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October 28, 2026CompoundingHHS lets 503A pharmacies compound six peptides under an interim enforcement discretion policyOctober 28, 2026Trial resultRetatrutide beats Ozempic on blood sugar and weight in head-to-head TRANSCEND-T2D-2 trialOctober 23, 2026FDA approvalFDA extends once-weekly insulin icodec (Awiqli) to children 10 and older with type 2 diabetesOctober 21, 2026CompoundingCitizen petition asks FDA not to allow compounding of seven peptides reviewed by its advisory committeeOctober 1, 2026Trial resultSurvodutide SYNCHRONIZE-2 phase 3 results in obesity with type 2 diabetes published in NEJMSeptember 30, 2026Trial resultEloraTZP (eloralintide plus tirzepatide) phase 2 results presented at EASD 2026September 30, 2026Trial resultOrforglipron ACHIEVE-4 cardiovascular safety trial published in The LancetSeptember 29, 2026Trial resultFull TRIUMPH-2 retatrutide results published in The LancetSeptember 24, 2026FDA approvalFDA approves insulin efsitora alfa (Onswik), a once-weekly basal insulin for type 2 diabetesSeptember 21, 2026WADAWADA publishes 2027 Prohibited List, naming peptides as examples of non-approved substances

October 28, 2026CompoundingHHS lets 503A pharmacies compound six peptides under an interim enforcement discretion policyOctober 28, 2026Trial resultRetatrutide beats Ozempic on blood sugar and weight in head-to-head TRANSCEND-T2D-2 trialOctober 23, 2026FDA approvalFDA extends once-weekly insulin icodec (Awiqli) to children 10 and older with type 2 diabetesOctober 21, 2026CompoundingCitizen petition asks FDA not to allow compounding of seven peptides reviewed by its advisory committeeOctober 1, 2026Trial resultSurvodutide SYNCHRONIZE-2 phase 3 results in obesity with type 2 diabetes published in NEJMSeptember 30, 2026Trial resultEloraTZP (eloralintide plus tirzepatide) phase 2 results presented at EASD 2026September 30, 2026Trial resultOrforglipron ACHIEVE-4 cardiovascular safety trial published in The LancetSeptember 29, 2026Trial resultFull TRIUMPH-2 retatrutide results published in The LancetSeptember 24, 2026FDA approvalFDA approves insulin efsitora alfa (Onswik), a once-weekly basal insulin for type 2 diabetesSeptember 21, 2026WADAWADA publishes 2027 Prohibited List, naming peptides as examples of non-approved substances

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How a peptide becomes a medicine · Part 5: Around the world

Europe and the EMA

Lesson 6.5.1 · 6 min read · Professional plan

What you'll learn

EMA evaluates, and the European Commission grants, a single authorisation valid across the EU, Iceland, Liechtenstein and Norway.
The CHMP's review takes up to 210 active days. The Commission decides within 67 days of the opinion.
The central route is required for new diabetes medicines, biotech medicines, advanced therapies and orphan medicines, among others.
Most generics and over-the-counter medicines are authorised nationally, through mutual recognition or the decentralised procedure.

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