← All editions The three that matter most
- EU Joint Clinical Assessment output starts meeting Germany's AMNOG track for gene therapy. The European Commission published a JCA report on an advanced therapy medicine for spinal muscular atrophy on 7 September, while the G-BA's own national benefit assessment for Novartis's Itvisma (onasemnogene abeparvovec, extended SMA population) runs in parallel, with a decision expected end of January 2027. Details below.
- Swissmedic's new medical-device registration fee is now live. CHF 200 for a first product, CHF 20 per additional device, capped at CHF 10,000 a year - payable for anything registered in swissdamed, with a transitional window running to 31 December 2026. Details below.
- G-BA opened a comment procedure on full cochlear-implant reimbursement on 10 September - a live look at how the G-BA treats a high-risk implanted device under the Section 137h corridor, with written statements due 12 October and an oral hearing on 12 November. Details below.
Germany
BfArM · G-BA · BMG 10 Sep 2026 Medical devices · HTA Transition
G-BA opens comment procedure on cochlear-implant reimbursement
The Gemeinsamer Bundesausschuss 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 for market accessImplant and device manufacturers should treat this as the live window to shape the reimbursement corridor for a high-risk (Section 137h-adjacent) device before the G-BA finalises its position - comments filed after 12 October will not be considered.
Ongoing, since 1 Aug 2026 AMNOG · Pricing & reimbursement Watch
G-BA benefit assessment for Itvisma (SMA gene therapy) running alongside new EU Joint Clinical Assessment output
G-BA's early benefit assessment procedure for onasemnogene abeparvovec (Itvisma, Novartis) in the extended SMA population (patients 2 years and older with ≥4 SMN2 gene copies, types 2/3/4) began 1 August 2026 under procedure number D-1353; the dossier assessment is due to publish 2 November 2026, with a G-BA decision expected end of January 2027. In parallel, the European Commission published a Joint Clinical Assessment report on an advanced therapy medicine for spinal muscular atrophy on 7 September 2026 and refreshed its overall list of ongoing JCAs on 10 September 2026.
Why it matters for market accessThis is one of the first visible cases of EU-level JCA evidence running concurrently with a German AMNOG procedure for an ATMP - worth tracking as a template for how JCA clinical conclusions are expected to feed (or not feed) national dossiers once JCA becomes mandatory reference material.
8 Sep 2026 Pharmacovigilance · Supply Transition
Federal Ministry of Health declares a critical digoxin/digitoxin shortage
The BMG notified a supply shortage for digoxin- and digitoxin-containing medicines on 8 September 2026, following Teva's report of 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, noting there is no aut-idem alternative and that switching patients to digoxin requires a dose adjustment for renal clearance.
Why it matters for market accessClients with cardiology or hospital-supply portfolios should check BfArM's shortage list before assuming continuity of supply for these substances into Q1 2027, and flag the DGK position paper to prescribing clients.
Since 1 Sep 2026 · confirm with BfArM Marketing authorisation · Process Watch
BfArM slot-allocation change extends to purely national procedures
Secondary reporting indicates that, as of 1 September 2026, BfArM's slot-allocation regime for assessment capacity now 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 press notice confirming the exact scope - sponsors with national submissions planned for Q4 2026 should confirm current slot requirements directly with BfArM before filing.
Why it matters for market accessIf confirmed, this changes submission-timeline planning for purely national (non-CP/non-MRP/DCP) filings in Germany - worth a direct check with BfArM before committing a filing date to a client.
Week of 8-15 Sep 2026 Market surveillance In force
Quiet week in Vienna - routine market surveillance only
We found no new Austrian pharma or medtech legislation, BASG/AGES policy change, or Erstattungskodex development dated to this window. BASG's own activity this week was limited to scheduled eServices system maintenance (8 September) and routine market-surveillance notices; the most recent Erstattungskodex amendment on record (the 257th) dates to late January 2026, not this week.
