Approval differences by country
43 approved and phase-3 products compared across 8 regulators. 0 are approved in all 8 regions, 3 are approved in the US but not the EU, and 2 are approved only in China. Filter by gap type to see where a pipeline exists in one region and is missing in another.
| Radioactive iodine (I-131) · Sodium iodide I-131 | Radiopharmaceutical (beta/gamma emitter, natural uptake) | 1951 | 1990 | 1990 | 1990 | 1990 | 1990 | · | · | 6/8 | 1951 US |
| Docetaxel · Taxotere (generic) | Cytotoxic chemotherapy (taxane) | 1996 | 1995 | 1995 | 1996 | 1996 | 1996 | · | · | 6/8 | 1995 EU/UK |
| Rituximab · Rituxan / MabThera (and biosimilars) | Monoclonal antibody (anti-CD20, chimeric) | 1997 | 1998 | 1998 | 2001 | 2000 | 1998 | · | 7/8 | 1997 US | |
| Samarium-153 lexidronam · Quadramet | Bone-seeking therapeutic radiopharmaceutical (beta emitter) | · | 1998 | · | · | · | · | · | · | 1/8 | 1998 EU |
| Temozolomide · Temodar | Oral alkylating chemotherapy | 1999 | 1999 | 1999 | 2006 | · | · | · | · | 4/8 | 1999 US/EU/UK |
| Ioflupane I-123 · DaTscan | SPECT tracer | · | 2000 | · | 2013 | · | · | · | · | 2/8 | 2000 EU |
| Thyrotropin alfa · Thyrogen | Recombinant human thyroid-stimulating hormone | · | 2000 | · | · | · | · | · | · | 1/8 | 2000 EU |
| Capecitabine · Xeloda | Oral fluoropyrimidine prodrug (antimetabolite) | · | 2001 | · | · | · | · | · | · | 1/8 | 2001 EU |
| Sorafenib · Nexavar | Small-molecule multi-kinase inhibitor (VEGFR, PDGFR, RAF) | 2005 | 2006 | 2006 | 2008 | 2006 | 2006 | · | 7/8 | 2005 US | |
| Sunitinib · Sutent | Small-molecule multi-kinase inhibitor (VEGFR, PDGFR, KIT) | 2006 | 2006 | 2006 | 2008 | 2007 | 2006 | · | · | 6/8 | 2006 US/EU/UK/AU |
| Everolimus · Afinitor | Small-molecule mTOR inhibitor | 2009 | 2009 | 2009 | 2010 | 2013 | 2009 | · | · | 6/8 | 2009 US/EU/UK/AU |
| Iobenguane I-123 (cardiac use) · AdreView | SPECT tracer | · | · | · | 2009 | · | · | · | · | 1/8 | 2009 JP |
| Cabazitaxel · Jevtana | Cytotoxic chemotherapy (taxane) | 2010 | 2011 | 2011 | 2014 | 2020 | 2011 | · | · | 6/8 | 2010 US |
| Abiraterone acetate · Zytiga (generic) | Small-molecule CYP17A1 inhibitor | 2011 | 2011 | 2011 | 2014 | 2015 | 2012 | · | 7/8 | 2011 US/EU/UK | |
| Cabozantinib · Cabometyx | Small-molecule multi-kinase inhibitor (MET, VEGFR2, AXL, RET) | 2012 | 2014 | 2014 | 2020 | 2023 | 2017 | · | · | 6/8 | 2012 US |
| Enzalutamide · Xtandi | Small-molecule AR antagonist | 2012 | 2013 | 2013 | 2014 | 2019 | 2014 | · | · | 6/8 | 2012 US |
| Florbetapir F-18 · Amyvid | PET tracer | · | 2013 | · | 2016 | · | · | · | · | 2/8 | 2013 EU |
| Radium-223 dichloride · Xofigo | Targeted alpha therapy (bone-seeking) | 2013 | 2013 | 2013 | 2016 | 2020 | 2014 | · | · | 6/8 | 2013 US/EU/UK |
| Technetium-99m tilmanocept · Lymphoseek | Radiopharmaceutical lymphatic mapping agent | 2013 | 2024 | 2014 | · | · | · | · | · | 2/8 | 2013 US |
| Florbetaben F-18 · Neuraceq | PET tracer | · | 2014 | · | · | 2023 | · | · | · | 2/8 | 2014 EU |
| Flutemetamol F-18 · Vizamyl | PET tracer | · | 2014 | · | 2017 | · | · | · | · | 2/8 | 2014 EU |
| Olaparib · Lynparza | Small-molecule PARP inhibitor | 2014 | 2014 | 2014 | 2018 | 2018 | 2016 | · | · | 6/8 | 2014 US/EU/UK |
| Pembrolizumab · Keytruda / Keytruda Qlex (SC) | Monoclonal antibody (anti-PD-1) | 2014 | 2015 | 2015 | 2016 | 2018 | 2015 | · | · | 6/8 | 2014 US |
| Fluciclovine F-18 · Axumin | PET radiotracer (synthetic amino acid) | 2016 | 2017 | 2017 | 2021 | · | · | · | · | 4/8 | 2016 US |
| Gallium-68 DOTATATE (and Cu-64 DOTATATE) · Netspot / Detectnet | PET radiotracer (somatostatin receptor ligand) | 2016 | · | · | · | · | · | 3/8 | 2016 US | ||
| Gallium-68 edotreotide (DOTATOC) | PET tracer | · | 2016 | · | · | · | · | · | · | 1/8 | 2016 EU |
| Durvalumab · Imfinzi | Monoclonal antibody (anti-PD-L1) | 2017 | 2018 | 2018 | 2018 | 2019 | 2018 | · | · | 6/8 | 2017 US |
| Lutetium-177 dotatate · Lutathera | Radioligand therapy (beta) | 2018 | 2017 | 2018 | 2021 | 2024 | 2018 | · | · | 6/8 | 2017 EU |
| Fluoroestradiol F-18 (FES PET) · Cerianna | PET radiotracer (oestrogen receptor ligand) | 2020 | · | · | · | · | · | · | · | 1/8 | 2020 US |
