EU regulatory changelog
- 2026-07-15🇪🇺 EU-widehighApproval
EU approval: Wegovy pill (oral semaglutide)
15 July 2026: the European Commission approved the Wegovy pill (oral semaglutide) as the first oral GLP-1 receptor agonist for weight management in the EU. A single ready-to-use 7.2 mg higher-dose pen was approved at the same time.
View Semaglutide → - 2026-05-21🇪🇺 EU-widehighLabel change
CHMP: positive opinion for oral Wegovy (semaglutide)
21 May 2026: EMA's CHMP adopted a positive opinion for a new pharmaceutical form of Wegovy — oral tablets (1.5 / 4 / 9 / 25 mg) for weight management. The first oral GLP-1 receptor agonist for this indication. In the OASIS 4 trial, 25 mg once daily showed 16.6% mean weight loss.
View Semaglutide → - 2026-03-26🇪🇺 EU-widemediumApproval
EMA CHMP March 2026: 5 new medicines + 13 indication extensions
At the 23-26 March 2026 meeting, EMA's CHMP recommended approval of 5 new medicines and 13 extensions of therapeutic indications for existing marketing authorisations — including metabolic/endocrine indications.
View Semaglutide → - 2026-03-19🇪🇺 EU-widehighLabel change
Retatrutide: TRIUMPH-4 published — 28.7% weight loss
March 2026: full Phase 3 TRIUMPH-4 results from Eli Lilly were published, showing 28.7% average body weight loss — the highest ever recorded in an obesity clinical trial. Seven additional TRIUMPH trials are expected throughout 2026, with NDA filing to the FDA expected in late 2026.
View Retatrutide → - 2026-02-15🇬🇧 United KingdomhighReimbursement
NICE NG28: widened access to GLP-1s & SGLT-2 inhibitors for T2D
February 2026: NICE updated guideline NG28 on type 2 diabetes management in adults, widening access to GLP-1 receptor agonists (liraglutide, dulaglutide, semaglutide up to 1mg/week) and SGLT-2 inhibitors. Estimated to prevent up to 17,000 deaths in the UK over 3 years.
View Semaglutide → - 2026-01-29🇪🇺 EU-widemediumApproval
EMA CHMP January 2026: 6 new approvals + 9 extensions
At the 26-29 January 2026 meeting, CHMP recommended 6 new medicine approvals and 9 indication extensions — the first major EMA-level regulatory decision of 2026.
View Semaglutide → - 2025-12-11🇪🇺 EU-widehighLabel change
EMA CHMP: positive opinion on Mounjaro® marketing authorisation variation
On 11 December 2025 EMA's CHMP adopted a positive opinion recommending a change to the marketing authorisation terms for Mounjaro® (tirzepatide) at EU level.
View Tirzepatide → - 2025-09-03🇪🇺 EU-widehighScheduling
EMA warning: sharp rise in illegal GLP-1 medicines sold in the EU
EMA and the HMA issued a joint warning about illegal medicines sold as GLP-1 receptor agonists for weight loss and diabetes, posing serious health risks.
View Semaglutide → - 2025-09-01🇬🇧 United KingdomhighReimbursement
NICE TA1026: commercial arrangement added for Mounjaro® in weight management
September 2025: NICE added the commercial arrangement to the TA1026 recommendation and updated tirzepatide pricing for overweight/obesity management on the NHS.
View Tirzepatide → - 2025-08-15🇪🇺 EU-widemediumLabel change
Retatrutide: remains investigational — Phase 3 ongoing
Retatrutide (Eli Lilly, LY3437943) remains unapproved by FDA/EMA. TRIUMPH (obesity) and TRANSCEND (cardiovascular) Phase 3 programs are ongoing with regulatory submission expected from 2026 onwards.
View Retatrutide → - 2025-05-12🇪🇺 EU-widemediumLabel change
EASO: semaglutide & tirzepatide as first-line obesity treatment
The European Association for the Study of Obesity (EASO) issued new framework recommending semaglutide and tirzepatide as first-line pharmacotherapy for obesity and most of its complications.
View Tirzepatide → - 2025-03-21🇪🇺 EU-widehighShortage
FDA: semaglutide & tirzepatide shortages officially resolved — stricter compounding rules
FDA confirmed that semaglutide and tirzepatide shortages are officially resolved, triggering restrictions on 503A/503B pharmacy compounding in the US — with downstream effects on the global market.
View Semaglutide → - 2025-01-15🇬🇧 United KingdomhighReimbursement
Mounjaro® available via NHS for weight management
NICE approved rollout for weight management with phased access over the next 3 years.
View Tirzepatide → - 2024-12-01 FrancehighReimbursement
Wegovy®: Sécurité Sociale coverage expanded
Reimbursement extended to patients with BMI ≥35 and comorbidity.
View Semaglutide → - 2024-11-20🇪🇺 EU-widehighShortage
EMA notice: prolonged Ozempic® shortage
EMA confirmed ongoing shortage until Q2 2025 across 0.25mg, 0.5mg and 1mg pens.
View Semaglutide → - 2024-10-08🇪🇺 EU-widemediumLabel change
Retatrutide: Phase III interim data published
Eli Lilly published Phase III interim showing average -24% body weight at 48 weeks.
View Retatrutide → - 2024-09-12🇩🇪 GermanymediumScheduling
BfArM: enhanced customs scrutiny for BPC-157
New Zoll directive to seize research peptide parcels from non-EU sources.
View BPC-157 → - 2024-07-01🇬🇷 GreecehighApproval
Mounjaro® launches in Greece
Official launch of 2.5/5/7.5/10/12.5/15mg in Greek pharmacies with EOPYY for T2D.
View Tirzepatide → - 2024-06-18🇵🇱 PolandhighShortage
URPL: severe Ozempic® shortage in Poland
URPL recorded widespread shortage leading to T2D prescription rationing.
View Semaglutide → - 2024-05-10🇪🇺 EU-widelowScheduling
WADA: TB-500 confirmed as prohibited substance
WADA updated the 2024 list keeping thymosin β4 fragment as S2 anabolic agent.
View TB-500 (Thymosin β4) →