Why it matters for market accessNothing to action this week for Austria specifically - the item worth carrying forward is the EU pharma package and MDR/IVDR revision (see Watch list below), both of which apply to Austria once adopted.
Switzerland
Swissmedic · swissdamed In force since 1 Jul 2026 · transition to 31 Dec 2026 Medical devices · Registration fee In force
Swissmedic's revised Fees Ordinance now charges for swissdamed device registration
Following the Federal Council's approval of the revised Swissmedic Fees Ordinance, a registration fee now applies in swissdamed: CHF 200 for a manufacturer's first product, CHF 20 flat for each additional product with "on the market" status, capped at CHF 10,000 per calendar year. The ordinance also raised Swissmedic's time-based hourly rate to CHF 270 (from a rate unchanged since 2002), effective 1 July 2026. A transitional period for existing registrations runs to 31 December 2026.
Why it matters for market accessDevice and IVD clients placing products in Switzerland should budget the new registration fee into their Swiss compliance cost line now, and confirm which of their products still need to be registered before the transition window closes on 31 December 2026.
Ongoing · target end-2026 Marketing authorisation · eSubmission Watch
Swissmedic on track to complete eCTD v4.0 rollout by end of 2026
Swissmedic has confirmed it intends to complete technical implementation of eCTD v4.0 by the end of 2026, alongside a re-election of the full Agency Council for the 2026-2029 term and a federal funding increase contingent on Swissmedic hitting its own performance-improvement targets.
Why it matters for market accessSponsors preparing Swiss submissions on a 2027 timeline should plan for the eCTD v4.0 transition rather than the legacy format.
EU-wide
European Commission · HTACG 7 & 10 Sep 2026 HTA · Joint Clinical Assessment In force
Commission publishes a JCA report on an SMA advanced therapy and refreshes the JCA tracker
The European Commission published a Joint Clinical Assessment report on an advanced therapy medicine for spinal muscular atrophy on 7 September 2026, and issued an updated list of ongoing and completed joint clinical assessments on 10 September 2026 (15 JCAs initiated to date under the 2026 HTACG work programme, which for the first time includes selected high-risk medical devices in scope).
Why it matters for market accessSee the linked German AMNOG item above (Itvisma) for how this JCA output is landing on a national dossier in real time - useful precedent for any client with an ATMP or oncology asset entering JCA scope.
What we're tracking
- EU pharma package - Council's COREPER I endorsed the trilogue compromise texts on 6 March 2026; final European Parliament and Council approval is still pending, targeted for autumn 2026, with entry into force 20 days after Official Journal publication once adopted. Confirm current status with the Council before advising clients on a firm timeline. In ratification
- MDR/IVDR targeted revision - the Commission's proposal to simplify MDR/IVDR and delay select deadlines (published 16 December 2025) is moving through accelerated co-decision; no final adoption confirmed as of this edition. In ratification
- EU-Switzerland Mutual Recognition Agreement update - signed 2 March 2026 to restore mutual recognition of MDR/IVDR conformity-assessment certificates between the EU and Switzerland; not yet in force pending ratification on both sides. Devices certified in one market still cannot automatically rely on this until ratification completes. In ratification
- GKV-Beitragssatzstabilisierungsgesetz (Germany) - passed Bundestag and Bundesrat 10 July 2026 and published in the Bundesgesetzblatt on 29 July 2026; most operative measures phase in from 1 January 2027, including deferral of GKV loan repayments and preparatory work for a 2028 sugar-sweetened-beverage levy. Not a "this week" item, but the January 2027 phase-in is worth calendaring now for GKV-facing clients. Transition
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This digest is prepared for general information purposes and does not constitute legal advice. Regulatory status can change quickly, particularly for items marked "Transition," "Watch" or "In ratification" above - always confirm current status directly with the relevant regulator (BfArM, G-BA, BASG, Swissmedic or the European Commission) before relying on it for a filing or business decision. Compiled by BCA from primary regulator sources and reputable life-sciences reporting; all dates and links were verified at time of publication (15 September 2026).