| Gallium-68 gozetotide (PSMA-11) · Illuccix / Gozellix / Locametz | PET imaging agent | 2020 | 2022 | 2022 | 2025 | 2025 | 2021 | · | · | 6/8 | 2020 US |
| 131I-MIBG (iobenguane I-131) therapy | Radioligand therapy (beta, norepinephrine transporter) | · | · | · | 2021 | · | · | · | · | 1/8 | 2021 JP |
| Donafenib · Zepsun | Small-molecule multi-kinase inhibitor (deuterated sorafenib) | · | · | · | 2021 | · | · | · | 1/8 | 2021 CN | |
| Piflufolastat F-18 / Pylarify TruVu · Pylarify | PET imaging agent | 2021 | 2023 | 2023 | · | · | · | · | · | 3/8 | 2021 US |
| Lutetium-177 vipivotide tetraxetan · Pluvicto | Radioligand therapy (beta) | 2022 | 2022 | 2023 | 2025 | 2025 | 2023 | · | · | 6/8 | 2022 US/EU |
| Flotufolastat F-18 · Posluma | PET imaging agent | 2023 | · | · | · | · | · | · | 1/8 | 2023 US | |
| Flortaucipir F-18 · Tauvid | PET tracer | · | 2024 | · | 2024 | · | · | · | · | 2/8 | 2024 EU/JP |
| Florastamin F-18 · ProstaView | PSMA-targeted PET radiotracer, fluorine-18 | · | · | · | · | · | · | 2026 | 1/8 | 2026 KR | |
| Technetium (99mTc) pexiretide · Jilunte | Integrin αvβ3-targeted SPECT imaging agent (RGD peptide dimer) | · | · | 2026 | · | · | · | 1/8 | 2026 CN | ||
| 177Lu-edotreotide | Radioligand therapy (beta) | · | · | · | · | · | · | 0/8 | - | ||
| 177Lu-PSMA-I&T | Radioligand therapy (beta) | · | · | · | · | · | · | 0/8 | - | ||
| Actinium-225 DOTATATE | Targeted alpha therapy | · | · | · | · | · | · | · | 0/8 | - | |
| Actinium-225 PSMA agents | Targeted alpha therapy | · | · | · | · | · | · | · | 0/8 | - | |
| Ibritumomab tiuxetan · Zevalin | Radioimmunotherapy (yttrium-90 labelled anti-CD20 antibody) | · | 2024 | · | · | · | · | · | · | 0/8 | - |
Approval lag by region
Years between the first approval anywhere and approval in each region, across products approved in that region. Zero means the region was among the first to approve.
| Region | Regulator | Approved | Median lag | Mean lag | First-in-world | Missing | Pending |
|---|---|---|---|---|---|---|---|
| United States | FDA | 24 | 0 yr | 0.1 yr | 22 | 14 | 5 |
| European Union | EMA / European Commission | 30 | 0 yr | 1.8 yr | 18 | 8 | 3 |
| United Kingdom | MHRA (NICE for reimbursement) | 22 | 1 yr | 2.6 yr | 7 | 16 | 0 |
| Japan | PMDA / MHLW | 25 | 3 yr | 4.8 yr | 3 | 13 | 0 |
| China | NMPA | 20 | 4 yr | 6.1 yr | 2 | 18 | 0 |
| Australia | TGA (PBS for reimbursement) | 17 | 1 yr | 3.5 yr | 2 | 21 | 0 |
| India | CDSCO (DCGI) | 3 | - | - | 0 | 35 | 0 |
| South Korea | MFDS | 1 | 0 yr | 0.0 yr | 1 | 37 | 0 |
How to read this
Each cell is the regulator’s decision for the product in that region: the year of first approval, a tick for full approval, ✓c for conditional or accelerated approval, … for a filing under review, a dash where the sponsor has said it will not file, and ✕ for a withdrawn or rejected application. A dot means we have no sourced record, which is not the same as “not approved”.
“First” is the earliest year of approval in any of the regions and the region(s) that granted it. Lag is measured in whole years against that first approval. “Missing” counts products approved somewhere but not in the region.
Regions: US = FDA, EU = EMA / European Commission, UK = MHRA (NICE for reimbursement), JP = PMDA / MHLW, CN = NMPA, AU = TGA (PBS for reimbursement), IN = CDSCO (DCGI), KR = MFDS. UK entries reflect MHRA marketing authorisation, not NICE reimbursement; Australian entries reflect TGA registration, not PBS listing; Indian entries reflect CDSCO approval or documented generic and biosimilar entry, and are recorded only where sourced.
Sourcing caveat
US entries are seeded from the product corpus, which cites FDA approval notices. EU entries link to the EMA public assessment report; a small filled dot on a cell marks rows checked directly against the EPAR page. UK, Japan, China, Australia and India entries link to regulator search pages or company releases and are stated at year resolution only. Years for legacy chemotherapies predate online registers and are approximate.
This matrix is a work in progress. Approvals happen weekly, indications differ between regions even when a product is approved in both, and a missing cell most often means we have not yet sourced it. Verify at the regulator before relying on any cell. Corrections are welcome via the repo.