reimbursement: no EKO change and no device-registration rule moved between 2 and 8 September. The activity was in blood and tissue safety.
On 7 September 2026 BASG issued simultaneous updates, based on ECDC and French competent-authority notifications, adding autochthonous WNV regions in Hungary (Bács-Kiskun, Pest), Croatia (Koprivnica-Križevci, Krapina-Zagorje), Serbia (Severnobanatska District), Greece (Heraklion, Rethymno), Italy (Province of Reggio Calabria) and France (Loiret, Gironde).
Why it matters: Six geographies expanded on a single day is a marked escalation of the vector season and directly restricts the Austrian donor pool. Plasma-derived medicinal product supply chains and cell and tissue therapy sponsors sourcing from these regions should expect tighter collection windows through the autumn.
Sources: BASG — What's new · BASG — Messages in brief
BASG published an updated form (F_I365) for applications for a confirmation for the export of products that are not medical devices, dated 7 September 2026.
Why it matters: Administrative, but it matters for borderline products. Where a product has been classified as a non-device, the export confirmation is what third-country authorities ask for, and using a superseded form is a common cause of avoidable delay in shipment release.
No national Austrian device-registration change occurred this week. EUDAMED actor and device registration has been mandatory since 28 May 2026, and Austrian manufacturers and authorised representatives remain bound by the November 2026 legacy-device cut-off.
Why it matters: The absence of national news is not the absence of obligation. Companies still treating the BASG notification route as their compliance anchor should confirm their EUDAMED actor ID and legacy backlog now, and verify their specific position with BASG, since national implementing practice is still settling.
Sources: BASG — Medical devices · EC — UDI/Device registration
The busiest Swiss week in a while: a vigilance-system replacement announced, new pharmacovigilance guidance, and swissdamed support ahead of the year-end transition close.
Swissmedic announced on 4 September 2026 that the Electronic Vigilance System, in service since 2014, is being replaced by ElViS 2.0 to enable exchange of individual case safety reports in E2B(R3) format. Launch is planned for 21 December 2026. MAHs can enter data manually or upload E2B files; uploads in the older R2.1 format can be completed and validated to meet the R3 standard, and Swissmedic will return reports in E2B(R3), E2B R2.1 and PDF. Healthcare professionals see only minor changes, with login via AGOV or HIN. Online training for MAHs is planned for early December.
Why it matters: A hard cutover on a date in the middle of the holiday period, landing on every MAH that reports to Swissmedic outside the Gateway. Safety databases, submission SOPs and vendor contracts need checking against R3 now; the December training is late for anyone who has to change a system rather than a process.
Sources: Swissmedic — ElViS 2.0, 4 Sep 2026
Swissmedic published guidance document MU100_00_001e_WL setting out the requirements for the Responsible Person for Pharmacovigilance. This is the first publication of this guidance, dated 1 September 2026.
Why it matters: Until now the qualification, residency and responsibility expectations for the Swiss RP were largely inferred from inspection practice. A published standard makes them auditable, so companies relying on a shared or regional RP arrangement should re-check it against the document before the next inspection cycle — and before the ElViS 2.0 changeover adds a second compliance variable.
Announced on 3 September 2026, the session covers how to register and manage medical device data in swissdamed.
Why it matters: The timing is the signal: a training session seven weeks before the transition period closes on 31 December 2026 suggests Swissmedic expects a late registration rush. Companies with an unregistered backlog should not treat November as the moment to start.
Registration in the swissdamed UDI Devices module has been mandatory since 1 July 2026, with a transition period to year-end; devices reportable due to serious incidents, FSCAs or a trend have no transition. Fees are CHF 200 for the first UDI-DI and CHF 20 per additional UDI-DI at status "On the market", capped at CHF 10,000 per calendar year, first invoiced from January 2027 with retrospective effect.
Why it matters: Under four months remain. Because fees apply retrospectively to devices already registered, portfolio-rationalisation decisions are cheaper made before year-end than after the first invoice run.
Sources: Swissmedic — swissdamed registration · Registration fee
The updated Mutual Recognition Agreement signed on 2 March 2026 as part of the broader EU–Switzerland package would restore mutual recognition of conformity assessment for MDR- and IVDR-certified devices. It enters into force only once both sides ratify; on the EU side this needs European Parliament consent then Council approval. No ratification step was recorded this week.
Why it matters: Nothing changes until ratification completes: CH-REP appointment, labelling and duplicate registration all still apply. Keep the current regime as the 2027 baseline and treat restoration as upside. Confirm status with Swissmedic and SECO before altering any CH-REP contract.
Sources: SECO — MRA Switzerland–EU · Swissmedic — MRAs
Following Commission Decision (EU) 2025/2371 validating four EUDAMED modules — economic operator registration, UDI/device registration, notified bodies and certificates, and market surveillance — registration became mandatory on 28 May 2026 for all economic operators and for new devices before EU placement. Devices placed on the market before that date must be registered within twelve months of the notice, i.e. by late November 2026. Vigilance and post-market surveillance functionality is expected later, with those obligations anticipated to become mandatory in 2027.
Why it matters: No slippage has been announced, so the November date should be treated as firm. Unregistered legacy devices face market-availability and enforcement exposure from December. Where the exact day matters commercially, confirm it with BfArM or BASG rather than relying on secondary summaries, as both 27 and 28 November are cited.
Sources: EC — UDI/Device registration · EC — EUDAMED · BfArM — EUDAMED
The European Commission published the first JCA report under the HTA Regulation on 9 June 2026, covering tovorafenib (Ojemda) in paediatric low-grade glioma. The HTA Coordination Group approved it on 30 April 2026, with NCPE Ireland as assessor and IQWiG Germany as co-assessor.
Why it matters: IQWiG's role as co-assessor is the practical point for German market access: the JCA and the § 35a dossier are built by overlapping expertise, so PICO divergence between the two is now a self-inflicted problem rather than an unavoidable one. Device JCAs follow on the 2026 work programme, with first device reports expected around year-end.
Sources: EC — Joint Clinical Assessments · SANTE newsroom · G-BA — EU-HTA
The package cleared trilogue on 11 December 2025, COREPER on 6 March 2026 and Parliament's SANT committee on 18 March 2026. A plenary vote has been expected in autumn 2026; as at 8 September 2026 no plenary adoption was confirmed in the sources reviewed for this issue.
Why it matters: Regulatory data protection duration, the transferable exclusivity voucher for novel antimicrobials and the revised Bolar exemption all reshape launch sequencing in Germany and Austria. The text is settled and only timing is open, but nothing applies until Official Journal publication — so do not book the changes into 2027 plans yet.
Sources: EP Legislative Train · Council — The pharma package
The Commission's proposal to amend the MDR and IVDR, published 16 December 2025 and consulted on between 7 January and 19 March 2026, passed the deadline for amendments to Parliament's draft report on 20 July 2026. Technical meetings are expected during autumn 2026, with a plenary vote on Parliament's position anticipated around the turn of the year.
Why it matters: The package targets roughly a 30% cut in administrative burden and more proportionate conformity assessment for lower-risk devices, but none of it is law. Certification planning must continue under the current MDR/IVDR, and the autumn technical meetings are the last realistic window for industry input through national associations.
Sources: EC — Medical devices, new regulations · MDlaw — targeted revision
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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 2–8 September 2026 and was issued on 8 September 2026.